Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02531633
• Collaborator: (none)
• Enrollment: 161
• Locations: 63
• Arms: 6
• Actual Duration (Months): 29.1
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in the treatment of active GCA. The study will be conducted in 2 distinct parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the option to receive open-label sirukumab based on disease status and a 16-week follow-up phase if applicable.

Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week 52. Subjects completing Part A of the study will be eligible to enter Part B, the 104-week extension phase, designed to investigate the long-term maintenance of remission and safety following cessation of sirukumab treatment and to assess long-term corticosteroid use. Subjects with active GCA at the end of Part A or those with new onset of GCA flare during the first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable only for those who are withdrawn prematurely from the study or whose open-label sirukumab treatment in Part B completes after Week 88.

Condition or Disease	Intervention/Treatment	Phase
Giant Cell Arteritis	Drug: Sirukumab; Drug: Placebo to match sirukumab; Drug: Prednisone; Drug: Placebo to match prednisone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 161 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis
• Actual Study Start Date: Oct 16, 2015
• Actual Primary Completion Date: Mar 21, 2018
• Actual Study Completion Date: Mar 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: Sirukumab, Dose 1+prednisone (6-month taper) Subjects will receive blinded sirukumab 100 mg subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.	Drug: Sirukumab; Sirukumab will be provided as 1 millilitre (mL) Pre-filled Syringe (PFS), containing 100 mg/mL or 50 mg/mL of sirukuma, fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.; Drug: Prednisone; Prednisone will be provided as tablets with dosage level up to-60 mg/day. The prednisone dose for all subjects will be determined by the Investigator and starting doses will be within 20-60 mg prednisone at Baseline (Randomization).; Drug: Placebo to match prednisone; Placebo to match prednisone will be provided as tablets.
Experimental: Part A: Sirukumab, Dose 1+prednisone (3-month taper) Subjects will receive blinded sirukumab 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month oral prednisone taper regimen.	Drug: Sirukumab; Sirukumab will be provided as 1 millilitre (mL) Pre-filled Syringe (PFS), containing 100 mg/mL or 50 mg/mL of sirukuma, fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.; Drug: Prednisone; Prednisone will be provided as tablets with dosage level up to-60 mg/day. The prednisone dose for all subjects will be determined by the Investigator and starting doses will be within 20-60 mg prednisone at Baseline (Randomization).; Drug: Placebo to match prednisone; Placebo to match prednisone will be provided as tablets.
Experimental: Part A: Sirukumab, Dose 2+prednisone (6-month taper) Subjects will receive blinded sirukumab 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.	Drug: Sirukumab; Sirukumab will be provided as 1 millilitre (mL) Pre-filled Syringe (PFS), containing 100 mg/mL or 50 mg/mL of sirukuma, fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.; Drug: Prednisone; Prednisone will be provided as tablets with dosage level up to-60 mg/day. The prednisone dose for all subjects will be determined by the Investigator and starting doses will be within 20-60 mg prednisone at Baseline (Randomization).; Drug: Placebo to match prednisone; Placebo to match prednisone will be provided as tablets.
Placebo Comparator: Part A:Placebo to match sirutkumab+prednisone (6-month taper) Subjects will receive blinded placebo to match sirutkumab q2w for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.	Drug: Placebo to match sirukumab; Placebo to match sirukumab will be provided as 1.0 mL PFS fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.; Drug: Prednisone; Prednisone will be provided as tablets with dosage level up to-60 mg/day. The prednisone dose for all subjects will be determined by the Investigator and starting doses will be within 20-60 mg prednisone at Baseline (Randomization).; Drug: Placebo to match prednisone; Placebo to match prednisone will be provided as tablets.
Placebo Comparator: Part A:Placebo to match sirukumab+prednisone (12-month taper) Subjects will receive blinded placebo to match sirutkumab q2w for 52 weeks plus a pre-specified maximum of 12-month oral prednisone taper regimen.	Drug: Placebo to match sirukumab; Placebo to match sirukumab will be provided as 1.0 mL PFS fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.; Drug: Prednisone; Prednisone will be provided as tablets with dosage level up to-60 mg/day. The prednisone dose for all subjects will be determined by the Investigator and starting doses will be within 20-60 mg prednisone at Baseline (Randomization).; Drug: Placebo to match prednisone; Placebo to match prednisone will be provided as tablets.
Experimental: Part B:Open-label sirukumab 100 mg SC (if applicable) Subjects completing Part A will receive open label 100 mg SC q2w for a maximum of 52 weeks based on remission status and disease activity at the primary 52-week endpoint or prednisone tapering status of subject during Part A. Methotrexate will be provided to subjects, alone or in addition to sirukumab treatment during Part B, based on the discretion of the investigator.	Drug: Sirukumab; Sirukumab will be provided as 1 millilitre (mL) Pre-filled Syringe (PFS), containing 100 mg/mL or 50 mg/mL of sirukuma, fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.

Outcome Measures

Primary Outcome Measures

1. Part A: Number of Participants in Sustained Remission at Week 52 [Week 52]

   Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) [<30 millimeters per hour] and C-reactive Protein (CRP) [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis.

Secondary Outcome Measures

1. Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 [Week 24]

   Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30 millimeters per hour] and CRP [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP.

2. Part A: Cumulative Prednisone Dose Over Time [Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

   Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg.

3. Part B: Number of Participants in Sustained Remission Over Time [Weeks 4, 8 and 12]

   Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis.

4. Part A: Time to First Disease Flare After Clinical Remission [Week 52]

   Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented.

5. Part B: Time to First Disease Flare for Participants in Sustained Remission [Week 52]

   Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented.

6. Part A: Number of Disease Flares Over Time [Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

   This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented.

7. Part A: Number of Participants With at Least One Hospitalization for Disease Flare [Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

   Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented.

8. Part A: Number of Hospitalizations for Disease Flare Over Time [Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

   Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented.

9. Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time [Baseline (Week 0), Weeks 12, 24, 36, 52]

   SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for Physical Component Summary (PCS), Mental Component Summary (MCS) scores was presented.

10. Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time [Baseline (Week 0) and Weeks 12, 24, 36, 52]

    EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score).

11. Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time [Baseline (Week 0) and Weeks 12, 24, 36, 52]

    EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score). The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'.

12. Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time [Baseline (Week 0), Weeks 12, 24, 36, 52]

    The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Each negatively-worded item response was recoded so that 0 is a bad response and 4 is good response. All responses were added with equal weight to obtain the total score. The total score was calculated as the sum of all the individual items after recoding some of the items.

13. Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time [Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

    The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain on a 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Data for NRS scores over time for part A is reported.

14. Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time [Baseline (Week 0) and Weeks 12, 24, 36 and 52]

    Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability.

15. Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time [Weeks 12, 24 and 52]

    Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.

16. Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time [Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

    The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS) of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor").

17. Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time [Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

    The Physician's Global Assessments of Disease Activity was recorded on a VAS of 10 cm ranging from 0 ("none") to 10 ("extremely active").

18. Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time [Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

    Blood samples were collected for analysis of CRP. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in serum CRP over time for part A was reported. The Safety set comprised of all randomized participants who received at least 1 dose of SC IP.

19. Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time [Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

    Blood samples were collected for analysis of ESR. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in ESR over time for part A was reported.

20. Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs [Up to 52 weeks]

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs have been reported.

21. Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    SBP and DBP were measured in semi-supine position after 5 minutes rest at indicated time points. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

22. Part A: Change From Baseline in Pulse Rate [Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Pulse rate was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

23. Part A: Change From Baseline in Temperature [Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Temperature was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

24. Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets [Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

25. Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin [Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

26. Part A: Change From Baseline in Hematology Parameter-Hematocrit [Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

27. Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume [Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

28. Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin [Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

29. Part A:Change From Baseline in Hematology Parameter- Erythrocytes [Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

30. Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea [Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea . Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

31. Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein [Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

32. Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) [Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

33. Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin [Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52]

    Blood samples were collected to analyze the chemistry parameters including bilirubin, creatinine, direct bilirubin and indirect bilirubin. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

34. Part A: Mean Serum Concentrations of Sirukumab [Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52]

    Blood samples for Pharmacokinetic analysis of sirukumab serum concentrations were planned to be collected at specified time points.

35. Part A: Mean Serum Anti-sirukumab Antibodies [Baseline (Week 0) and up to 52 weeks]

    Blood samples for Pharmacokinetic analysis of Serum anti-sirukumab antibodies were planned to be collected at specified time points.

36. Part A: Change From Baseline in Free and Total Interleukin-6 (IL-6) Over Time [Baseline (Week 0) and up to 52 weeks]

    Blood samples for Pharmacodynamic analysis were planned but not collected due to early termination of study.

37. Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Up to 120 weeks]

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.

38. Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B [Up to 120 weeks]

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.

39. Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)]

    SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

40. Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)]

    SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

41. Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)]

    Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

42. Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)]

    Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented.

43. Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)]

    Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

44. Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)]

    Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

45. Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

46. Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

    Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

47. Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

48. Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

    Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

49. Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

50. Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

    Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

51. Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

52. Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

    Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

53. Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.

54. Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

    Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

55. Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.

56. Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

    Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

57. Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.

58. Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

    Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

59. Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

60. Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

    Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

61. Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

62. Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

    Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented

63. Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

64. Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Baseline (Week 0) and Weeks 4,8,12,16,24 and 36]

    Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

65. Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B [Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38]

    Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented.

66. Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B [Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38]

    Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented.

67. Part B: Number of Disease Flares Over Time [Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented.

68. Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare [Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: "Severe Flare including Hospitalizations". Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.

69. Part B: Number of Hospitalizations for Disease Flare Over Time [Up to Week 104]

    Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: "Severe Flare including Hospitalizations". Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.

70. Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24]

    SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who received at least one dose of 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

71. Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B [Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12]

    SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who never received 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

72. Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24]

    EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

73. Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B [Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12]

    EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

74. Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24]

    The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

75. Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B [Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24]

    The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.

76. Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24]

    The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

77. Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B [Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24]

    The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.

78. Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Day 87, 339, 344, Week 12, 24]

    Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability

79. Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B [Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12]

    Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability

80. Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344]

    The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

81. Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B [Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373]

    The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.

82. Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40]

    In PhGA was based on "What is physician's assessment of the participant's current disease activity". PhGA used a 10 cm VAS ranging from 0 ("none") to 10 ("extremely active"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

83. Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B [Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373]

    In PhGA was based on "What is physician's assessment of the participant's current disease activity". PhGA used a 10 cm VAS ranging from 0 ("none") to 10 ("extremely active"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.

84. Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Baseline (Day 1), Days 103 and 271]

    Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.

85. Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B [Baseline (Day 1)]

    Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.

86. Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

87. Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B [Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36]

    Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

88. Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40]

    Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

89. Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B [Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36]

    Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

90. Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B [Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24]

    EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

91. Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B [Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12]

    EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 100 (Best imaginable health state) and 0 (Worst imaginable health state). Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of GCA defined by the following Revised GCA Diagnosis Criteria:

Age >=50 years. History of ESR >=50 millimeter/hour (mm/hour) or CRP >=2.45 milligram/deciliter(mg/dL).

Presence of at least one of the following: Unequivocal cranial symptoms of GCA; Unequivocal symptoms of polymyalgia rheumatic (PMR).

Presence of at least one of the following: Temporal artery biopsy revealing features of GCA; Evidence of large-vessel vasculitis by angiography or cross-sectional imaging.

• Active GCA within 6 weeks of Randomization (Baseline) where active disease is defined by an ESR >=30 mm/hr or CRP >=1 mg/dL AND the presence of at least one of the following:

Unequivocal cranial symptoms of GCA; Unequivocal symptoms of PMR; Other features judged by the clinician investigator to be consistent with GCA or PMR flares.

• At screening, receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.

• Clinically stable GCA disease at baseline such that the subject is able to safely participate in the blinded prednisone taper regimen in the opinion of the investigator.

• Practicing acceptable methods of birth control if a female of child-bearing potential.

• No evidence of active or latent infection with Mycobacterium tuberculosis (TB).

Exclusion Criteria:

• Are pregnant or breastfeeding.

• Recent (within the past 12 weeks) or planned major surgery that would impact on study procedures or assessments.

• Organ transplantation recipients (except corneas within 3 months prior to baseline visit).

• Had prior treatment with any of the following:

Systemic immunosuppressives) within 4 weeks of baseline; Biologic agents targeted at reducing tumor necrosis factor-alpha (TNF-alpha) within 2-8 weeks of baseline, depending on the agent; Any prior use of tocilizumab or other anti-IL-6 agents; B-cell depleting agents (eg, rituximab) within 12 months prior to baseline or longer if B cell counts have not returned to normal range or baseline levels; Cytotoxic drugs such as cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents within 4 weeks of baseline; Abatacept within 8 weeks of baseline; Tofacitinib within 4 weeks of baseline; Methotrexate use within 2 weeks of baseline.

Methylprednisolone > 100 mg/day intravenous (IV) (or equivalent) within 8 weeks of baseline.

• History of severe allergic reactions to monoclonal antibodies, human proteins, or excipients.

• Evidence of serious concomitant disease, which in the opinion of the investigator makes them unsuitable for participation in the study.

• Major ischemic event, unrelated to GCA, within 12 weeks of screening.

• Marked baseline prolongation of corrected QT (QTc) interval >= 450 milliseconds (msec) (QTc by Bazett's formula [QTcB ]or QTc by Fridericia's formula [QTcF] ), history of Torsade de Pointes, family history of long QT syndrome, history of second or third degree heart block.

• Current liver disease that could interfere with the trial

• History of or current active diverticulitis, inflammatory bowel disease, or other symptomatic gastrointestinal tract condition that might predispose to bowel perforation.

• History of known demyelinating diseases such as multiple sclerosis or optic neuritis.

• Active infections, or history of recurrent infections or have required management of acute or chronic infections, as follows:

Currently on any suppressive therapy for a chronic infection, history or suspicion of chronic infection, hospitalization for treatment of infection within 60 days of the baseline visit, or use of parenteral (IV) or intra-muscular [IM]) antimicrobials within 60 days of baseline or oral antimicrobials within 30 days of baseline

• Primary or secondary immunodeficiency or any other autoimmune disease.

• Human immunodeficiency virus (HIV) infection, hepatitis C or hepatitis B infection

• Live virus or bacterial vaccination within 3 months before the first administration of study drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Aurora	Colorado	United States	80210
2	GSK Investigational Site	Boca Raton	Florida	United States	33486
3	GSK Investigational Site	Naples	Florida	United States	34102
4	GSK Investigational Site	Iowa City	Iowa	United States	52242
5	GSK Investigational Site	Boston	Massachusetts	United States	02111
6	GSK Investigational Site	Boston	Massachusetts	United States	02114
7	GSK Investigational Site	Rochester	Minnesota	United States	55905
8	GSK Investigational Site	New York	New York	United States	10021
9	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19104
10	GSK Investigational Site	Jackson	Tennessee	United States	38305
11	GSK Investigational Site	Dallas	Texas	United States	75231
12	GSK Investigational Site	Seattle	Washington	United States	98101
13	GSK Investigational Site	Vancouver	Washington	United States	98664
14	GSK Investigational Site	Camperdown	New South Wales	Australia	2050
15	GSK Investigational Site	Kogarah	New South Wales	Australia	2217
16	GSK Investigational Site	Woodville	South Australia	Australia	5011
17	GSK Investigational Site	Heidelberg	Victoria	Australia	3084
18	GSK Investigational Site	Malvern East	Victoria	Australia	3145
19	GSK Investigational Site	Victoria Park	Western Australia	Australia	6100
20	GSK Investigational Site	Leuven		Belgium	3000
21	GSK Investigational Site	Liège		Belgium	4000
22	GSK Investigational Site	Plovdiv		Bulgaria	4001
23	GSK Investigational Site	Sofia		Bulgaria	1612
24	GSK Investigational Site	Bobigny		France	93009
25	GSK Investigational Site	Orleans		France	45067
26	GSK Investigational Site	Paris		France	75018
27	GSK Investigational Site	Paris		France	75679
28	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg	Germany	72076
29	GSK Investigational Site	Hannover	Niedersachsen	Germany	30625
30	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen	Germany	40225
31	GSK Investigational Site	Dresden	Sachsen	Germany	01307
32	GSK Investigational Site	Jena	Thueringen	Germany	07747
33	GSK Investigational Site	Bad Abbach		Germany	93077
34	GSK Investigational Site	Berlin		Germany	13125
35	GSK Investigational Site	Berlin		Germany	14059
36	GSK Investigational Site	Hamburg		Germany	22763
37	GSK Investigational Site	Kirchheim unter Teck		Germany	73230
38	GSK Investigational Site	München		Germany	80336
39	GSK Investigational Site	Budapest		Hungary	1097
40	GSK Investigational Site	Debrecen		Hungary	4032
41	GSK Investigational Site	Reggio Emilia	Emilia-Romagna	Italy	42100
42	GSK Investigational Site	Milano	Lombardia	Italy	20132
43	GSK Investigational Site	Rozzano		Italy	20089
44	GSK Investigational Site	Almelo		Netherlands	7609 PP
45	GSK Investigational Site	Groningen		Netherlands	9713 GZ
46	GSK Investigational Site	Nijmegen		Netherlands	6525 GA
47	GSK Investigational Site	Hamilton		New Zealand	3240
48	GSK Investigational Site	Timaru		New Zealand	7910
49	GSK Investigational Site	Krakow		Poland	31-121
50	GSK Investigational Site	Barcelona		Spain	08036
51	GSK Investigational Site	Barcelona		Spain	08208
52	GSK Investigational Site	Barcelona		Spain	08907
53	GSK Investigational Site	Bilbao		Spain	48013
54	GSK Investigational Site	La Coruña		Spain	15006
55	GSK Investigational Site	La Laguna		Spain	38320
56	GSK Investigational Site	Westcliff-on-Sea	Essex	United Kingdom	SS0 0RY
57	GSK Investigational Site	Wirral	Merseyside	United Kingdom	CH49 9PE
58	GSK Investigational Site	Bury St. Edmunds	Suffolk	United Kingdom	IP33 2QZ
59	GSK Investigational Site	Sheffield	Yorkshire	United Kingdom	S10 2JF
60	GSK Investigational Site	Edinburgh		United Kingdom	EH4 2XR
61	GSK Investigational Site	Leeds		United Kingdom	LS9 7TF
62	GSK Investigational Site	Oxford		United Kingdom	OX3 7LD
63	GSK Investigational Site	Reading		United Kingdom	RG1 5AN

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Nov 17, 2016
• Statistical Analysis Plan - Jun 4, 2018

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02531633
• Other Study ID Numbers: 201677
• First Posted: Aug 24, 2015
• Last Update Posted: Jul 31, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Giant Cell Arteritis, Sirukumab, Prednisone
• Additional relevant MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis; Prednisone; Antibodies, Monoclonal

Study Results

Participant Flow

Recruitment Details	This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of sirukumab in treatment of participants with Giant Cell Arteritis (GCA). A total of 161 participants were enrolled.
Pre-assignment Detail	This study was conducted in 2 distinct parts (Part A and Part B), Part A was a 52-week double-blind treatment phase and Part B was a 104-week long-term extension phase with the option to receive open-label sirukumab (SIR) (up to a 52-week duration of open-label treatment). This study was terminated early by sponsor.

Arm/Group Title	Part A:SIR 100 mg SC q2w+6 Month Prednisone	Part A:SIR 100 mg SC q2w+3 Month Prednisone	Part A:SIR 50 mg SC q4w+6 Month Prednisone	Part A:Placebo SC q2w + 6 Month Prednisone	Part A:Placebo SC q2w+12 Month Prednisone	Part B:SIR 100 mg SC q2w+6 Month Prednisone	Part B:SIR 100 mg SC q2w+3 Month Prednisone	Part B:SIR 50 mg SC q4w+6 Month Prednisone	Part B:Placebo SC q2w + 6 Month Prednisone	Part B:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Period Title: Part A (52 Weeks)
STARTED	42	39	26	27	27	0	0	0	0	0
Completed Part A and Didn't Enter Part B	1	0	1	0	0	0	0	0	0	0
COMPLETED	8	5	4	5	4	0	0	0	0	0
NOT COMPLETED	34	34	22	22	23	0	0	0	0	0
Period Title: Part A (52 Weeks)
STARTED	0	0	0	0	0	8	5	4	5	4
COMPLETED	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	8	5	4	5	4

Baseline Characteristics

Arm/Group Title	SIR100 mg SC q2w+6 Month Prednisone	SIR 100 mg SC q2w+3 Month Prednisone	SIR 50 mg SC q4w+6 Month Prednisone	Placebo SC q2w + 6 Month Prednisone	Placebo SC q2w + 12 Month Prednisone	Total
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen	Total of all reporting groups
Overall Participants	42	39	26	27	27	161
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	70.5 (7.25)	68.1 (6.72)	67.5 (9.45)	71.6 (7.10)	70.7 (8.96)	69.6 (7.85)
Sex: Female, Male (Count of Participants)
Female	31 73.8%	30 76.9%	19 73.1%	23 85.2%	21 77.8%	124 77%
Male	11 26.2%	9 23.1%	7 26.9%	4 14.8%	6 22.2%	37 23%
Race/Ethnicity, Customized (Count of Participants)
African American/African Heritage	0 0%	1 2.6%	0 0%	0 0%	0 0%	1 0.6%
White: Arabic/North African Heritage	1 2.4%	1 2.6%	0 0%	0 0%	0 0%	2 1.2%
White/Caucasian/European Heritage	41 97.6%	37 94.9%	25 96.2%	26 96.3%	27 100%	156 96.9%
Mixed Race	0 0%	0 0%	1 3.8%	1 3.7%	0 0%	2 1.2%

Outcome Measures

1. Primary Outcome

Title	Part A: Number of Participants in Sustained Remission at Week 52
Description	Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) [<30 millimeters per hour] and C-reactive Protein (CRP) [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population comprised of all randomized participants who received at least 1 dose of SC investigational product (IP).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	17	13	9	9	7
Count of Participants [Participants]	3 7.1%	2 5.1%	1 3.8%	0 0%	0 0%

2. Secondary Outcome

Title	Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24
Description	Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30 millimeters per hour] and CRP [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

ITT-Part B Population included all randomized participants who received at least 1 dose of SC IP in Part A and entered Part B.

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	Part B:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	Part B:Placebo SC q2w + 6 Month Prednisone	Part B:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	2	1	0	0
Count of Participants [Participants]	NA NaN	NA NaN	NA NaN

3. Secondary Outcome

Title	Part A: Cumulative Prednisone Dose Over Time
Description	Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg.
Time Frame	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2, n= 40,39,26,27,26	439.575 (237.8990)	464.923 (299.6445)	424.577 (270.2183)	432.815 (315.6851)	430.846 (241.3540)
Week 4,n=40,39,26,25,27	701.100 (370.9798)	741.115 (436.4205)	701.192 (439.7251)	705.480 (601.9706)	751.407 (431.3442)
Week 8,n=37, 37,26,23,26	1086.676 (600.7400)	987.730 (559.4458)	1014.731 (592.3515)	1161.391 (1202.8504)	1129.077 (546.8037)
Week 12,n=34,32,24,22,24	1344.441 (779.6775)	1063.773 (619.4002)	1208.167 (650.6975)	1379.409 (1255.4397)	1462.917 (630.1717)
Week 16,n=32,30,24,22,22	1545.602 (964.3264)	1182.288 (718.6186)	1348.750 (689.2484)	1672.795 (1261.7121)	1729.977 (701.3734)
Week 20,n=29,27,21,24,19	1690.302 (1173.6005)	1339.546 (888.5007)	1475.786 (734.7667)	1646.177 (701.5240)	2041.632 (771.3504)
Week 24,n=30,25,19,18,17	1878.458 (1333.1175)	1495.015 (1055.9615)	1626.342 (813.8284)	1917.444 (861.6887)	2299.471 (840.8758)
Week 28,n=24,23,15,17,15	2000.813 (1594.5982)	1575.549 (1170.7294)	1797.533 (933.3753)	2141.294 (1082.2754)	2387.800 (741.1663)
Week 32,n=19,21,13,15,18	2216.000 (1953.8211)	1716.863 (1328.1426)	1859.346 (858.5431)	2531.417 (1327.9125)	2404.500 (808.8642)
Week 36,n=19,17,14,13,14	2321.711 (2090.2393)	1803.919 (1536.5304)	1705.214 (802.8858)	2617.817 (1636.2516)	2717.696 (897.0689)
Week 40,n=18,15,11,13,12	2003.264 (1426.0271)	2023.342 (1651.4092)	1842.500 (904.4136)	2960.144 (1736.2249)	2963.865 (909.0195)
Week 44,n=17,13,10,12,13	2051.603 (1588.9627)	1481.115 (1381.3957)	1980.733 (1444.8664)	2783.542 (1776.0608)	2954.760 (1022.5491)
Week 48,n=10,16,9,8,11	1821.325 (1139.5986)	1601.656 (1362.9717)	1562.333 (828.5650)	2859.208 (1882.7422)	3167.898 (1195.4020)
Week 52,n=11,10,6,7,6	2974.295 (2966.6259)	2418.213 (2085.2345)	2556.222 (1363.1832)	3157.054 (1988.0610)	3603.229 (1477.6777)

4. Secondary Outcome

Title	Part B: Number of Participants in Sustained Remission Over Time
Description	Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis.
Time Frame	Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	2	1	0	0
Week 4,n=1,1,1,0,0	1 2.4%	1 2.6%	1 3.8%
Week 8,n=1,0,1,0,0	1 2.4%	1 2.6%
Week 12,n=1,0,0,0,0	1 2.4%

5. Secondary Outcome

Title	Part A: Time to First Disease Flare After Clinical Remission
Description	Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only participants who achieved clinical remission were included in this analysis.

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	40	39	26	27	27
Median (Inter-Quartile Range) [Days]	NA	NA	NA	NA	NA

6. Secondary Outcome

Title	Part B: Time to First Disease Flare for Participants in Sustained Remission
Description	Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-Part B Population. Only those participants with available data at the specified time points were analyzed.

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	2	1	0	0
Median (Inter-Quartile Range) [Days]	NA	NA	NA

7. Secondary Outcome

Title	Part A: Number of Disease Flares Over Time
Description	This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented.
Time Frame	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2, n=38, 39,26,25,27	1	2	2	0	2
Week 4, n=37,37,25,23,27	3	4	3	0	2
Week 8, n=34,32,24,23,23	2	6	3	1	5
Week 12, n=32,29,24,22,22	4	9	4	4	4
Week 16, n=28,26,22,19,19	4	9	5	9	4
Week 20, n=26,23,19,18,16	4	9	6	10	3
Week 24, n=23,21,16,17,16	6	9	8	11	5
Week 28, n=19,18,12,14,14	5	8	8	11	5
Week 32, n=19,15,10,12,13	5	8	5	10	6
Week 36, n=15,13,10,12,13	3	8	5	10	6
Week 40, n=15,11,9,10,10	2	7	5	8	5
Week 44, n=11,11,6,8,9	1	8	3	6	7
Week 48, n=9,8,5,8,5	1	4	1	7	3
Week 52, n=9,5,5,5,4	1	2	1	7	4

8. Secondary Outcome

Title	Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Description	Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented.
Time Frame	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2, n=38, 39,26,25,27	0 0%	0 0%	0 0%	0 0%	0 0%
Week 4, n=37,37,25,23,27	0 0%	0 0%	0 0%	0 0%	0 0%
Week 8, n=34,32,24,23,23	0 0%	0 0%	0 0%	0 0%	0 0%
Week 12, n=32,29,24,22,22	1 2.4%	0 0%	0 0%	0 0%	0 0%
Week 16, n=28,26,22,19,19	1 2.4%	0 0%	0 0%	0 0%	0 0%
Week 20, n=26,23,19,18,16	1 2.4%	0 0%	1 3.8%	0 0%	0 0%
Week 24, n=23,21,16,17,16	1 2.4%	0 0%	1 3.8%	0 0%	0 0%
Week 28, n=19,18,12,14,14	0 0%	0 0%	1 3.8%	0 0%	0 0%
Week 32, n=19,15,10,12,13	0 0%	0 0%	0 0%	0 0%	0 0%
Week 36, n=15,13,10,12,13	0 0%	0 0%	0 0%	0 0%	0 0%
Week 40, n=15,11,9,10,10	0 0%	0 0%	0 0%	0 0%	0 0%
Week 44, n=11,11,6,8,9	0 0%	0 0%	0 0%	0 0%	0 0%
Week 48, n=9,8,5,8,5	0 0%	0 0%	0 0%	0 0%	0 0%
Week 52, n=9,5,5,5,4	0 0%	0 0%	0 0%	0 0%	0 0%

9. Secondary Outcome

Title	Part A: Number of Hospitalizations for Disease Flare Over Time
Description	Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented.
Time Frame	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2, n=38, 39,26,25,27	0	0	0	0	0
Week 4, n=37,37,25,23,27	0	0	0	0	0
Week 8, n=34,32,24,23,23	0	0	0	0	0
Week 12, n=32,29,24,22,22	2	0	0	0	0
Week 16, n=28,26,22,19,19	2	0	0	0	0
Week 20, n=26,23,19,18,16	2	0	1	0	0
Week 24, n=23,21,16,17,16	2	0	1	0	0
Week 28, n=19,18,12,14,14	0	0	1	0	0
Week 32, n=19,15,10,12,13	0	0	0	0	0
Week 36, n=15,13,10,12,13	0	0	0	0	0
Week 40, n=15,11,9,10,10	0	0	0	0	0
Week 44, n=11,11,6,8,9	0	0	0	0	0
Week 48, n=9,8,5,8,5	0	0	0	0	0
Week 52, n=9,5,5,5,4	0	0	0	0	0

10. Secondary Outcome

Title	Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
Description	SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for Physical Component Summary (PCS), Mental Component Summary (MCS) scores was presented.
Time Frame	Baseline (Week 0), Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
PCS,Baseline, n=42,38,25,23,27	49.258 (11.7655)	43.271 (12.3169)	42.919 (11.7298)	49.240 (9.2759)	45.470 (12.8498)
PCS,Week 12, n=31,28,24,22,22	51.519 (10.5352)	43.128 (11.4559)	43.655 (11.0324)	48.552 (10.4184)	47.007 (12.8749)
PCS,Week 24, n=23,20,15,17,16	50.023 (11.4731)	45.677 (12.1192)	45.097 (15.0552)	46.911 (9.2901)	44.280 (11.4740)
PCS,Week 36, n=15,13,10,12,13	51.989 (10.7521)	47.069 (12.7103)	46.005 (12.2496)	48.336 (10.0154)	44.946 (10.1921)
PCS,Week 52, n=9,5,5,5,4	50.269 (10.8743)	53.690 (7.9049)	53.608 (7.7721)	52.026 (6.4892)	53.143 (12.8351)
MCS,Week 12, n=31,28,24,22,22	43.955 (4.6164)	45.264 (5.7982)	46.393 (6.1792)	43.746 (5.3179)	43.182 (4.6707)
MCS,Week 24, n=23,20,15,17,16	44.538 (5.6952)	45.954 (5.4884)	44.877 (6.5210)	45.372 (6.4561)	45.526 (5.8924)
MCS,Week 36, n=15,13,10,12,13	45.258 (5.2429)	45.540 (4.8330)	44.550 (6.7199)	42.959 (4.8484)	46.755 (4.8284)
MCS,Week 52, n=9,5,5,5,4	44.810 (6.4757)	45.008 (2.2373)	42.004 (5.5695)	42.258 (4.1002)	42.125 (1.9020)

11. Secondary Outcome

Title	Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time
Description	EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score).
Time Frame	Baseline (Week 0) and Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Baseline, n=42,38,25,23,27	0.7918 (0.20589)	0.6681 (0.31299)	0.6912 (0.19348)	0.7429 (0.22387)	0.7554 (0.16610)
Week 12, n=31,28,24,22,22	0.7866 (0.22042)	0.7024 (0.22087)	0.7452 (0.17942)	0.7228 (0.16993)	0.7069 (0.22289)
Week 24, n=23,20,15,17,16	0.7485 (0.20310)	0.7217 (0.21397)	0.7135 (0.24006)	0.7323 (0.10346)	0.7301 (0.11498)
Week 36, n=15,13,10,12,13	0.8011 (0.13468)	0.7454 (0.22373)	0.7774 (0.11809)	0.6950 (0.15242)	0.7506 (0.17536)
Week 52, n=9,5,5,5,4	0.8210 (0.13502)	0.7628 (0.15352)	0.8092 (0.04275)	0.7864 (0.05892)	0.8068 (0.06050)

12. Secondary Outcome

Title	Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time
Description	EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score). The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'.
Time Frame	Baseline (Week 0) and Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Baseline, n=42,38,25,23,27	67.0 (17.83)	65.6 (21.43)	57.0 (17.61)	62.1 (23.81)	65.1 (16.00)
Week 12, n=31,28,24,22,22	74.3 (19.77)	64.2 (22.89)	68.4 (19.39)	63.3 (22.61)	65.5 (21.33)
Week 24, n=23,20,15,17,16	74.6 (16.26)	70.6 (24.05)	65.1 (23.11)	64.9 (19.03)	61.5 (19.71)
Week 36, n=15,13,10,12,13	79.5 (9.55)	73.9 (24.55)	66.9 (20.72)	68.3 (18.66)	61.6 (21.29)
Week 52, n=9,5,5,5,4	79.9 (9.74)	80.6 (16.50)	78.4 (14.77)	60.2 (26.33)	70.0 (27.41)

13. Secondary Outcome

Title	Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time
Description	The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Each negatively-worded item response was recoded so that 0 is a bad response and 4 is good response. All responses were added with equal weight to obtain the total score. The total score was calculated as the sum of all the individual items after recoding some of the items.
Time Frame	Baseline (Week 0), Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Baseline, n=42,38,25,23,27	38.7 (10.72)	34.2 (12.25)	31.1 (9.89)	38.0 (8.37)	34.1 (13.32)
Week 12, n=31,28,24,22,22	40.2 (8.83)	32.7 (11.25)	34.3 (11.12)	38.5 (9.82)	35.5 (13.34)
Week 24, n=23,20,15,17,16	38.1 (10.48)	36.5 (13.22)	31.2 (13.09)	36.2 (6.15)	36.0 (9.18)
Week 36, n=15,13,10,12,13	41.4 (9.41)	38.4 (9.95)	36.9 (10.88)	40.9 (6.49)	37.5 (10.02)
Week 52, n=9,5,5,5,4	42.1 (6.72)	43.0 (6.48)	40.4 (5.22)	44.0 (5.48)	41.0 (12.25)

14. Secondary Outcome

Title	Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Description	The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain on a 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Data for NRS scores over time for part A is reported.
Time Frame	Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Baseline, n=42,38,25,23,27	1.8 (2.31)	2.5 (2.97)	3.1 (2.27)	2.6 (2.09)	2.6 (2.39)
Week 2, n=38,38,25,21,27	1.3 (1.55)	2.8 (3.08)	2.8 (1.96)	2.6 (2.13)	2.6 (2.63)
Week 4, n=36,37,24,22,27	1.7 (2.16)	3.1 (3.13)	3.3 (2.20)	2.4 (2.28)	1.8 (1.72)
Week 8, n=34,30,24,21,23	1.8 (2.42)	2.9 (2.73)	3.0 (2.54)	2.1 (1.96)	3.3 (2.82)
Week 12, n=31,28,24,22,22	1.7 (2.30)	3.6 (3.05)	3.3 (2.42)	2.3 (2.50)	2.0 (2.08)
Week 16, n=27,25,22,19,19	1.4 (2.22)	3.3 (2.84)	3.0 (2.60)	2.4 (2.06)	2.7 (2.16)
Week 20, n=26,23,19,18,15	1.7 (2.27)	2.9 (2.70)	3.6 (2.63)	1.4 (1.54)	2.7 (2.02)
Week 24, n=23,20,15,17,16	2.4 (2.82)	2.5 (2.42)	3.3 (2.94)	2.4 (1.84)	3.5 (2.22)
Week 28, n=18,17,11,13,14	2.6 (2.38)	2.8 (3.03)	3.6 (2.87)	2.3 (2.14)	2.9 (2.40)
Week 32, n=19,14,9,12,12	2.1 (2.57)	1.9 (2.67)	2.9 (1.90)	2.6 (2.15)	3.1 (2.35)
Week 36, n=15,13,10,12,13	1.6 (1.88)	2.0 (2.55)	2.9 (2.02)	2.3 (2.42)	1.9 (1.93)
Week 40, n=15,11,9,10,10	2.0 (2.54)	2.0 (2.57)	3.1 (2.09)	1.9 (1.91)	2.6 (2.07)
Week 44, n=11,11,6,8,8	2.1 (2.74)	1.9 (2.47)	2.2 (1.72)	1.3 (0.71)	3.0 (2.39)
Week 48, n=9,8,5,7,5	1.9 (2.42)	0.8 (1.04)	2.6 (0.89)	1.6 (1.27)	4.0 (3.74)
Week 52, n=9,5,5,5,4	1.3 (1.66)	0.8 (0.84)	2.8 (2.28)	2.2 (0.84)	1.0 (0.82)

15. Secondary Outcome

Title	Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time
Description	Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability.
Time Frame	Baseline (Week 0) and Weeks 12, 24, 36 and 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Baseline, n=19,14,13,9,12	0.6776 (0.65658)	1.1250 (0.75479)	0.9615 (0.84376)	0.8889 (0.80875)	0.8646 (0.62034)
Week 12, n=12,8,12,9,9	0.3229 (0.41785)	1.0938 (0.91063)	0.7292 (0.87392)	0.5694 (0.54526)	0.9306 (0.66764)
Week 24, n=10, 7,7,7,9	0.5875 (0.58940)	0.8750 (0.78395)	0.9821 (0.92823)	0.9107 (0.83452)	0.9583 (0.70986)
Week 36, n=6,5,4,4,7	0.5208 (0.70007)	0.8250 (0.80816)	0.6250 (0.51031)	0.5625 (0.58184)	1.0000 (0.91287)
Week 52, n=5,2,3,1,2	0.3000 (0.41079)	0.3125 (0.44194)	0.1667 (0.14434)	0.0000 (NA)	0.1875 (0.26517)

16. Secondary Outcome

Title	Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Description	Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
Time Frame	Weeks 12, 24 and 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 12,Much Better, n=31,28,24,22,22	11 26.2%	7 17.9%	2 7.7%	5 18.5%	5 18.5%
Week 12,Better, n=31,28,24,22,22	11 26.2%	10 25.6%	11 42.3%	4 14.8%	11 40.7%
Week 12, Slightly Better, n=31,28,24,22,22	3 7.1%	5 12.8%	4 15.4%	8 29.6%	3 11.1%
Week 12,No Change, n=31,28,24,22,22	3 7.1%	3 7.7%	4 15.4%	0 0%	3 11.1%
Week 12,Slightly Worse, n=31,28,24,22,22	1 2.4%	1 2.6%	2 7.7%	4 14.8%	0 0%
Week 12,Worse, n=31,28,24,22,22	2 4.8%	2 5.1%	1 3.8%	1 3.7%	0 0%
Week 12,Much Worse, n=31,28,24,22,22	0 0%	0 0%	0 0%	0 0%	0 0%
Week 24,Much Better, n=23,20,15,17,16	11 26.2%	6 15.4%	6 23.1%	5 18.5%	6 22.2%
Week 24,Better, n=23,20,15,17,16	7 16.7%	8 20.5%	4 15.4%	6 22.2%	6 22.2%
Week 24, Slightly Better,n=23,20,15,17,16	2 4.8%	2 5.1%	0 0%	4 14.8%	1 3.7%
Week 24,No Change, n=23,20,15,17,16	1 2.4%	2 5.1%	2 7.7%	1 3.7%	1 3.7%
Week 24,Slightly Worse, n=23,20,15,17,16	2 4.8%	1 2.6%	2 7.7%	1 3.7%	1 3.7%
Week 24, Worse,n=23,20,15,17,16	0 0%	1 2.6%	1 3.8%	0 0%	1 3.7%
Week 24, Much Worse,n=23,20,15,17,16	0 0%	0 0%	0 0%	0 0%	0 0%
Week 52,Much Better, n=9,5,5,5,4	6 14.3%	3 7.7%	3 11.5%	2 7.4%	3 11.1%
Week 52,Better, n=9,5,5,5,4	2 4.8%	2 5.1%	1 3.8%	2 7.4%	0 0%
Week 52,Slightly Better, n=9,5,5,5,4	0 0%	0 0%	1 3.8%	1 3.7%	1 3.7%
Week 52,No Change, n=9,5,5,5,4	1 2.4%	0 0%	0 0%	0 0%	0 0%
Week 52,Slightly Worse, n=9,5,5,5,4	0 0%	0 0%	0 0%	0 0%	0 0%
Week 52,Worse, n=9,5,5,5,4	0 0%	0 0%	0 0%	0 0%	0 0%
Week 52,Much Worse, n=9,5,5,5,4	0 0%	0 0%	0 0%	0 0%	0 0%

17. Secondary Outcome

Title	Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Description	The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS) of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor").
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Baseline, n=42,39,25,26,27	2.96 (2.148)	3.72 (2.649)	4.24 (2.049)	3.60 (2.133)	3.64 (2.732)
Week 2, n=38,38,25,21,27	2.59 (1.923)	3.51 (2.389)	3.73 (1.911)	3.45 (2.247)	3.52 (2.177)
Week 4, n=36,37,24,22,27	2.43 (2.138)	3.75 (2.770)	3.81 (1.737)	3.01 (1.997)	2.62 (1.762)
Week 8, n=34,30,24,21,23	1.97 (2.076)	3.87 (2.322)	3.44 (1.763)	2.85 (1.769)	2.90 (2.230)
Week 12, n=31,28,24,22,22	1.97 (1.567)	3.80 (2.557)	3.95 (2.200)	3.20 (2.340)	2.75 (2.056)
Week 16, n=27,25,22,19,19	1.95 (2.237)	3.82 (2.615)	3.39 (2.523)	2.86 (1.809)	2.76 (1.777)
Week 20, n=26,23,19,18,15	2.60 (2.089)	3.20 (2.663)	4.17 (2.334)	2.45 (1.697)	2.90 (1.869)
Week 24, n=23,20,15,17,16	2.63 (2.140)	2.33 (1.975)	3.83 (2.447)	2.85 (2.256)	3.34 (1.791)
Week 28, n=18,17,11,13,14	2.44 (2.094)	3.09 (2.915)	4.18 (2.169)	2.68 (2.106)	2.74 (1.791)
Week 32, n=19,14,9,12,12	2.01 (1.781)	2.22 (2.564)	3.02 (1.199)	2.43 (2.385)	2.88 (2.541)
Week 36, n=15,13,10,12,13	1.46 (1.253)	2.66 (2.982)	2.79 (2.013)	2.68 (2.490)	2.62 (1.990)
Week 40, n=15,11,9,10,10	2.05 (1.809)	2.35 (2.495)	3.20 (2.329)	2.24 (1.883)	3.00 (2.658)
Week 44, n=11,11,6,8,8	2.28 (2.872)	2.19 (2.429)	2.17 (1.824)	2.18 (1.835)	3.49 (2.322)
Week 48, n=9,8,5,7,5	1.81 (1.934)	1.03 (1.253)	2.30 (1.515)	1.86 (1.586)	4.48 (3.545)
Week 52, n=9,5,5,5,4	1.10 (0.857)	0.46 (0.358)	2.76 (2.668)	2.44 (1.716)	2.13 (2.651)

18. Secondary Outcome

Title	Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Description	The Physician's Global Assessments of Disease Activity was recorded on a VAS of 10 cm ranging from 0 ("none") to 10 ("extremely active").
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Baseline, n=42,39,25,26,27	2.33 (2.101)	2.95 (2.208)	2.94 (2.374)	3.05 (2.501)	3.25 (2.823)
Week 2, n=36,35,25,20,26	1.09 (1.373)	1.52 (1.822)	1.83 (1.558)	1.85 (1.879)	1.76 (2.094)
Week 4, n=33,32,23,21,25	0.81 (1.191)	1.44 (1.904)	1.55 (1.236)	0.92 (1.125)	1.02 (1.090)
Week 8, n=33,28,23,20,21	1.09 (1.508)	1.30 (1.723)	1.35 (1.229)	0.79 (0.798)	1.14 (1.226)
Week 12, n=29,25,23,18,21	1.08 (1.486)	1.81 (2.183)	1.64 (1.908)	1.28 (1.629)	1.47 (2.151)
Week 16, n=26,23,21,16,19	0.74 (0.895)	1.54 (1.793)	1.87 (2.078)	1.39 (1.830)	0.67 (0.779)
Week 20, n=25,23,18,17,15	0.71 (1.189)	1.42 (1.808)	1.16 (1.628)	0.83 (0.882)	1.27 (1.622)
Week 24, n=20,20,15,15,15	0.82 (1.089)	0.68 (0.869)	1.50 (1.690)	1.48 (2.003)	1.37 (1.551)
Week 28, n=17,17,11,12,13	0.76 (1.068)	1.43 (1.986)	1.18 (2.116)	0.88 (0.586)	0.85 (1.440)
Week 32, n=19,14,8,11,12	0.83 (1.320)	0.67 (0.841)	1.40 (1.516)	1.26 (1.546)	0.89 (1.672)
Week 36, n=13,11,10,11,13	0.48 (0.660)	1.12 (1.589)	0.61 (0.792)	0.56 (0.408)	0.75 (0.906)
Week 40, n=13,9,8,9,10	0.38 (0.395)	0.77 (1.417)	0.36 (0.283)	0.52 (0.531)	0.57 (0.566)
Week 44, n=10,9,6,8,7	0.31 (0.228)	1.07 (1.574)	0.43 (0.547)	0.58 (0.740)	0.87 (1.404)
Week 48, n=7,7,5,6,5	0.27 (0.446)	0.31 (0.540)	0.30 (0.316)	0.78 (1.482)	1.60 (2.164)
Week 52, n=9,5,5,4,4	0.31 (0.434)	0.10 (0.141)	0.32 (0.311)	1.35 (0.947)	1.80 (3.082)

19. Secondary Outcome

Title	Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Description	Blood samples were collected for analysis of CRP. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in serum CRP over time for part A was reported. The Safety set comprised of all randomized participants who received at least 1 dose of SC IP.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2,n=38,39,26,24,26	-5.07 (6.616)	-8.81 (22.954)	-5.15 (8.436)	1.27 (13.155)	1.07 (6.794)
Week 4,n=37,38,25,23,27	-4.39 (6.384)	-9.01 (23.327)	-4.09 (7.169)	4.91 (10.503)	0.76 (5.511)
Week 8,n=34,31,24,22,23	-4.98 (6.583)	-9.94 (25.685)	-4.19 (7.197)	10.00 (14.652)	7.86 (25.894)
Week 12,n=32,28,24,21,21	-5.08 (6.690)	-9.96 (26.849)	-4.22 (7.335)	14.81 (18.082)	4.04 (9.339)
Week 16,n=28,26,22,19,18	-4.35 (5.648)	-10.43 (27.765)	-4.48 (7.621)	10.53 (17.303)	6.99 (15.503)
Week 20,n=26,23,19,18,16	-4.50 (5.876)	-11.67 (29.422)	-4.78 (8.100)	5.32 (14.506)	2.35 (7.840)
Week 24,n=23,20,16,17,16	-4.38 (4.640)	-13.19 (31.269)	-5.14 (8.837)	5.07 (13.815)	6.54 (20.711)
Week 28,n=19,18,12,14,14	-5.28 (6.498)	-13.42 (33.182)	-6.33 (10.022)	1.87 (10.926)	0.22 (11.318)
Week 32,n=19,15,10,12,13	-4.85 (7.259)	-14.47 (36.343)	-7.15 (10.875)	2.61 (9.835)	4.37 (16.277)
Week 36,n=15,12,10,12,13	-4.72 (4.473)	-16.28 (40.531)	-7.08 (10.874)	5.73 (19.040)	1.64 (10.418)
Week 40,n=15,11,8,10,10	-4.72 (4.374)	-17.67 (42.240)	-4.69 (8.510)	6.27 (21.164)	2.77 (13.101)
Week 44,n=11,11,6,8,9	-5.35 (4.523)	-17.47 (42.350)	-1.90 (1.456)	2.80 (20.439)	5.13 (7.292)
Week 48,n=9,7,5,8,5	-5.91 (4.993)	-23.39 (52.962)	-2.20 (1.562)	6.31 (20.952)	8.10 (18.084)
Week 52,n=9,5,5,5,4	-6.00 (4.663)	-7.26 (9.461)	-2.20 (1.575)	0.64 (9.453)	-1.65 (4.561)

20. Secondary Outcome

Title	Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Description	Blood samples were collected for analysis of ESR. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in ESR over time for part A was reported.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2,n=37,39,26,24,26	-13.05 (9.885)	-12.78 (15.560)	-14.62 (16.500)	-1.33 (9.323)	-9.96 (20.142)
Week 4,n=36,38,25,22,27	-12.83 (9.346)	-17.41 (15.867)	-14.13 (12.419)	7.59 (15.308)	-5.30 (22.250)
Week 8,n=33,31,24,22,23	-14.21 (9.927)	-18.76 (17.727)	-15.05 (14.030)	6.41 (12.105)	1.78 (27.361)
Week 12,n=32,28,24,22,22	-14.97 (11.361)	-17.89 (17.846)	-14.30 (13.271)	20.36 (18.017)	-2.55 (21.498)
Week 16,n=28,26,22,19,19	-12.50 (10.469)	-17.17 (17.693)	-15.37 (13.956)	14.21 (25.189)	-2.53 (20.839)
Week 20,n=26,23,18,18,16	-13.19 (9.600)	-17.07 (18.498)	-14.33 (15.442)	10.00 (22.141)	-5.81 (23.063)
Week 24,n=23,19,16,17,16	-13.63 (11.209)	-16.84 (15.378)	-14.89 (14.504)	7.59 (21.567)	-3.06 (22.389)
Week 28,n=19,18,11,14,14	-15.26 (12.274)	-19.94 (20.069)	-16.84 (16.856)	1.50 (15.854)	-1.71 (29.148)
Week 32,n=19,15,10,12,13	-13.26 (17.486)	-19.80 (19.266)	-14.52 (13.630)	-2.42 (20.129)	-2.85 (29.493)
Week 36,n=15,12,10,12, 13	-14.47 (11.673)	-21.25 (20.855)	-14.42 (13.482)	0.67 (19.009)	0.92 (28.324)
Week 40,n=15,11,9,10,10	-14.40 (12.070)	-22.27 (21.873)	-11.24 (13.277)	9.80 (28.840)	-2.60 (27.818)
Week 44,n=11,11,6,8,8	-12.64 (10.347)	-22.18 (21.409)	-12.00 (13.520)	4.88 (18.256)	2.88 (21.860)
Week 48,n=9,8,5,8,5	-15.33 (11.822)	-25.63 (24.372)	-14.00 (14.335)	4.50 (24.308)	8.60 (25.205)
Week 52,n=9,5,5,5,4	-14.78 (11.692)	-24.60 (17.700)	-12.80 (15.385)	-4.60 (10.431)	1.25 (15.042)

21. Secondary Outcome

Title	Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs have been reported.
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Any AE	41 97.6%	36 92.3%	25 96.2%	26 96.3%	24 88.9%
Any SAE	8 19%	6 15.4%	6 23.1%	5 18.5%	6 22.2%
Any Corticosteroid related AE	18 42.9%	21 53.8%	15 57.7%	13 48.1%	12 44.4%

22. Secondary Outcome

Title	Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Description	SBP and DBP were measured in semi-supine position after 5 minutes rest at indicated time points. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)..

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
SBP,Week 2,n=37,39,26,24,27	-0.9 (13.11)	3.5 (13.97)	-2.1 (17.19)	5.7 (12.67)	-0.9 (15.63)
SBP,Week 4,n=37,37,25,23,27	-0.9 (15.17)	0.2 (15.99)	-4.7 (15.00)	-2.2 (14.60)	-3.4 (14.25)
SBP,Week 8,n=34,32,24,22,23	0.3 (14.33)	-3.9 (17.17)	-3.5 (15.73)	-0.8 (18.94)	-8.3 (21.05)
SBP,Week 12,n=32,29,24,22,22	-2.3 (15.19)	-2.4 (17.15)	-6.2 (13.45)	1.4 (12.97)	-6.1 (19.31)
SBP,Week 16,n=28,26,22,19,19	-6.0 (15.39)	-5.1 (18.28)	-3.0 (20.22)	1.9 (17.51)	-6.4 (12.73)
SBP,Week 20,n=26,23,19,18,16	-6.7 (10.73)	-0.7 (14.09)	-3.4 (15.39)	-1.7 (17.16)	-9.4 (21.44)
SBP,Week 24,n=23,21,16,17,16	-5.2 (12.65)	-2.5 (15.46)	-5.6 (16.55)	-2.6 (18.75)	-8.6 (15.65)
SBP,Week 28,n=19,18,12,14,14	-8.8 (12.87)	-4.2 (20.49)	-0.1 (14.76)	6.4 (19.31)	-2.6 (17.71)
SBP,Week 32,n=19,15,10,12,13	-10.7 (13.96)	-3.7 (15.03)	-7.4 (11.80)	3.4 (14.99)	-8.8 (14.80)
SBP,Week 36,n=15,13,10,12,13	-6.2 (13.92)	-8.0 (15.80)	-6.8 (12.10)	-0.6 (20.46)	-2.5 (16.13)
SBP,Week 40,n=15,11,9,10,10	-11.9 (11.75)	0.9 (13.14)	-4.8 (14.17)	2.1 (19.31)	-7.4 (20.14)
SBP,Week 44,n=11,11,6,8,9	-12.7 (17.66)	-4.2 (19.22)	2.7 (13.26)	2.9 (15.99)	1.8 (13.91)
SBP,Week 48,n=9,8,5,8,5	-13.6 (11.85)	-0.4 (9.44)	-3.6 (28.13)	8.8 (14.15)	4.8 (15.51)
SBP,Week 52,n=9,5,5,5,4	-8.1 (15.85)	1.2 (14.46)	2.2 (19.52)	2.2 (18.46)	-3.8 (12.34)
DBP,Week 2,n=37,39,26,24,27	0.3 (7.41)	1.2 (10.05)	-2.3 (14.00)	2.4 (9.85)	-2.2 (9.22)
DBP,Week 4,n=37,37,25,23,27	1.8 (8.85)	1.5 (10.24)	-4.1 (13.22)	0.1 (11.66)	-3.0 (10.22)
DBP,Week 8,n=34,32,24,22,23	2.1 (8.47)	-1.3 (7.62)	-4.0 (12.26)	2.6 (11.27)	-5.6 (11.83)
DBP,Week 12,n=32,29,24,22,22	1.0 (9.60)	2.0 (12.35)	-4.7 (12.14)	1.3 (10.58)	-2.5 (11.16)
DBP,Week 16,n=28,26,22,19,19	0.2 (7.48)	-2.5 (11.58)	-3.1 (12.80)	-1.3 (10.64)	-3.4 (7.97)
DBP,Week 20,n=26,23,19,18,16	-0.9 (7.66)	1.4 (12.47)	-3.2 (16.21)	-2.0 (9.06)	-2.1 (10.98)
DBP,Week 24,n=23,21,16,17,16	1.3 (8.72)	-0.6 (12.85)	-2.7 (11.77)	-3.3 (10.21)	-3.1 (9.27)
DBP,Week 28,n=19,18,12,14,14	-3.1 (9.39)	-2.2 (10.05)	-4.3 (15.80)	0.1 (13.87)	-1.9 (10.37)
DBP,Week 32,n=19,15,10,12,13	-4.2 (7.50)	-2.3 (12.92)	-6.9 (25.47)	-1.2 (11.17)	-5.8 (9.09)
DBP,Week 36,n=15,13,10,12,13	-0.6 (8.92)	-5.1 (9.89)	-5.6 (17.02)	-1.2 (13.31)	-2.7 (13.05)
DBP,Week 40,n=15,11,9,10,10	-6.9 (12.41)	2.6 (11.88)	-8.0 (21.60)	-2.0 (14.07)	-6.1 (11.97)
DBP,Week 44,n=11,11,6,8,9	-2.7 (12.10)	-6.5 (14.56)	-2.5 (23.89)	-1.5 (8.28)	1.3 (11.36)
DBP,Week 48,n=9,8,5,8,5	-5.6 (11.79)	-2.3 (11.42)	-2.0 (16.00)	-3.4 (12.75)	0.6 (8.47)
DBP,Week 52,n=9,5,5,5,4	0.2 (12.55)	1.8 (10.23)	2.2 (3.35)	1.4 (11.89)	0.5 (5.92)

23. Secondary Outcome

Title	Part A: Change From Baseline in Pulse Rate
Description	Pulse rate was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2, ,n=37,39,25,24,27	-1.9 (8.07)	-2.1 (8.93)	1.8 (10.40)	-0.4 (12.34)	-1.6 (9.79)
Week 4,n=37,37,25,22,27	0.2 (8.82)	-1.4 (8.94)	-2.4 (9.42)	2.2 (13.39)	-1.9 (10.33)
Week 8,n=34,32,24,22,23	-1.1 (10.23)	-3.2 (11.42)	-3.1 (8.80)	4.3 (12.36)	0.5 (11.06)
Week 12,n=32,29,23,22,22	-3.8 (8.50)	-1.2 (13.62)	-0.8 (8.35)	4.5 (14.54)	-2.7 (10.95)
Week 16,n=28,26,22,19,19	-3.4 (10.79)	0.3 (9.06)	-5.3 (10.32)	0.3 (15.04)	-2.2 (10.76)
Week 20,n=26,23,19,18,16	-3.0 (9.75)	0.2 (11.35)	-0.7 (12.62)	1.0 (13.76)	-4.0 (12.54)
Week 24,n=23,21,16,17,16	-2.1 (9.29)	-3.5 (11.18)	0.7 (14.13)	0.1 (12.76)	2.7 (8.27)
Week 28,n=19,18,12,14,14	-1.4 (10.33)	-1.2 (9.21)	-3.5 (13.26)	0.1 (13.24)	0.5 (10.60)
Week 32,n=19,15,10,12,13	-1.3 (8.20)	-4.7 (8.50)	-2.2 (10.78)	-0.8 (16.10)	-0.6 (12.58)
Week 36,n=15,13,10,12,13	-5.9 (9.79)	-5.1 (9.06)	-4.5 (9.12)	-0.5 (12.22)	-3.2 (9.83)
Week 40,n=15,11,9,10,10	-3.9 (5.64)	-3.0 (11.93)	-3.4 (10.57)	3.3 (12.83)	-3.8 (14.09)
Week 44,n=11,11,6,8,9	-7.1 (8.01)	-3.4 (15.86)	-8.3 (13.41)	4.3 (15.34)	-3.4 (8.57)
Week 48,n=9,8,5,8,5	-8.2 (7.36)	-9.3 (8.76)	-7.2 (10.47)	-1.9 (11.47)	0.0 (16.72)
Week 52,n=9,5,5,5,4	-5.0 (12.97)	-11.0 (3.74)	-4.0 (15.89)	6.8 (6.34)	-5.3 (12.04)

24. Secondary Outcome

Title	Part A: Change From Baseline in Temperature
Description	Temperature was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2, ,n=37,39,26,24,27	-0.11 (0.269)	-0.04 (0.336)	0.03 (0.433)	-0.16 (0.421)	0.10 (0.449)
Week 4,n=37,37,25,23,27	-0.12 (0.345)	0.01 (0.407)	0.04 (0.399)	-0.10 (0.387)	0.11 (0.340)
Week 8,n=34,32,23,22,23	-0.04 (0.400)	-0.09 (0.432)	-0.07 (0.553)	0.04 (0.579)	0.19 (0.425)
Week 12,n=32,29,24,22,22	-0.08 (0.461)	-0.11 (0.367)	0.01 (0.444)	-0.15 (0.494)	0.09 (0.450)
Week 16,n=28,26,22,19,19	-0.08 (0.313)	-0.05 (0.392)	0.04 (0.316)	-0.21 (0.664)	0.09 (0.317)
Week 20,n=26,23,19,18,16	0.03 (0.428)	-0.05 (0.483)	-0.12 (0.651)	-0.07 (0.355)	0.05 (0.395)
Week 24,n=23,21,16,17,16	0.03 (0.389)	-0.11 (0.255)	-0.11 (0.558)	-0.26 (0.476)	0.04 (0.441)
Week 28,n=19,18,12,13,14	0.03 (0.444)	-0.07 (0.517)	-0.09 (0.683)	-0.16 (0.479)	-0.06 (0.282)
Week 32,n=19,15,10,12,13	-0.01 (0.515)	-0.07 (0.349)	0.28 (0.418)	-0.13 (0.367)	0.01 (0.364)
Week 36,n=15,13,9,12,13	-0.09 (0.406)	-0.11 (0.569)	-0.10 (0.391)	-0.09 (0.390)	-0.08 (0.367)
Week 40,n=15,11,9,10,10	0.08 (0.426)	-0.03 (0.454)	0.18 (0.438)	-0.05 (0.334)	-0.05 (0.306)
Week 44,n=11,11,6,8,9	-0.14 (0.347)	-0.06 (0.391)	-0.03 (0.314)	0.00 (0.438)	-0.08 (0.396)
Week 48,n=9,8,5,8,5	-0.22 (0.233)	-0.05 (0.510)	-0.14 (0.498)	-0.01 (0.280)	-0.08 (0.559)
Week 52,n=9,5,5,5,4	-0.08 (0.291)	-0.32 (0.286)	0.14 (0.230)	0.02 (0.409)	-0.08 (0.814)

25. Secondary Outcome

Title	Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Description	Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Eosinophils,Week 2,n=37,36,24,23,25	0.019 (0.0543)	0.001 (0.0690)	0.010 (0.0433)	0.015 (0.0557)	0.062 (0.2084)
Eosinophils,Week 4,n=36,37,24,22,26	0.043 (0.0934)	0.035 (0.1238)	0.012 (0.0719)	0.023 (0.0617)	0.030 (0.1164)
Eosinophils,Week 8,n=34,29,22,22,21	0.056 (0.0959)	0.102 (0.1634)	0.054 (0.1036)	0.048 (0.1498)	0.010 (0.0591)
Eosinophils,Week 12,n=31,28,23,22,22	0.077 (0.1128)	0.155 (0.1971)	0.090 (0.0860)	0.090 (0.1684)	0.030 (0.0548)
Eosinophils,Week 16,n=27,26,20,19,19	0.097 (0.1307)	0.162 (0.2170)	0.117 (0.1772)	0.067 (0.1148)	0.067 (0.1746)
Eosinophils,Week 20,n=25,22,18,17,16	0.166 (0.2073)	0.114 (0.2085)	0.136 (0.1518)	0.094 (0.1743)	0.057 (0.0637)
Eosinophils,Week 24,n=22,21,16,16,16	0.210 (0.4418)	0.109 (0.1590)	0.109 (0.1094)	0.089 (0.2392)	0.051 (0.0676)
Eosinophils,Week 28,n=18,18,11,14,13	0.163 (0.2562)	0.068 (0.1340)	0.120 (0.1340)	0.046 (0.0714)	0.051 (0.0538)
Eosinophils,Week 32,n=19,15,10,12,13	0.244 (0.3707)	0.069 (0.1580)	0.092 (0.1253)	0.038 (0.0597)	0.056 (0.0733)
Eosinophils,Week 36,n=15,12,10,12,12	0.282 (0.3117)	0.076 (0.1753)	0.153 (0.1166)	0.049 (0.0720)	0.059 (0.0585)
Eosinophils,Week 40,n=14,11,8,10,10	0.191 (0.2175)	0.075 (0.1924)	0.104 (0.1161)	0.065 (0.0737)	0.071 (0.1140)
Eosinophils,Week 44,n=11,10,6,7,9	0.144 (0.1952)	0.045 (0.1329)	0.165 (0.1564)	0.024 (0.0541)	0.066 (0.0600)
Eosinophils,Week 48,n=9,8,4,8,5	0.091 (0.0664)	0.059 (0.1561)	0.233 (0.2387)	0.028 (0.0489)	0.030 (0.0604)
Eosinophils,Week 52,n=8,5,5,5,4	0.151 (0.1865)	0.192 (0.1839)	0.172 (0.1207)	0.108 (0.1139)	0.013 (0.0802)
Leukocytes,Week 2,n=37,38,24,24,25	-3.12 (2.268)	-3.63 (1.971)	-3.32 (2.816)	-0.76 (2.145)	0.34 (2.238)
Leukocytes,Week 4,n=36,37,24,22,26	-3.66 (2.621)	-4.76 (2.411)	-4.07 (2.157)	-1.64 (2.247)	-0.16 (2.330)
Leukocytes,Week 8,n=34,29,23,22,21	-4.04 (2.481)	-5.65 (3.672)	-4.42 (2.469)	-1.79 (2.682)	-0.26 (1.880)
Leukocytes,Week 12,n=31,28,23,22,22	-4.68 (2.666)	-5.67 (2.551)	-5.23 (2.581)	-2.66 (2.883)	-1.28 (1.810)
Leukocytes,Week 16,n=27,26,20,19,19	-5.21 (2.244)	-5.61 (3.502)	-5.36 (2.309)	-2.98 (3.018)	-0.79 (3.018)
Leukocytes,Week 20,n=25,23,18,18,16	-5.24 (1.950)	-5.20 (3.104)	-5.40 (2.414)	-3.24 (3.592)	-1.71 (2.840)
Leukocytes,Week 24,n=22,21,16,16,16	-5.14 (3.559)	-6.39 (2.952)	-5.01 (1.884)	-2.89 (3.892)	-1.52 (2.738)
Leukocytes,Week 28,n=18,18,12,14,13	-5.46 (2.619)	-6.04 (3.274)	-4.58 (2.143)	-3.01 (3.368)	-1.97 (3.461)
Leukocytes,Week 32,n=19,15,10,12,13	-5.71 (2.419)	-5.61 (3.250)	-5.27 (1.696)	-3.43 (3.342)	-2.33 (3.011)
Leukocytes,Week 36,n=15,12,10,12,12	-5.76 (2.106)	-6.82 (2.814)	-5.58 (1.757)	-3.36 (3.612)	-2.95 (3.635)
Leukocytes,Week 40,n=14,11,8,10,10	-6.14 (1.987)	-7.10 (2.534)	-6.46 (2.130)	-3.18 (3.662)	-2.23 (3.142)
Leukocytes,Week 44,n=11,10,6,7,9	-6.25 (2.300)	-6.95 (2.441)	-6.17 (1.726)	-2.83 (3.875)	-3.08 (3.056)
Leukocytes,Week 48,n=9,8,4,8,5	-6.88 (2.436)	-7.35 (2.853)	-6.48 (2.887)	-2.69 (2.979)	-3.00 (3.045)
Leukocytes,Week 52,n=8,5,5,5,4	-6.66 (2.654)	-7.36 (2.920)	-6.38 (2.262)	-3.84 (3.467)	-3.10 (4.090)
Lymphocytes,Week 2,n=37,36,24,23,25	0.015 (1.1645)	0.002 (1.2620)	-0.041 (1.3241)	-0.159 (0.9064)	-0.209 (0.9381)
Lymphocytes,Week 4,n=36,37,24,22,26	0.027 (1.2460)	-0.255 (1.2225)	0.057 (1.2338)	-0.002 (0.7340)	-0.382 (1.0808)
Lymphocytes,Week 8,n=34,29,22,22,21	-0.191 (1.3361)	-0.411 (1.2086)	-0.067 (1.2814)	-0.049 (1.0832)	-0.516 (0.8562)
Lymphocytes,Week 12,n=31,28,23,22,22	-0.215 (1.3052)	-0.437 (1.2479)	-0.081 (1.2018)	-0.128 (1.0505)	-0.344 (0.7846)
Lymphocytes,Week 16,n=27,26,20,19,19	-0.450 (1.3450)	-0.704 (1.2994)	-0.153 (0.7804)	-0.327 (1.4269)	-0.635 (0.8037)
Lymphocytes,Week 20,n=25,22,18,17,16	-0.616 (1.2793)	-0.313 (1.3011)	-0.439 (1.4363)	-0.385 (0.8819)	-0.533 (0.7432)
Lymphocytes,Week 24,n=22,21,16,16,16	-0.399 (1.4276)	-0.179 (1.8386)	-0.073 (0.7890)	-0.401 (1.2030)	-0.386 (0.7504)
Lymphocytes,Week 28,n=18,18,11,14,13	-0.614 (1.5450)	-0.273 (1.3296)	-0.192 (0.7271)	-0.258 (1.0211)	-0.565 (1.0397)
Lymphocytes,Week 32,n=19,15,10,12,13	-0.602 (1.3438)	-0.407 (1.4002)	-0.476 (0.7997)	-0.402 (1.2625)	-0.492 (0.7877)
Lymphocytes,Week 36,n=15,12,10,12,12	-0.625 (1.5738)	-0.672 (1.2263)	-0.430 (0.7690)	-0.417 (1.0538)	-0.078 (0.7182)
Lymphocytes,Week 40,n=14,11,8,10,10	-0.929 (1.5351)	-0.845 (1.3603)	-0.570 (0.8261)	-0.519 (1.1491)	-0.681 (0.7363)
Lymphocytes,Week 44,n=11,10,6,7,9	-0.915 (1.2235)	-1.047 (1.3375)	-0.198 (0.9783)	-1.029 (1.0293)	-0.343 (0.8113)
Lymphocytes,Week 48,n=9,8,4,8,5	-1.258 (1.2063)	-0.923 (1.4811)	0.118 (1.0588)	-0.576 (1.1994)	-0.510 (1.1450)
Lymphocytes,Week 52,n=8,5,5,5,4	-1.253 (1.2857)	-0.754 (1.0291)	-0.286 (1.0455)	0.194 (0.8800)	-0.128 (1.2618)
Neutrophils,Week 2,n=37,36,24,23,25	-3.208 (2.5761)	-3.454 (2.2265)	-3.367 (2.5781)	-0.748 (2.2688)	0.387 (2.6156)
Neutrophils,Week 4,n=36,37,24,22,26	-3.791 (2.5242)	-4.476 (2.3632)	-4.106 (2.4354)	-1.673 (1.9745)	0.089 (3.1611)
Neutrophils,Week 8,n=34,29,22,22,21	-3.949 (2.5477)	-5.271 (3.2214)	-4.354 (2.4128)	-1.869 (3.2525)	0.192 (2.2180)
Neutrophils,Week 12,n=31,28,23,22,22	-4.590 (2.6603)	-5.340 (2.6437)	-5.250 (2.1872)	-2.678 (3.1106)	-1.019 (2.1306)
Neutrophils,Week 16,n=27,26,20,19,19	-4.933 (2.4430)	-4.929 (3.7907)	-5.358 (2.2367)	-2.766 (3.3212)	-0.263 (3.3610)
Neutrophils,Week 20,n=25,22,18,17,16	-4.867 (2.3110)	-4.997 (3.0763)	-5.168 (2.4898)	-2.856 (4.0311)	-1.355 (3.3883)
Neutrophils,Week 24,n=22,21,16,16,16	-4.985 (3.5051)	-6.257 (2.7551)	-5.030 (1.9579)	-2.570 (4.2089)	-1.342 (3.1038)
Neutrophils,Week 28,n=18,18,11,14,13	-5.076 (2.3415)	-5.729 (3.1699)	-4.469 (2.1333)	-2.764 (3.5787)	-1.503 (4.3502)
Neutrophils,Week 32,n=19,15,10,12,13	-5.357 (2.5525)	-5.153 (3.1939)	-4.840 (1.9387)	-3.006 (3.7915)	-2.018 (3.5674)
Neutrophils,Week 36,n=15,12,10,12,12	-5.444 (2.1894)	-6.079 (3.0406)	-5.265 (1.8375)	-3.023 (3.9443)	-3.018 (4.1223)
Neutrophils,Week 40,n=14,11,8,10,10	-5.416 (2.4371)	-6.179 (2.8859)	-5.916 (1.7172)	-2.705 (3.4469)	-1.663 (3.4090)
Neutrophils,Week 44,n=11,10,6,7,9	-5.432 (2.5555)	-5.799 (3.1785)	-6.185 (1.3944)	-1.807 (4.5472)	-2.883 (3.8690)
Neutrophils,Week 48,n=9,8,4,8,5	-5.628 (2.3471)	-6.396 (3.4832)	-6.790 (1.6060)	-2.160 (3.3843)	-2.650 (4.0017)
Neutrophils,Week 52,n=8,5,5,5,4	-5.520 (2.7316)	-6.774 (2.6817)	-6.256 (1.8929)	-4.214 (3.6948)	-2.990 (4.8629)
Platelets,Week 2,n=37,38,24,23,25	-39.0 (39.46)	-49.2 (52.77)	-41.1 (40.29)	-1.9 (37.57)	-4.3 (49.32)
Platelets,Week 4,n=36,37,24,22,26	-45.9 (41.70)	-64.3 (56.21)	-49.0 (35.74)	2.1 (41.23)	-5.7 (43.51)
Platelets,Week 8,n=34,29,22,22,21	-37.3 (31.22)	-72.2 (75.77)	-53.3 (37.10)	14.2 (45.62)	15.7 (57.21)
Platelets,Week 12,n=31,28,23,22,22	-51.2 (33.25)	-74.0 (52.17)	-55.4 (38.89)	17.8 (50.58)	4.3 (55.14)
Platelets,Week 16,n=27,26,20,19,19	-53.8 (33.54)	-69.9 (53.79)	-54.8 (39.71)	12.4 (52.98)	13.8 (60.11)
Platelets,Week 20,n=25,22,18,17,16	-52.2 (54.64)	-69.5 (58.27)	-53.5 (38.00)	14.8 (44.55)	-0.1 (56.21)
Platelets,Week 24,n=22,21,16,16,16	-58.0 (39.58)	-72.4 (64.56)	-57.5 (44.46)	6.3 (46.94)	20.1 (45.30)
Platelets,Week 28,n=18,18,11,14,13	-70.2 (45.09)	-61.3 (54.34)	-50.6 (27.71)	15.4 (31.84)	13.1 (47.56)
Platelets,Week 32,n=19,15,10,12,13	-57.6 (66.52)	-65.5 (51.20)	-50.8 (33.70)	-1.5 (45.26)	10.7 (53.95)
Platelets,Week 36,n=15,12,10,12,12	-74.1 (32.84)	-70.6 (58.49)	-48.6 (23.64)	13.4 (32.69)	20.0 (85.28)
Platelets,Week 40,n=14,11,8,10,10	-77.4 (41.72)	-66.9 (62.21)	-42.0 (21.33)	5.6 (45.38)	5.3 (54.71)
Platelets,Week 44,n=11,10,6,7,9	-69.5 (36.62)	-76.7 (64.91)	-58.2 (19.28)	11.1 (48.18)	-3.3 (56.78)
Platelets,Week 48,n=9,8,4,8,5	-68.3 (41.94)	-71.4 (57.71)	-80.8 (22.98)	14.4 (53.59)	0.4 (61.59)
Platelets,Week 52,n=8,5,5,5,4	-81.9 (38.36)	-51.6 (43.90)	-58.6 (40.79)	-18.6 (55.44)	-17.5 (38.04)

26. Secondary Outcome

Title	Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Description	Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
MCHC,Week 2,n=32,33,18,22,23	-0.5 (6.21)	0.1 (9.47)	1.9 (5.11)	-1.1 (6.56)	1.2 (8.41)
MCHC,Week 4,n=31,31,19,20,25	1.6 (7.36)	2.3 (11.94)	2.6 (9.46)	0.1 (5.17)	2.4 (9.32)
MCHC,Week 8,n=28,24,18,20,20	6.1 (8.97)	6.7 (10.98)	6.4 (9.09)	0.6 (9.53)	6.7 (8.19)
MCHC,Week 12,n=25,23,18,20,20	6.5 (9.77)	6.7 (9.03)	5.9 (14.20)	1.3 (9.55)	4.9 (7.81)
MCHC,Week 16,n=22,21,17,17,17	8.3 (9.80)	8.9 (12.41)	10.2 (8.50)	0.9 (11.52)	4.5 (9.62)
MCHC,Week 20,n=19,18,14,16,14	7.7 (8.43)	10.8 (9.53)	9.0 (8.60)	3.4 (10.38)	4.6 (12.48)
MCHC,Week 24,n=16,16,13,15,14	4.7 (7.50)	14.6 (11.04)	4.9 (9.97)	3.0 (7.46)	4.9 (11.49)
MCHC,Week 28,n=13,14,10,12,11	4.5 (7.78)	9.2 (11.52)	8.9 (11.41)	2.8 (13.57)	-0.4 (7.86)
MCHC,Week 32,n=13,11,8,10,11	6.9 (9.33)	8.4 (10.45)	8.8 (9.05)	6.7 (8.88)	1.4 (8.58)
MCHC,Week 36,n=10,10,8,10,10	6.9 (5.11)	6.7 (9.72)	13.5 (8.07)	7.9 (11.44)	4.2 (5.90)
MCHC,Week 40,n=10,9,7,8,9	11.5 (9.89)	11.3 (7.75)	14.4 (12.45)	5.1 (15.30)	13.9 (12.39)
MCHC,Week 44,n=8,8,4,5,8	12.5 (7.17)	9.9 (9.86)	13.5 (4.12)	5.2 (4.60)	12.1 (10.99)
MCHC,Week 48,n=6,7,2,6,4	13.3 (9.07)	11.9 (9.84)	10.5 (13.44)	3.8 (11.48)	9.3 (9.32)
MCHC,Week 52,n=6,4,3,4,3	16.5 (5.47)	18.8 (5.68)	24.0 (3.46)	11.3 (5.06)	5.0 (9.85)
Hemoglobin,Week 2,n=38,39,24,24,25	1.2 (6.50)	2.5 (6.85)	1.3 (8.72)	-2.4 (7.08)	-0.9 (5.44)
Hemoglobin,Week 4,n=36,37,24,22,27	3.0 (6.37)	2.8 (8.17)	2.5 (6.55)	-1.0 (8.45)	-2.1 (6.86)
Hemoglobin,Week 8,n=34,29,23,22,21	5.9 (9.57)	4.7 (9.59)	3.1 (7.00)	-1.4 (10.54)	-2.8 (7.41)
Hemoglobin,Week 12,n=31,28,23,22,22	5.8 (7.85)	8.4 (10.62)	4.7 (6.24)	-3.2 (11.11)	-1.4 (7.10)
Hemoglobin,Week 16,n=27,26,21,19,19	2.6 (6.00)	5.8 (8.87)	4.2 (7.03)	-3.8 (10.55)	-1.7 (7.47)
Hemoglobin,Week 20,n=25,23,18,18,16	2.0 (7.89)	7.4 (9.69)	3.3 (5.58)	-4.6 (11.32)	-0.6 (6.22)
Hemoglobin,Week 24,n=22,21,16,16,16	2.2 (8.67)	7.0 (9.99)	5.4 (6.38)	-3.1 (12.05)	-0.9 (6.43)
Hemoglobin,Week 28,n=18,18,12,14,13	0.3 (9.68)	5.8 (11.83)	2.8 (6.92)	-4.4 (11.45)	-1.5 (8.88)
Hemoglobin,Week 32,n=19,15,10,12,13	0.9 (9.04)	5.1 (10.88)	2.0 (9.42)	-3.0 (10.05)	0.8 (9.64)
Hemoglobin,Week 36,n=15,12,10,12,12	4.4 (7.97)	4.8 (11.91)	4.0 (7.26)	-2.6 (10.93)	1.3 (9.68)
Hemoglobin,Week 40,n=14,11,8,10,10	1.3 (8.03)	3.8 (12.40)	6.3 (5.47)	-3.4 (11.24)	-0.4 (7.86)
Hemoglobin,Week 44,n=11,10,6,8,9	0.0 (8.00)	6.7 (14.60)	2.3 (7.84)	-0.3 (11.70)	2.8 (12.85)
Hemoglobin,Week 48,n=9,8,4,8,5	2.4 (7.57)	4.8 (12.62)	2.8 (12.69)	-4.6 (14.66)	7.6 (15.57)
Hemoglobin,Week 52,n=8,5,5,5,4	2.9 (5.33)	8.6 (12.84)	10.4 (13.28)	4.4 (6.47)	2.8 (13.57)

27. Secondary Outcome

Title	Part A: Change From Baseline in Hematology Parameter-Hematocrit
Description	Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2,n=38,39,24,24,25	0.0040 (0.01988)	0.0060 (0.02186)	0.0008 (0.02909)	-0.0063 (0.02491)	-0.0030 (0.01813)
Week 4,n=36,37,24,22,27	0.0059 (0.01903)	0.0048 (0.02635)	0.0040 (0.01531)	-0.0035 (0.02676)	-0.0087 (0.02004)
Week 8,n=34,29,23,22,21	0.0101 (0.02601)	0.0054 (0.03213)	0.0019 (0.02110)	-0.0054 (0.03286)	-0.0159 (0.01918)
Week 12,n=31,28,23,22,22	0.0087 (0.02386)	0.0148 (0.03272)	0.0059 (0.01970)	-0.0118 (0.03281)	-0.0095 (0.02108)
Week 16,n=27,26,21,19,19	-0.0037 (0.02187)	0.0049 (0.02833)	0.0008 (0.01961)	-0.0135 (0.02976)	-0.0095 (0.02347)
Week 20,n=25,23,18,18,16	-0.0063 (0.02436)	0.0066 (0.03019)	-0.0015 (0.01398)	-0.0184 (0.02972)	-0.0062 (0.02076)
Week 24,n=22,21,16,16,16	-0.0017 (0.02882)	0.0010 (0.02839)	0.0089 (0.01973)	-0.0133 (0.03478)	-0.0077 (0.01599)
Week 28,n=18,18,12,14,13	-0.0089 (0.02917)	0.0039 (0.03455)	-0.0046 (0.01858)	-0.0186 (0.02814)	-0.0035 (0.02785)
Week 32,n=19,15,10,12,13	-0.0076 (0.02782)	0.0027 (0.02994)	-0.0060 (0.03161)	-0.0176 (0.02473)	0.0025 (0.02741)
Week 36,n=15,12,10,12,12	0.0012 (0.02603)	0.0036 (0.03232)	-0.0054 (0.01811)	-0.0198 (0.02570)	0.0018 (0.03090)
Week 40,n=14,11,8,10,10	-0.0115 (0.03075)	-0.0052 (0.03398)	-0.0009 (0.01086)	-0.0193 (0.02157)	-0.0160 (0.02099)
Week 44,n=11,10,6,7,9	-0.0185 (0.03039)	0.0054 (0.03463)	-0.0097 (0.02548)	-0.0126 (0.03225)	-0.0037 (0.03048)
Week 48,n=9,8,4,8,5	-0.0136 (0.02709)	-0.0025 (0.03217)	-0.0053 (0.04366)	-0.0216 (0.03428)	0.0144 (0.04123)
Week 52,n=8,5,5,5,4	-0.0135 (0.02112)	0.0016 (0.04082)	0.0058 (0.04370)	-0.0006 (0.01558)	0.0025 (0.03288)

28. Secondary Outcome

Title	Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Description	Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2,n=38,39,24,24,25	0.5 (1.35)	0.5 (1.64)	0.5 (1.38)	0.6 (1.38)	0.4 (1.44)
Week 4,n=36,37,24,22,27	0.9 (1.95)	1.1 (2.15)	1.0 (1.69)	0.6 (1.68)	0.6 (2.28)
Week 8,n=34,29,23,22,21	1.2 (2.54)	1.8 (3.27)	1.9 (2.72)	1.7 (2.34)	-0.2 (2.91)
Week 12,n=31,28,23,22,22	0.8 (3.41)	2.0 (4.29)	2.6 (3.14)	0.9 (3.16)	0.3 (4.07)
Week 16,n=27,26,21,19,19	1.0 (4.14)	2.2 (4.36)	3.1 (3.37)	0.4 (4.03)	-0.3 (4.98)
Week 20,n=25,23,18,18,16	1.2 (4.42)	1.8 (4.35)	2.1 (3.12)	-0.5 (4.72)	0.1 (3.54)
Week 24,n=22,21,16,16,16	1.1 (4.20)	1.1 (3.91)	2.6 (3.36)	-1.0 (4.44)	-1.6 (4.84)
Week 28,n=18,18,12,14,13	0.6 (4.02)	1.4 (4.19)	2.0 (2.26)	-0.4 (4.43)	-0.5 (3.95)
Week 32,n=19,15,10,12,13	0.9 (4.42)	2.0 (4.44)	1.3 (3.13)	0.3 (4.89)	-0.5 (3.64)
Week 36,n=15,12,10,12,12	1.8 (3.49)	1.6 (4.76)	0.9 (2.47)	-0.5 (4.93)	-0.2 (2.55)
Week 40,n=14,11,8,10,10	0.6 (3.73)	1.8 (5.25)	2.0 (2.83)	0.4 (4.95)	-2.1 (3.00)
Week 44,n=11,10,6,8,9	-0.5 (3.50)	2.5 (5.08)	1.7 (3.50)	-0.7 (6.87)	-0.7 (2.83)
Week 48,n=9,8,4,8,5	-0.4 (3.50)	3.3 (4.95)	2.3 (4.50)	-1.1 (6.92)	2.0 (2.12)
Week 52,n=8,5,5,5,4	-0.6 (3.02)	3.2 (5.12)	1.4 (4.16)	3.2 (5.72)	1.0 (2.58)

29. Secondary Outcome

Title	Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2,n=38,39,24,24,25	0.13 (0.571)	0.29 (0.730)	0.42 (0.512)	0.12 (0.494)	0.22 (0.678)
Week 4,n=36,37,24,22,27	0.53 (0.786)	0.58 (0.877)	0.55 (0.672)	0.25 (0.458)	0.36 (0.892)
Week 8,n=34,29,23,22,21	0.96 (1.041)	1.20 (1.056)	1.16 (1.178)	0.60 (0.751)	0.49 (1.022)
Week 12,n=31,28,23,22,22	0.94 (1.341)	1.43 (1.372)	1.38 (1.630)	0.44 (1.110)	0.47 (1.480)
Week 16,n=27,26,21,19,19	1.16 (1.345)	1.59 (1.617)	1.83 (1.424)	0.24 (1.508)	0.22 (1.927)
Week 20,n=25,23,18,18,16	1.24 (1.529)	1.69 (1.605)	1.48 (1.256)	0.14 (1.666)	0.39 (1.696)
Week 24,n=22,21,16,16,16	0.97 (1.491)	1.80 (1.663)	1.34 (1.230)	-0.04 (1.727)	-0.08 (2.041)
Week 28,n=18,18,12,14,13	0.91 (1.659)	1.48 (1.618)	1.47 (1.409)	0.21 (2.000)	-0.20 (1.493)
Week 32,n=19,15,10,12,13	1.01 (1.498)	1.57 (1.694)	1.27 (1.111)	0.68 (2.103)	-0.14 (1.413)
Week 36,n=15,12,10,12,12	1.42 (0.944)	1.29 (1.905)	1.39 (1.005)	0.68 (2.327)	0.15 (0.971)
Week 40,n=14,11,8,10,10	1.30 (0.818)	1.75 (1.914)	1.91 (1.373)	0.71 (2.617)	0.44 (1.492)
Week 44,n=11,10,6,8,9	1.16 (0.727)	1.83 (2.214)	1.63 (1.178)	0.30 (2.460)	0.77 (1.261)
Week 48,n=9,8,4,8,5	1.36 (0.633)	2.25 (2.194)	1.73 (1.389)	0.14 (2.934)	1.32 (1.119)
Week 52,n=8,5,5,5,4	1.44 (0.950)	2.70 (1.744)	2.24 (1.484)	1.84 (1.889)	0.80 (1.068)

30. Secondary Outcome

Title	Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Description	Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Week 2,n=38,39,24,24,25	0.01 (0.232)	0.02 (0.265)	-0.01 (0.303)	-0.10 (0.254)	-0.07 (0.221)
Week 4,n=36,37,24,22,27	0.01 (0.208)	-0.01 (0.311)	-0.01 (0.202)	-0.09 (0.268)	-0.14 (0.248)
Week 8,n=34,29,23,22,21	0.04 (0.249)	-0.04 (0.406)	-0.08 (0.300)	-0.16 (0.372)	-0.17 (0.219)
Week 12,n=31,28,23,22,22	0.03 (0.255)	0.05 (0.417)	-0.07 (0.265)	-0.20 (0.379)	-0.11 (0.237)
Week 16,n=27,26,21,19,19	-0.09 (0.238)	-0.07 (0.312)	-0.14 (0.282)	-0.19 (0.399)	-0.11 (0.303)
Week 20,n=25,23,18,18,16	-0.13 (0.263)	-0.03 (0.305)	-0.12 (0.183)	-0.20 (0.461)	-0.08 (0.286)
Week 24,n=22,21,16,16,16	-0.09 (0.270)	-0.06 (0.282)	-0.04 (0.234)	-0.11 (0.464)	-0.01 (0.289)
Week 28,n=18,18,12,14,13	-0.14 (0.295)	-0.04 (0.327)	-0.16 (0.231)	-0.18 (0.377)	-0.02 (0.387)
Week 32,n=19,15,10,12,13	-0.13 (0.292)	-0.09 (0.259)	-0.13 (0.330)	-0.22 (0.321)	0.04 (0.362)
Week 36,n=15,12,10,12,12	-0.08 (0.262)	-0.04 (0.378)	-0.10 (0.183)	-0.21 (0.358)	0.03 (0.391)
Week 40,n=14,11,8,10,10	-0.16 (0.234)	-0.16 (0.380)	-0.09 (0.189)	-0.22 (0.301)	-0.10 (0.330)
Week 44,n=11,10,6,7,9	-0.18 (0.286)	-0.10 (0.333)	-0.17 (0.320)	-0.10 (0.216)	-0.03 (0.367)
Week 48,n=9,8,4,8,5	-0.14 (0.240)	-0.23 (0.266)	-0.18 (0.457)	-0.20 (0.251)	0.04 (0.434)
Week 52,n=8,5,5,5,4	-0.16 (0.283)	-0.18 (0.370)	-0.02 (0.531)	-0.18 (0.192)	-0.05 (0.332)

31. Secondary Outcome

Title	Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Description	Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea . Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
calcium,Week 2,n=38,39,26,24,26	0.002 (0.1056)	0.006 (0.0853)	-0.008 (0.0817)	0.008 (0.1050)	0.013 (0.0812)
calcium,Week 4,n=37,38,25,23,27	0.009 (0.0974)	0.008 (0.0968)	0.013 (0.0649)	-0.016 (0.0922)	-0.001 (0.0899)
calcium,Week 8,n=34,31,24,22,23	0.032 (0.1114)	0.049 (0.0879)	0.005 (0.0764)	0.020 (0.0918)	0.013 (0.0615)
calcium,Week 12,n=32,28,24,22,21	0.019 (0.1200)	0.072 (0.0789)	-0.001 (0.0750)	0.011 (0.0913)	0.016 (0.0851)
calcium,Week 16,n=28,26,22,19,18	0.009 (0.0974)	0.050 (0.0808)	0.018 (0.0954)	-0.008 (0.0707)	0.044 (0.0768)
calcium,Week 20,n=25,23,19,18,16	0.018 (0.1080)	0.070 (0.0987)	0.032 (0.0933)	0.000 (0.0884)	0.012 (0.0932)
calcium,Week 24,n=22,21,16,17,16	0.008 (0.1029)	0.064 (0.0927)	0.032 (0.1077)	-0.002 (0.0748)	0.009 (0.0702)
calcium,Week 28,n=19,18,12,13,14	0.006 (0.1102)	0.066 (0.1106)	0.054 (0.1232)	0.018 (0.0838)	0.076 (0.1108)
calcium,Week 32,n=19,15,10,12,13	0.029 (0.1119)	0.044 (0.0923)	0.059 (0.0737)	-0.008 (0.0978)	0.075 (0.1271)
calcium,Week 36,n=15,12,10,12,13	0.016 (0.0789)	0.055 (0.0773)	0.075 (0.0738)	-0.038 (0.1025)	0.053 (0.0957)
calcium,Week 40,n=15,11,9,10,10	0.077 (0.1012)	0.016 (0.0662)	0.008 (0.0930)	-0.042 (0.0561)	0.037 (0.0589)
calcium,Week 44,n=11,11,6,8,9	0.042 (0.1480)	0.025 (0.0908)	-0.002 (0.0475)	-0.035 (0.1638)	0.054 (0.1146)
calcium,Week 48,n=9,8,5,8,5	-0.007 (0.1126)	0.028 (0.0956)	-0.018 (0.0769)	-0.035 (0.0769)	0.142 (0.0782)
calcium,Week 52,n=9,5,5,5,4	0.013 (0.0907)	0.076 (0.1108)	0.026 (0.0747)	-0.056 (0.1161)	0.083 (0.0624)
Carbon Dioxide,Week 2,n=38,39,26,24,26	0.7 (2.42)	0.6 (2.55)	0.5 (2.53)	-0.3 (2.31)	0.7 (2.24)
Carbon Dioxide,Week 4,n=37,38,25,23,27	0.1 (2.03)	0.2 (2.68)	0.4 (2.69)	0.2 (1.75)	0.1 (2.83)
Carbon Dioxide,Week 8,n=34,31,24,22,23	0.1 (3.39)	0.3 (2.89)	0.0 (2.69)	0.0 (2.01)	1.1 (2.24)
Carbon Dioxide,Week 12,n=32,28,24,22,21	0.1 (2.66)	0.6 (2.53)	-0.4 (2.28)	0.0 (1.94)	1.2 (1.73)
Carbon Dioxide,Week 16,n=28,26,22,19,18	0.1 (2.97)	0.5 (2.47)	0.8 (2.94)	-0.1 (1.88)	0.5 (2.55)
Carbon Dioxide,Week 20,n=25,23,19,18,16	0.1 (2.98)	-0.1 (3.17)	-0.1 (2.70)	-0.3 (2.83)	0.5 (2.68)
Carbon Dioxide,Week 24,n=22,21,16,17,16	0.4 (3.10)	0.4 (3.11)	-0.8 (2.65)	0.5 (2.29)	-0.2 (2.61)
Carbon Dioxide,Week 28,n=19,18,12,13,14	-1.6 (2.83)	0.4 (3.63)	-1.0 (2.04)	-0.4 (2.36)	0.4 (3.08)
Carbon Dioxide,Week 32,n=19,15,10,12,13	-1.0 (3.65)	0.8 (2.08)	-1.4 (2.17)	-0.6 (2.43)	0.2 (2.24)
Carbon Dioxide,Week 36,n=15,12,10,12,13	-1.1 (2.28)	0.3 (3.72)	-0.9 (1.97)	-0.3 (3.63)	1.0 (2.16)
Carbon Dioxide,Week 40,n=15,11,6,10,10	-1.5 (3.16)	0.9 (3.75)	-1.7 (2.35)	-0.8 (2.70)	0.4 (1.43)
Carbon Dioxide,Week 44,n=11,11,6,8,9	-1.7 (2.72)	1.6 (3.50)	0.0 (3.03)	-1.6 (1.60)	-0.1 (2.47)
Carbon Dioxide,Week 48,n=9,8,5,8,5	-2.6 (2.70)	0.5 (3.59)	-1.0 (2.65)	0.0 (1.77)	-0.2 (2.17)
Carbon Dioxide,Week 52,n=9,5,5,5,4	-1.1 (1.76)	1.2 (2.68)	-1.2 (1.48)	-0.4 (1.34)	1.8 (2.87)
Chloride,Week 2,n=38,39,26,24,26	1.1 (2.36)	0.6 (1.79)	0.7 (1.76)	1.0 (2.16)	0.8 (2.77)
Chloride,Week 4,n=37,38,25,23,27	1.8 (2.34)	1.6 (2.10)	1.4 (1.87)	0.7 (2.14)	1.4 (2.79)
Chloride,Week 8,n=34,31,24,22,23	2.5 (2.12)	2.4 (2.06)	2.0 (2.65)	1.0 (2.18)	2.1 (3.24)
Chloride,Week 12,n=32,28,24,22,21	2.9 (2.54)	1.8 (3.03)	2.4 (2.30)	0.6 (2.06)	2.0 (2.36)
Chloride,Week 16,n=28,26,22,19,18	3.0 (2.27)	2.3 (2.54)	2.2 (2.46)	1.1 (2.04)	2.4 (3.40)
Chloride,Week 20,n=25,23,19,18,16	3.3 (2.88)	2.0 (2.11)	2.1 (2.49)	1.3 (2.22)	2.5 (3.12)
Chloride,Week 24,n=22,21,16,17,16	3.4 (3.42)	2.7 (2.51)	1.6 (3.16)	1.0 (2.12)	2.3 (3.55)
Chloride,Week 28,n=19,18,12,13,14	3.9 (3.13)	2.8 (2.80)	2.8 (2.49)	0.2 (3.49)	2.9 (3.63)
Chloride,Week 32,n=19,15,10,12,13	3.4 (2.73)	1.9 (2.59)	2.0 (2.26)	-0.1 (4.17)	3.4 (3.43)
Chloride,Week 36,n=15,12,10,12,13	3.8 (1.74)	2.4 (2.78)	1.9 (2.47)	1.1 (1.88)	2.8 (3.37)
Chloride,Week 40,n=15,11,9,10,10	3.3 (2.49)	3.6 (1.12)	1.4 (1.94)	1.9 (1.45)	3.9 (3.03)
Chloride,Week 44,n=11,11,6,8,9	3.8 (2.23)	3.4 (1.91)	0.2 (2.14)	1.1 (2.03)	2.2 (4.52)
Chloride,Week 48,n=9,8,5,8,5	4.6 (1.88)	2.1 (2.23)	2.0 (1.58)	1.8 (1.58)	2.8 (3.11)
Chloride,Week 52,n=9,5,5,5,4	4.8 (1.09)	2.2 (1.64)	0.2 (3.83)	3.6 (1.95)	3.8 (4.11)
Glucose,Week 2,n=38,39,26,24,26	-0.03 (2.568)	-0.46 (1.671)	0.01 (1.237)	0.29 (1.358)	-0.44 (3.578)
Glucose,Week 4,n=37,38,25,23,27	-0.10 (2.676)	-0.35 (1.929)	0.38 (1.601)	0.31 (1.466)	-0.03 (4.387)
Glucose,Week 8,n=34,31,24,22,23	-0.29 (2.507)	-0.58 (2.606)	-0.12 (1.265)	0.10 (1.579)	-1.15 (5.685)
Glucose,Week 12,n=32,28,24,22,21	-0.64 (2.219)	-0.63 (2.134)	-0.33 (1.163)	-0.25 (1.164)	-1.76 (5.919)
Glucose,Week 16,n=28,26,22,19,18	-0.71 (2.485)	0.33 (1.941)	-0.29 (1.113)	-0.12 (1.414)	-1.15 (6.411)
Glucose,Week 20,n=25,23,19,18,16	-0.66 (2.701)	-0.46 (1.550)	0.46 (1.714)	-0.33 (1.435)	-1.96 (7.018)
Glucose,Week 24,n=22,21,16,17,16	-0.72 (2.701)	-0.44 (1.632)	-0.23 (1.217)	-0.38 (1.290)	-2.08 (6.953)
Glucose,Week 28,n=19,18,12,13,14	-0.91 (2.990)	-0.32 (1.510)	0.58 (1.627)	-0.25 (1.278)	-2.05 (7.699)
Glucose,Week 32,n=19,15,10,12,13	-0.74 (3.492)	-0.48 (1.533)	0.72 (1.795)	-0.05 (1.363)	-3.12 (7.818)
Glucose,Week 36,n=15,12,10,12,13	-1.14 (3.268)	-0.35 (1.861)	0.05 (1.019)	-0.50 (1.261)	-2.98 (7.786)
Glucose,Week 40,n=15,11,9,10,10	-0.99 (3.465)	-0.33 (2.376)	0.22 (1.203)	-0.22 (1.192)	-0.94 (3.589)
Glucose,Week 44,n=11,11,6,8,9	-1.39 (3.789)	-0.05 (1.954)	-0.27 (0.940)	0.30 (0.739)	-0.23 (2.001)
Glucose,Week 48,n=9,8,5,8,5	-1.39 (4.249)	-0.93 (2.077)	-0.62 (1.441)	-0.88 (1.369)	-0.36 (2.196)
Glucose,Week 52,n=9,5,5,5,4	-1.51 (4.466)	-0.94 (2.707)	-0.26 (1.316)	-0.72 (1.308)	0.45 (2.353)
Phosphate,Week 2,n=38,39,26,24,26	0.056 (0.2249)	-0.004 (0.1930)	0.017 (0.1886)	-0.025 (0.1622)	0.005 (0.1601)
Phosphate,Week 4,n=37,38,25,23,27	0.071 (0.1944)	-0.011 (0.2501)	0.093 (0.1848)	0.006 (0.1883)	0.008 (0.2087)
Phosphate,Week 8,n=34,31,24,22,23	0.088 (0.1786)	0.091 (0.2098)	0.112 (0.1588)	0.045 (0.1971)	0.055 (0.1746)
Phosphate,Week 12,n=32,28,24,22,21	0.122 (0.2404)	0.154 (0.2377)	0.190 (0.1725)	0.067 (0.1873)	0.079 (0.1946)
Phosphate,Week 16,n=28,26,22,19,18	0.113 (0.1976)	0.139 (0.2315)	0.146 (0.1612)	0.025 (0.1589)	0.039 (0.2238)
Phosphate,Week 20,n=25,23,19,18,16	0.070 (0.1860)	0.160 (0.2436)	0.141 (0.2257)	0.043 (0.1854)	0.060 (0.2183)
Phosphate,Week 24,n=22,21,16,17,16	0.132 (0.2066)	0.163 (0.2383)	0.181 (0.1778)	0.055 (0.1728)	0.101 (0.1811)
Phosphate,Week 28,n=19,18,12,13,14	0.156 (0.1873)	0.090 (0.2543)	0.191 (0.1980)	0.073 (0.2017)	0.190 (0.3143)
Phosphate,Week 32,n=19,15,10,12,13	0.164 (0.1166)	0.101 (0.2160)	0.214 (0.2086)	0.048 (0.1677)	0.155 (0.2713)
Phosphate,Week 36,n=15,12,10,12,13	0.111 (0.1786)	0.068 (0.2204)	0.304 (0.2112)	0.098 (0.1939)	0.151 (0.2114)
Phosphate,Week 40,n=15,11,6,10,10	0.221 (0.1902)	-0.007 (0.2007)	0.104 (0.1948)	0.073 (0.1849)	0.206 (0.2151)
Phosphate,Week 44,n=11,11,6,8,9	0.142 (0.2117)	0.025 (0.1874)	0.090 (0.2131)	-0.065 (0.2267)	0.218 (0.2184)
Phosphate,Week 48,n=9,8,5,8,5	0.029 (0.2136)	-0.054 (0.2203)	0.028 (0.2611)	-0.015 (0.1561)	0.132 (0.1972)
Phosphate,Week 52,n=9,5,5,5,4	0.049 (0.2235)	-0.036 (0.2779)	0.208 (0.1583)	0.036 (0.0865)	0.115 (0.1434)
Potassium,Week 2,n=38,39,26,24,26	0.03 (0.372)	-0.03 (0.437)	-0.02 (0.401)	0.18 (0.336)	0.08 (0.375)
Potassium,Week 4,n=37,38,25,23,27	-0.13 (0.319)	-0.04 (0.412)	-0.10 (0.453)	0.06 (0.329)	-0.03 (0.343)
Potassium,Week 8,n=34,31,24,22,23	0.01 (0.364)	0.05 (0.437)	-0.11 (0.422)	0.10 (0.333)	0.06 (0.399)
Potassium,Week 12,n=32,28,24,22,21	-0.12 (0.333)	0.15 (0.810)	-0.10 (0.346)	0.06 (0.336)	0.04 (0.446)
Potassium,Week 16,n=28,26,22,19,18	0.01 (0.376)	0.03 (0.439)	-0.02 (0.358)	0.15 (0.345)	0.15 (0.279)
Potassium,Week 20,n=25,23,19,18,16	0.04 (0.394)	0.07 (0.556)	0.02 (0.417)	0.10 (0.287)	0.16 (0.390)
Potassium,Week 24,n=22,21,16,17,16	0.05 (0.447)	-0.01 (0.403)	-0.13 (0.368)	0.15 (0.371)	0.16 (0.411)
Potassium,Week 28,n=19,18,12,13,14	0.12 (0.288)	0.07 (0.470)	0.17 (0.414)	0.08 (0.297)	0.23 (0.418)
Potassium,Week 32,n=19,15,10,12,13	0.16 (0.437)	0.01 (0.448)	0.17 (0.333)	0.19 (0.365)	0.25 (0.443)
Potassium,Week 36,n=15,12,10,12,13	0.16 (0.429)	-0.07 (0.475)	0.18 (0.408)	0.18 (0.341)	0.21 (0.403)
Potassium,Week 40,n=15,11,9,10,10	0.24 (0.534)	-0.03 (0.476)	0.01 (0.276)	0.03 (0.450)	0.28 (0.355)
Potassium,Week 44,n=11,11,6,8,9	0.16 (0.287)	-0.13 (0.478)	-0.13 (0.288)	0.15 (0.385)	0.16 (0.488)
Potassium,Week 48,n=9,8,5,8,5	0.21 (0.352)	0.06 (0.644)	-0.04 (0.182)	0.16 (0.283)	0.52 (0.432)
Potassium,Week 52,n=9,5,5,5,4	0.22 (0.186)	-0.16 (0.434)	-0.10 (0.418)	0.06 (0.445)	0.20 (0.365)
Sodium,Week 2,n=38,39,26,24,26	0.3 (2.11)	0.0 (2.33)	-0.8 (2.37)	-0.2 (1.52)	0.9 (2.92)
Sodium,Week 4,n=37,38,25,23,27	0.7 (2.15)	0.4 (2.11)	0.2 (2.29)	0.0 (1.43)	0.6 (2.65)
Sodium,Week 8,n=34,31,24,22,23	1.1 (2.10)	0.9 (3.12)	0.1 (2.32)	0.5 (1.50)	1.7 (2.91)
Sodium,Week 12,n=32,28,24,22,21	1.8 (2.46)	0.5 (3.90)	0.6 (1.76)	0.5 (1.79)	2.1 (2.37)
Sodium,Week 16,n=28,26,22,19,18	1.0 (2.28)	0.6 (3.09)	-0.2 (2.25)	-0.3 (1.37)	2.3 (3.59)
Sodium,Week 20,n=25,23,19,18,16	1.0 (2.23)	0.6 (2.79)	-0.3 (2.60)	-0.6 (0.92)	2.3 (3.52)
Sodium,Week 24,n=22,21,16,17,16	0.9 (2.31)	1.0 (1.83)	-0.4 (2.00)	0.4 (1.50)	1.9 (2.96)
Sodium,Week 28,n=19,18,12,13,14	0.9 (2.27)	1.2 (2.75)	0.5 (1.93)	-0.8 (3.22)	2.4 (3.54)
Sodium,Week 32,n=19,15,10,12,13	0.7 (2.31)	-0.3 (2.63)	-0.2 (2.04)	-0.8 (3.16)	3.2 (4.13)
Sodium,Week 36,n=15,12,10,12,13	0.5 (1.96)	0.6 (2.43)	-0.4 (2.07)	-0.2 (1.85)	2.8 (3.60)
Sodium,Week 40,n=15,11,9,10,10	0.1 (2.17)	1.2 (2.23)	-1.2 (2.49)	0.5 (1.58)	2.9 (3.07)
Sodium,Week 44,n=11,11,6,8,9	0.5 (1.97)	0.4 (2.58)	-2.0 (2.53)	-0.8 (1.28)	1.8 (3.77)
Sodium,Week 48,n=9,8,5,8,5	-0.3 (1.87)	0.8 (2.76)	-0.6 (2.07)	0.3 (1.91)	1.6 (2.70)
Sodium,Week 52,n=9,5,5,5,4	0.7 (1.66)	0.4 (2.51)	-0.8 (3.11)	1.6 (1.14)	3.5 (3.32)
Urea,Week 2,n=38,39,26,24,26	0.05 (1.210)	-0.16 (1.776)	0.28 (1.439)	-0.31 (1.458)	-0.32 (1.240)
Urea,Week 4,n=37,38,25,23,27	-0.09 (1.592)	-0.61 (1.514)	-0.06 (1.277)	-0.22 (1.022)	-0.27 (1.700)
Urea,Week 8,n=34,31,24,22,23	-0.36 (1.938)	-0.99 (1.826)	-0.40 (1.574)	-0.91 (0.970)	-0.34 (0.965)
Urea,Week 12,n=32,28,24,22,21	-0.65 (1.617)	-1.20 (1.778)	-0.62 (1.501)	-1.12 (1.457)	-0.35 (1.316)
Urea,Week 16,n=28,26,22,19,18	-0.56 (2.009)	-0.52 (1.612)	-0.72 (1.232)	-0.40 (1.580)	-0.07 (1.701)
Urea,Week 20,n=25,23,19,18,16	-0.30 (1.675)	-0.70 (1.379)	-0.70 (1.197)	-0.31 (1.470)	-0.77 (1.900)
Urea,Week 24,n=22,21,16,17,16	-0.48 (1.901)	-0.22 (2.044)	-0.80 (1.717)	-0.65 (1.457)	-0.64 (2.019)
Urea,Week 28,n=19,18,12,13,14	-0.45 (1.745)	-0.42 (1.510)	-0.73 (1.317)	0.23 (1.111)	-0.31 (1.495)
Urea,Week 32,n=19,15,10,12,13	-0.16 (2.086)	-0.64 (1.479)	-0.83 (1.382)	-0.76 (1.071)	0.17 (2.609)
Urea,Week 36,n=15,12,10,12,13	0.06 (1.967)	-1.43 (1.828)	-0.93 (1.113)	-0.01 (0.973)	-0.22 (2.297)
Urea,Week 40,n=15,11,9,10,10	-0.17 (1.775)	-0.78 (0.603)	-0.98 (1.237)	-0.76 (1.552)	0.32 (1.886)
Urea,Week 44,n=11,11,6,8,9	-0.46 (3.119)	-1.05 (1.234)	-0.63 (1.359)	-0.76 (1.274)	-1.09 (1.727)
Urea,Week 48,n=9,8,5,8,5	-0.18 (3.535)	-1.58 (1.450)	-0.06 (1.311)	-0.51 (1.225)	0.44 (1.282)
Urea,Week 52,n=9,5,5,5,4	-0.26 (2.508)	-1.22 (1.671)	-0.76 (1.647)	-0.82 (0.782)	-0.45 (1.475)

32. Secondary Outcome

Title	Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Description	Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Albumin,Week 2,n=38,39,26,24,26	0.3 (2.29)	0.9 (1.79)	0.8 (1.88)	-0.9 (2.64)	-0.7 (2.24)
Albumin,Week 4,n=37,38,25,23,27	0.9 (2.41)	2.0 (2.84)	1.6 (1.50)	-1.4 (2.46)	-0.9 (2.46)
Albumin,Week 8,n=34,31,24,22,23	1.9 (2.76)	3.1 (2.35)	2.1 (1.85)	-1.1 (2.35)	-0.6 (1.80)
Albumin,Week 12,n=32,28,24,22,21	2.0 (2.26)	3.4 (2.50)	3.1 (1.54)	-0.5 (2.81)	0.2 (1.87)
Albumin,Week 16,n=28,26,22,19,18	1.7 (2.29)	2.8 (2.52)	2.8 (2.44)	-1.2 (2.41)	0.6 (2.48)
Albumin,Week 20,n=25,23,19,18,16	1.8 (2.46)	3.9 (2.68)	2.8 (2.15)	-0.9 (2.70)	0.3 (2.11)
Albumin,Week 24,n=22,21,16,17,16	1.6 (2.77)	3.8 (2.36)	3.7 (1.85)	0.0 (2.83)	0.3 (1.88)
Albumin,Week 28,n=19,18,12,13,14	1.5 (1.61)	3.5 (3.38)	2.4 (2.78)	-0.5 (2.82)	0.4 (2.98)
Albumin,Week 32,n=19,15,10,12,13	2.2 (2.03)	3.6 (3.68)	2.2 (2.66)	-0.7 (3.20)	1.1 (2.93)
Albumin,Week 36,n=15,12,10,12,13	3.1 (2.61)	4.3 (3.75)	2.9 (2.08)	-1.3 (3.25)	0.2 (3.02)
Albumin,Week 40,n=15,11,9,10,10	3.2 (1.97)	3.9 (3.78)	2.4 (2.07)	-1.1 (2.96)	-0.5 (2.27)
Albumin,Week 44,n=11,11,6,8,9	3.2 (2.36)	4.1 (3.36)	2.2 (2.23)	0.4 (3.07)	0.6 (2.19)
Albumin,Week 48,n=9,8,5,8,5	3.4 (2.13)	4.4 (3.20)	1.6 (2.70)	-0.8 (3.28)	2.0 (2.92)
Albumin,Week 52,n=9,5,5,5,4	3.7 (2.45)	5.2 (1.64)	4.0 (2.55)	-1.2 (0.84)	1.5 (4.12)
Protein,Week 2,n=38,39,26,24,26	-2.6 (3.68)	-2.4 (3.13)	-1.9 (2.73)	-1.7 (3.31)	-1.7 (3.16)
Protein,Week 4,n=37,38,25,23,27	-2.5 (3.49)	-2.4 (4.39)	-1.8 (2.81)	-2.0 (3.64)	-2.0 (4.05)
Protein,Week 8,n=34,31,24,22,23	-1.9 (3.53)	-1.6 (4.16)	-2.2 (3.67)	-0.7 (3.10)	-0.7 (3.30)
Protein,Week 12,n=32,28,24,22,21	-1.7 (3.19)	-1.3 (3.72)	-0.8 (3.06)	1.0 (3.68)	0.9 (3.67)
Protein,Week 16,n=28,26,22,19,18	-2.3 (3.43)	-2.0 (3.67)	-1.9 (3.70)	0.2 (3.20)	1.0 (3.68)
Protein,Week 20,n=25,23,19,18,16	-1.9 (3.44)	-0.4 (4.69)	-1.3 (2.84)	0.6 (3.45)	0.4 (2.63)
Protein,Week 24,n=22,21,16,17,16	-1.1 (3.64)	-0.9 (4.39)	0.0 (2.85)	1.5 (4.86)	0.8 (3.09)
Protein,Week 28,n=19,18,12,13,14	-2.4 (3.30)	-0.8 (5.27)	-2.7 (2.67)	-0.2 (4.39)	1.6 (4.20)
Protein,Week 32,n=19,15,10,12,13	-1.4 (3.52)	-1.5 (4.67)	-2.1 (4.07)	-0.3 (4.45)	2.6 (3.78)
Protein,Week 36,n=15,12,10,12,13	-0.3 (3.48)	-0.8 (4.69)	-0.5 (2.51)	-0.3 (4.11)	1.8 (3.51)
Protein,Week 40,n=15,11,9,10,10	-0.5 (3.38)	-1.5 (4.93)	-2.1 (1.76)	-0.4 (3.27)	1.4 (3.03)
Protein,Week 44,n=11,11,6,8,9	0.3 (2.65)	-0.4 (4.06)	-2.0 (3.52)	2.3 (5.50)	1.7 (2.60)
Protein,Week 48,n=9,8,5,8,5	0.3 (4.69)	-0.1 (3.76)	-1.8 (4.49)	1.4 (4.98)	3.2 (2.28)
Protein,Week 52,n=9,5,5,5,4	-0.4 (3.54)	1.0 (4.69)	0.6 (4.88)	-1.0 (3.54)	1.8 (4.43)

33. Secondary Outcome

Title	Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
Description	Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
ALT,Week 2,n=38,39,26,24,26	8.2 (17.71)	5.3 (14.63)	10.1 (23.12)	-0.6 (3.27)	1.8 (15.16)
ALT,Week 4,n=37,38,25,23,27	6.6 (11.17)	6.6 (16.09)	5.2 (6.10)	-1.2 (4.20)	-3.1 (9.80)
ALT,Week 8,n=34,31,24,22,23	6.0 (14.70)	9.5 (12.71)	4.7 (8.25)	-2.8 (4.19)	-6.8 (12.81)
ALT,Week 12,n=32,28,24,22,21	4.7 (6.91)	4.4 (10.82)	4.0 (6.85)	-3.3 (5.39)	-7.0 (11.88)
ALT,Week 16,n=28,26,22,19,18	4.1 (8.11)	2.2 (9.86)	5.2 (10.08)	-3.5 (5.23)	-6.6 (14.22)
ALT,Week 20,n=25,23,19,18,16	16.1 (51.67)	4.9 (15.83)	8.6 (11.73)	2.3 (22.33)	-8.1 (14.38)
ALT,Week 24,n=22,21,16,17,16	8.3 (13.62)	2.5 (14.71)	16.4 (33.68)	-2.8 (6.58)	-9.4 (13.61)
ALT,Week 28,n=19,18,12,13,14	6.7 (8.75)	2.9 (14.59)	12.1 (23.96)	-1.9 (3.95)	-8.9 (12.65)
ALT,Week 32,n=19,15,10,12,13	6.6 (11.06)	5.0 (14.05)	5.1 (9.45)	-2.0 (4.45)	-10.0 (12.40)
ALT,Week 36,n=15,12,10,12,13	8.7 (13.58)	6.0 (15.22)	4.5 (8.44)	-2.8 (2.77)	-10.0 (13.87)
ALT,Week 40,n=15,11,9,10,10	5.3 (8.85)	7.3 (19.52)	5.4 (5.61)	0.1 (11.82)	-2.1 (6.77)
ALT,Week 44,n=11,11,6,8,9	1.8 (5.51)	5.5 (15.53)	2.7 (7.09)	-0.4 (7.15)	-7.0 (4.42)
ALT,Week 48,n=9,8,5,8,5	2.3 (6.54)	4.5 (16.52)	3.6 (10.48)	-3.5 (3.12)	0.2 (11.50)
ALT,Week 52,n=9,5,5,5,4	1.3 (5.98)	1.6 (19.63)	8.8 (10.03)	-4.4 (1.52)	5.3 (20.81)
ALP,Week 2,n=38,39,26,24,26	-9.3 (15.76)	-11.4 (7.46)	-11.4 (8.50)	-3.0 (5.88)	-2.6 (5.81)
ALP,Week 4,n=37,38,25,23,27	-15.5 (13.96)	-13.4 (12.75)	-14.2 (10.17)	-2.2 (8.83)	5.3 (27.51)
ALP,Week 8,n=34,31,24,22,23	-16.8 (11.61)	-10.4 (13.73)	-15.3 (7.14)	2.9 (9.95)	1.6 (33.37)
ALP,Week 12,n=32,28,24,22,21	-19.2 (15.60)	-7.0 (10.15)	-15.0 (8.06)	6.6 (13.21)	-5.3 (16.83)
ALP,Week 16,n=28,26,22,19,18	-18.2 (15.36)	-8.0 (12.61)	-14.6 (8.56)	1.1 (12.90)	-0.3 (14.43)
ALP,Week 20,n=25,23,19,18,16	-14.4 (21.82)	-4.4 (12.89)	-13.3 (9.58)	5.9 (19.44)	-1.0 (12.41)
ALP,Week 24,n=22,21,16,17,16	-16.3 (20.32)	-6.2 (13.76)	-12.5 (9.08)	6.9 (16.34)	-1.8 (20.27)
ALP,Week 28,n=19,18,12,13,14	-17.6 (23.06)	-4.3 (14.99)	-17.5 (6.56)	1.6 (13.28)	2.9 (19.72)
ALP,Week 32,n=19,15,10,12,13	-15.9 (22.94)	-6.1 (11.89)	-12.6 (6.93)	-2.3 (17.00)	5.2 (18.44)
ALP,Week 36,n=15,12,10,12,13	-20.3 (24.22)	-7.3 (11.18)	-9.6 (12.51)	-1.8 (15.49)	7.3 (20.95)
ALP,Week 40,n=15,11,9,10,10	-14.5 (22.71)	-7.4 (10.16)	-9.9 (11.35)	-0.2 (15.17)	12.3 (24.69)
ALP,Week 44,n=11,11,6,8,9	-19.4 (24.30)	-6.2 (13.48)	-4.0 (10.86)	2.8 (19.93)	11.9 (24.93)
ALP,Week 48,n=9,8,5,8,5	-24.4 (28.77)	-6.5 (8.45)	-4.4 (12.82)	1.5 (18.31)	7.2 (17.06)
ALP,Week 52,n=9,5,5,5,4	-26.0 (29.20)	-8.0 (9.14)	-3.6 (7.60)	1.0 (19.34)	-1.5 (11.00)
AST,Week 2,n=38,39,26,24,26	6.1 (8.07)	3.7 (4.81)	4.5 (7.11)	-0.3 (2.66)	0.4 (6.18)
AST,Week 4,n=37,38,25,23,27	5.4 (8.43)	5.9 (6.74)	5.0 (3.96)	-1.0 (2.75)	-0.7 (7.10)
AST,Week 8,n=34,31,24,22,23	6.4 (6.43)	10.6 (8.90)	6.7 (7.90)	0.1 (2.74)	-1.6 (7.72)
AST,Week 12,n=32,28,24,22,21	7.6 (9.02)	9.0 (5.64)	6.5 (5.24)	0.5 (3.62)	0.1 (8.74)
AST,Week 16,n=28,26,22,19,18	8.5 (8.94)	7.0 (5.79)	8.0 (7.28)	0.2 (4.45)	1.0 (11.88)
AST,Week 20,n=25,23,19,18,16	14.6 (27.52)	7.7 (7.24)	9.0 (7.46)	4.3 (20.22)	1.4 (12.10)
AST,Week 24,n=22,21,16,17,16	9.8 (8.52)	7.6 (6.75)	10.5 (10.02)	0.6 (4.40)	-1.3 (8.29)
AST,Week 28,n=19,18,12,13,14	9.0 (7.23)	8.1 (7.30)	9.4 (10.61)	1.1 (3.88)	-0.1 (9.01)
AST,Week 32,n=19,15,10,12,13	8.8 (7.63)	9.2 (7.72)	8.0 (4.94)	0.6 (3.65)	1.2 (9.49)
AST,Week 36,n=15,12,10,12,13	10.6 (8.85)	10.8 (8.09)	7.6 (5.02)	1.3 (2.56)	0.2 (9.27)
AST,Week 40,n=15,11,9,10,10	8.9 (4.56)	8.7 (10.82)	9.1 (4.11)	4.7 (13.17)	6.7 (11.36)
AST,Week 44,n=11,11,6,8,9	8.1 (3.56)	9.2 (8.91)	8.3 (5.09)	3.5 (4.81)	2.3 (3.24)
AST,Week 48,n=9,8,5,8,5	8.1 (4.04)	11.8 (12.63)	9.8 (7.29)	1.3 (4.68)	6.4 (5.59)
AST,Week 52,n=9,5,5,5,4	7.1 (3.33)	9.2 (4.97)	11.6 (5.68)	-0.2 (3.63)	4.3 (6.85)

34. Secondary Outcome

Title	Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters including bilirubin, creatinine, direct bilirubin and indirect bilirubin. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	42	39	26	27	27
Bilirubin,Week 2,n=38,39,26,24,26	1.8 (2.73)	1.5 (3.12)	1.9 (3.73)	-1.1 (1.94)	-1.0 (3.45)
Bilirubin,Week 4,n=37,38,25,23,27	2.4 (5.05)	1.9 (3.10)	1.8 (2.76)	-1.8 (2.52)	-1.5 (5.22)
Bilirubin,Week 8,n=34,31,24,22,23	3.0 (3.58)	2.8 (4.81)	0.9 (2.95)	-2.3 (2.50)	-3.2 (5.31)
Bilirubin,Week 12,n=32,28,24,22,21	4.3 (8.49)	2.8 (3.58)	2.7 (3.44)	-1.0 (2.40)	-2.9 (4.52)
Bilirubin,Week 16,n=28,26,22,19,18	2.7 (4.68)	4.4 (4.53)	3.9 (3.50)	-0.9 (1.85)	-3.3 (4.25)
Bilirubin,Week 20,n=25,23,19,18,16	4.7 (9.09)	4.3 (4.36)	3.6 (3.58)	-1.4 (2.20)	-3.1 (4.67)
Bilirubin,Week 24,n=22,21,16,17,16	4.9 (6.29)	3.0 (4.41)	4.8 (3.60)	-1.1 (1.80)	-1.7 (3.34)
Bilirubin,Week 28,n=19,18,12,13,14	4.4 (5.86)	3.7 (3.77)	3.1 (3.18)	-0.8 (1.92)	-3.2 (3.72)
Bilirubin,Week 32,n=19,15,10,12,13	4.2 (4.95)	4.0 (4.54)	2.7 (2.91)	-0.8 (2.53)	-3.0 (3.74)
Bilirubin,Week 36,n=15,12,10,12,13	5.2 (4.66)	5.3 (5.42)	2.3 (2.91)	-0.9 (1.88)	-2.1 (4.91)
Bilirubin,Week 40,n=15,11,6,10,10	5.1 (4.18)	2.9 (4.13)	2.6 (2.07)	-1.1 (2.02)	-1.9 (4.18)
Bilirubin,Week 44,n=11,11,6,8,9	4.4 (6.14)	1.8 (3.52)	2.5 (2.17)	-0.1 (2.03)	-1.2 (3.23)
Bilirubin,Week 48,n=9,8,5,8,5	6.7 (6.22)	3.8 (3.62)	2.2 (1.79)	-1.1 (1.96)	-1.8 (2.49)
Bilirubin,Week 52,n=9,5,5,5,4	4.8 (5.09)	1.6 (3.58)	5.0 (4.36)	-1.0 (2.00)	1.8 (6.85)
Direct Bilirubin,Week 2,n=38,39,26,24,26	0.1 (1.03)	-0.1 (0.92)	0.1 (0.82)	0.0 (0.59)	-0.3 (0.75)
Direct Bilirubin,Week 4,n=37,38,25,23,27	0.3 (0.97)	0.1 (0.73)	0.1 (0.76)	-0.2 (0.83)	-0.6 (1.31)
Direct Bilirubin,Week 8,n=34,31,24,22,23	0.2 (1.01)	0.1 (0.72)	0.0 (0.29)	-0.1 (0.75)	-0.8 (1.31)
Direct Bilirubin,Week 12,n=32,28,24,22,21	0.3 (1.12)	0.1 (0.66)	0.2 (0.96)	-0.1 (0.75)	-0.6 (1.29)
Direct Bilirubin,Week 16,n=28,26,22,19,18	0.3 (1.19)	0.4 (0.98)	0.3 (0.63)	-0.1 (0.46)	-0.8 (1.40)
Direct Bilirubin,Week 20,n=25,23,19,18,16	1.4 (3.29)	0.1 (1.12)	0.4 (0.77)	-0.2 (0.65)	-0.9 (1.45)
Direct Bilirubin,Week 24,n=22,21,16,17,16	1.0 (1.59)	0.0 (0.89)	0.4 (0.81)	-0.4 (0.79)	-0.8 (1.24)
Direct Bilirubin,Week 28,n=19,18,12,13,14	0.7 (1.34)	-0.1 (1.08)	0.1 (0.90)	-0.5 (0.88)	-1.0 (1.52)
Direct Bilirubin,Week 32,n=19,15,10,12,13	0.5 (1.26)	0.3 (1.03)	0.1 (0.32)	-0.2 (0.58)	-1.2 (1.54)
Direct Bilirubin,Week 36,n=15,12,10,12,13	0.7 (1.22)	0.3 (1.44)	-0.1 (0.74)	-0.2 (0.58)	-1.2 (1.54)
Direct Bilirubin,Week 40,n=15,11,6,10,10	0.6 (1.18)	-0.4 (0.81)	-0.3 (0.71)	0.0 (0.00)	-1.4 (1.35)
Direct Bilirubin,Week 44,n=11,11,6,8,9	0.8 (0.98)	-0.4 (0.81)	0.2 (0.41)	0.0 (0.00)	-0.7 (1.00)
Direct Bilirubin,Week 48,n=9,8,5,8,5	1.2 (0.97)	-0.3 (0.71)	-0.6 (1.34)	0.0 (0.00)	-1.2 (1.10)
Direct Bilirubin,Week 52,n=9,5,5,5,4	1.0 (1.00)	-0.8 (1.10)	-0.2 (1.10)	-0.4 (0.89)	-0.5 (1.00)
Indirect Bilirubin,Week 2,n=38,39,26,24,26	1.7 (2.51)	1.6 (2.84)	1.8 (3.18)	-1.1 (1.75)	-0.7 (3.19)
Indirect Bilirubin,Week 4,n=37,38,25,23,27	2.1 (4.93)	1.9 (2.86)	1.8 (2.31)	-1.6 (2.19)	-0.9 (4.27)
Indirect Bilirubin,Week 8,n=34,31,24,22,23	2.8 (3.37)	2.7 (4.37)	0.9 (2.90)	-2.2 (2.47)	-2.4 (4.34)
Indirect Bilirubin,Week 12,n=32,28,24,22,21	4.0 (7.94)	2.7 (3.28)	2.5 (2.87)	-1.0 (2.63)	-2.3 (3.79)
Indirect Bilirubin,Week 16,n=28,26,22,19,18	2.4 (4.29)	4.0 (3.88)	3.6 (3.22)	-0.8 (1.84)	-2.5 (3.00)
Indirect Bilirubin,Week 20,n=25,23,19,18,16	3.3 (6.22)	4.2 (3.66)	3.2 (3.21)	-1.2 (2.23)	-2.2 (3.47)
Indirect Bilirubin,Week 24,n=22,21,16,17,16	4.0 (5.52)	3.0 (3.88)	4.4 (3.03)	-0.8 (1.64)	-0.9 (2.62)
Indirect Bilirubin,Week 28,n=19,18,12,13,14	3.7 (5.05)	3.8 (3.42)	3.0 (3.02)	-0.3 (1.80)	-2.2 (2.55)
Indirect Bilirubin,Week 32,n=19,15,10,12,13	3.7 (4.24)	3.7 (3.77)	2.6 (2.99)	-0.6 (2.35)	-1.8 (2.52)
Indirect Bilirubin,Week 36,n=15,12,10,12,13	4.5 (4.02)	5.0 (4.47)	2.4 (2.63)	-0.8 (1.66)	-0.8 (3.83)
Indirect Bilirubin,Week 40,n=15,11,6,10,10	4.5 (3.94)	3.3 (3.61)	2.9 (2.03)	-1.1 (2.02)	-0.5 (2.95)
Indirect Bilirubin,Week 44,n=11,11,6,8,9	3.5 (5.43)	2.2 (3.03)	2.3 (2.34)	-0.1 (2.03)	-0.6 (2.88)
Indirect Bilirubin,Week 48,n=9,8,5,8,5	5.4 (5.68)	4.0 (3.21)	2.8 (2.28)	-1.1 (1.96)	-0.6 (2.19)
Indirect Bilirubin,Week 52,n=9,5,5,5,4	3.8 (4.52)	2.4 (2.61)	5.2 (5.02)	-0.6 (1.95)	2.3 (6.13)
Creatinine,Week 2,n=38,39,26,24,26	4.96 (9.319)	4.10 (12.030)	0.71 (5.170)	-1.65 (6.165)	0.28 (7.485)
Creatinine,,Week 4,n=37,38,25,23,27	4.00 (11.061)	3.03 (12.685)	2.56 (6.760)	-0.64 (5.781)	0.48 (7.222)
Creatinine,Week 8,n=34,31,24,22,23	3.26 (10.522)	1.48 (14.285)	0.95 (6.027)	-2.93 (7.703)	2.43 (8.688)
Creatinine,,Week 12,n=32,28,24,22,21	2.88 (11.590)	-0.84 (16.780)	3.28 (6.334)	-3.09 (7.615)	1.46 (6.093)
Creatinine,,Week 16,n=28,26,22,19,18	3.87 (9.387)	1.16 (12.971)	1.27 (6.604)	-0.14 (9.654)	3.37 (15.068)
Creatinine,,Week 20,n=25,23,19,18,16	-0.87 (8.652)	0.33 (9.278)	-0.09 (5.721)	-0.18 (6.991)	4.73 (12.179)
Creatinine,Week 24,n=22,21,16,17,16	1.58 (9.671)	-0.45 (20.542)	1.86 (9.364)	-1.14 (8.093)	2.63 (7.834)
Creatinine,,Week 28,n=19,18,12,13,14	5.00 (12.803)	0.46 (17.574)	-1.33 (5.372)	-0.28 (4.970)	4.07 (7.431)
Creatinine, Week 32,n=19,15,10,12,13	3.88 (11.182)	-2.52 (20.459)	-1.33 (7.598)	0.59 (7.911)	4.10 (7.264)
Creatinine,,Week 36,n=15,12,10,12,13	1.09 (11.330)	-3.82 (22.270)	0.88 (7.151)	4.56 (9.011)	3.62 (11.433)
Creatinine,,Week 40,n=15,11,6,10,10	4.87 (11.617)	-1.45 (10.674)	-0.88 (9.831)	1.67 (9.527)	1.55 (10.630)
Creatinine, Week 44,n=11,11,6,8,9	0.03 (14.182)	-7.06 (19.793)	-2.38 (7.847)	0.23 (7.876)	3.96 (14.656)
Creatinine,,Week 48,n=9,8,5,8,5	7.21 (14.144)	-7.15 (26.680)	2.80 (8.917)	1.43 (5.646)	5.72 (18.804)
Creatinine,,Week 52,n=9,5,5,5,4	3.56 (6.903)	-5.10 (30.563)	4.20 (9.195)	1.78 (9.836)	12.23 (16.814)

35. Secondary Outcome

Title	Part A: Mean Serum Concentrations of Sirukumab
Description	Blood samples for Pharmacokinetic analysis of sirukumab serum concentrations were planned to be collected at specified time points.
Time Frame	Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52

Outcome Measure Data

Analysis Population Description

Safety Population. Data was not collected due to early termination of the study

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	0	0	0	0	0

36. Secondary Outcome

Title	Part A: Mean Serum Anti-sirukumab Antibodies
Description	Blood samples for Pharmacokinetic analysis of Serum anti-sirukumab antibodies were planned to be collected at specified time points.
Time Frame	Baseline (Week 0) and up to 52 weeks

Outcome Measure Data

Analysis Population Description

Safety Population. Data was not collected due to early termination of the study

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	0	0	0	0	0

37. Secondary Outcome

Title	Part A: Change From Baseline in Free and Total Interleukin-6 (IL-6) Over Time
Description	Blood samples for Pharmacodynamic analysis were planned but not collected due to early termination of study.
Time Frame	Baseline (Week 0) and up to 52 weeks

Outcome Measure Data

Analysis Population Description

Safety Population. Data was not collected due to early termination of the study

Arm/Group Title	PartA:SIR 100 mg SC q2w+6 Month Prednisone	PartA:SIR 100 mg SC q2w+3 Month Prednisone	PartA:SIR 50 mg SC q4w+6 Month Prednisone	PartA:Placebo SC q2w + 6 Month Prednisone	PartA:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
Measure Participants	0	0	0	0	0

38. Secondary Outcome

Title	Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.
Time Frame	Up to 120 weeks

Outcome Measure Data

Analysis Population Description

Safety-Part B Population included all randomized participants who received at least 1 dose of SC IP in Part A and entered Part B

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
All AEs	2 4.8%	1 2.6%	1 3.8%	2 7.4%	2 7.4%
All SAEs	0 0%	0 0%	0 0%	0 0%	0 0%
Corticosteroid related AEs	0 0%	0 0%	0 0%	1 3.7%	1 3.7%

39. Secondary Outcome

Title	Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.
Time Frame	Up to 120 weeks

Outcome Measure Data

Analysis Population Description

Safety-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
All AEs	4 9.5%	3 7.7%	2 7.7%	1 3.7%	0 0%
All SAEs	0 0%	0 0%	0 0%	0 0%	0 0%
Corticosteroid related AEs	0 0%	1 2.6%	0 0%	0 0%	1 3.7%

40. Secondary Outcome

Title	Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
SBP,Week 2,n=1,1,0,1,2	2.0 (NA)	15.0 (NA)	0.0 (NA)	6.5 (19.09)
SBP,Week 4,n=2,1,1,2,2	5.0 (21.21)	0.0 (NA)	6.0 (NA)	-1.5 (3.54)	1.5 (0.71)
SBP,Week 8,n=2,1,1,2,1	14.0 (8.49)	18.0 (NA)	-12.0 (NA)	-11.5 (10.61)	5.0 (NA)
SBP,Week 12,n=2,1,1,1,0	7.0 (1.41)	14.0 (NA)	8.0 (NA)	2.0 (NA)
SBP,Week 14,n=0,0,0,1,0	9.0 (NA)
SBP,Week 16,n=2,0,0,1,0	0.0 (0.00)	11.0 (NA)
SBP,Week 24,n=2,0,0,0,0	8.0 (0.00)
SBP,Week 36,n=2,0,0,0,0	11.0 (9.90)
SBP,Week 38,n=1,0,0,0,0	-6.0 (NA)
SBP,Week 40,n=1,0,0,0,0	-10.0 (NA)
SBP,Week follow up,n=2,1,0,1,1	3.0 (18.38)	-1.0 (NA)	22.0 (NA)	12.0 (NA)
DBP,Week 2,n=1,1,0,1,2	-10.0 (NA)	-8.0 (NA)	0.0 (NA)	7.0 (9.90)
DBP,Week 4,n=2,1,1,2,2	-3.0 (12.73)	-15.0 (NA)	6.0 (NA)	2.0 (5.66)	4.5 (3.54)
DBP,Week 8,n=2,1,1,2,1	3.0 (4.24)	-5.0 (NA)	-4.0 (NA)	4.0 (2.83)	-1.0 (NA)
DBP,Week 12,n=2,1,1,1,0	-5.0 (7.07)	-5.0 (NA)	1.0 (NA)	4.0 (NA)
DBP,Week 14,n=0,0,0,1,0	7.0 (NA)
DBP,Week 16,n=2,0,0,1,0	-5.0 (7.07)	15.0 (NA)
DBP,Week 24,n=2,0,0,0,0	1.0 (1.41)
DBP,Week 36,n=2,0,0,0,0	-2.0 (2.83)
DBP,Week 38,n=1,0,0,0,0	-8.0 (NA)
DBP,Week 40,n=1,0,0,0,0	-10.0 (NA)
DBP,Week follow up,n=2,1,0,1,1	-2.0 (5.66)	-7.0 (NA)	21.0 (NA)	3.0 (NA)

41. Secondary Outcome

Title	Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
SBP,Week 4,n=3,3,3,1,2	-23.7 (4.73)	-6.3 (5.51)	7.0 (25.36)	10.0 (NA)	-2.0 (8.49)
SBP,Week 8,n=2,1,2,0,2	-32.5 (14.85)	-6.0 (NA)	-7.5 (17.68)	-1.5 (0.71)
SBP,Week 12,n=1,1,1,1,1	-59.0 (NA)	-4.0 (NA)	15.0 (NA)	13.0 (NA)	-2.0 (NA)
SBP,Week 16,n=0,1,1,1,0	-8.0 (NA)	25.0 (NA)	-8.0 (NA)
SBP,Week 24,n=0,1,0,0,0	4.0 (NA)
SBP,Week 36,n=0,1,0,0,0	-26.0 (NA)
SBP,Week follow up,n=5,4,2,3,2	-7.4 (19.62)	-3.3 (8.54)	-17.5 (31.82)	10.7 (10.07)	5.0 (1.41)
DBP,Week 4,n=3,3,3,1,2	-8.3 (14.29)	0.3 (4.51)	7.7 (8.74)	-4.0 (NA)	-11.0 (11.31)
DBP,Week 8,n=2,1,2,0,2	-9.0 (2.83)	-10.0 (NA)	16.5 (2.12)	-6.0 (8.49)
DBP,Week 12,n=1,1,1,1,1	-22.0 (NA)	-6.0 (NA)	15.0 (NA)	8.0 (NA)	-9.0 (NA)
DBP,Week 16,n=0,1,1,1,0	0.0 (NA)	15.0 (NA)	-17.0 (NA)
DBP,Week 24,n=0,1,0,0,0	-10.0 (NA)
DBP,Week 36,n=0,1,0,0,0	-10.0 (NA)
DBP,Week follow up,n=5,4,2,3,2	3.4 (12.34)	-2.8 (4.57)	12.5 (10.61)	6.0 (4.36)	-2.0 (4.24)

42. Secondary Outcome

Title	Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Week 2,n=1,1,0,1,2	4.0 (NA)	7.0 (NA)	0.0 (NA)	4.0 (8.49)
Week 4,n=2,1,1,2,2	-2.0 (8.49)	6.0 (NA)	-10.0 (NA)	-17.0 (2.83)	-5.5 (9.19)
Week 8,n=2,1,1,2,1	0.0 (5.66)	3.0 (NA)	4.0 (NA)	-12.5 (9.19)	-4.0 (NA)
Week 12,n=2,1,1,1,0	-2.0 (2.83)	2.0 (NA)	4.0 (NA)	-12.0 (NA)
Week 14,n=0,0,0,1,0	-24.0 (NA)
Week 16,n=2,0,0,1,0	2.0 (2.83)	-14.0 (NA)
Week 24,n=2,0,0,0,0	5.0 (1.41)
Week 36,n=2,0,0,0,0	-2.0 (8.49)
Week 38,n=1,0,0,0,0	0.0 (NA)
Week 40,n=1,0,0,0,0	0.0 (NA)
Week follow up,n=2,1,0,1,1	5.0 (12.73)	-3.0 (NA)	-22.0 (NA)	6.0 (NA)

43. Secondary Outcome

Title	Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
Week 4,n=3,3,3,1,2	3.7 (1.53)	0.3 (3.51)	-14.7 (2.31)	-29.0 (NA)	-1.5 (6.36)
Week 8,n=2,1,2,0,2	8.0 (4.24)	4.0 (NA)	-5.5 (2.12)	-0.5 (0.71)
Week 12,n=1,1,1,1,1	11.0 (NA)	-4.0 (NA)	4.0 (NA)	6.0 (NA)	6.0 (NA)
Week 16,n=0,1,1,1,0	-4.0	-4.0	6.0 (NA)
Week 24,n=0,1,0,0,0	0.0 (NA)
Week 36,n=0,1,0,0,0	0.0 (NA)
Week follow up,n=5,4,2,3,2	1.4 (10.11)	4.0 (6.53)	-1.5 (2.12)	-7.7 (17.62)	7.5 (4.95)

44. Secondary Outcome

Title	Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Week 2,n=1,1,0,1,2	0.20 (NA)	0.50 (NA)	-0.40 (NA)	-0.65 (0.071)
Week 4,n=2,1,1,2,2	0.15 (0.071)	-0.50 (NA)	-0.30 (NA)	-0.10 (0.141)	0.30 (1.414)
Week 8,n=2,1,1,2,1	-0.15 (0.212)	0.00 (NA)	0.10 (NA)	-0.20 (0.000)	-0.50 (NA)
Week 12,n=2,1,1,1,0	-0.25 (0.071)	0.90 (NA)	0.50 (NA)	0.00 (NA)
Week 14,n=0,0,0,1,0	-0.20 (NA)
Week 16,n=2,0,0,1,0	-0.05 (0.071)	-0.10 (NA)
Week 24,n=2,0,0,0,0	-0.42 (0.163)
Week 36,n=2,0,0,0,0	-0.25 (0.071)
Week 38,n=1,0,0,0,0	0.00 (NA)
Week 40,n=1,0,0,0,0	0.00 (NA)
Week follow up,n=2,1,0,1,1	0.15 (0.071)	0.00 (NA)	0.50 (NA)	-0.60 (NA)

45. Secondary Outcome

Title	Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
Week 4,n=3,3,3,1,2	0.10 (0.458)	0.07 (0.115)	0.00 (0.300)	-0.20 (NA)	0.10 (0.283)
Week 8,n=2,1,2,0,2	-0.10 (0.566)	0.00 (NA)	-0.10 (0.283)	0.05 (0.354)
Week 12,n=1,1,1,1,1	-0.30 (NA)	0.40 (NA)	0.00 (NA)	0.00 (NA)	-0.50 (NA)
Week 16,n=0,1,1,1,0	0.20 (NA)	0.00 (NA)	-0.10 (NA)
Week 24,n=0,1,0,0,0	0.00 (NA)
Week 36,n=0,1,0,0,0	0.00 (NA)
Week follow up,n=5,4,2,3,2	0.06 (0.305)	0.15 (0.265)	0.00 (0.283)	-0.13 (0.252)	0.20 (0.283)

46. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Eosinophils,Week 2,n=1,1,0,1,2	-0.010 (NA)	-0.110 (NA)	0.000 (NA)	-0.010 (0.0141)
Eosinophils,Week 4,n=2,1,1,2,2	-0.015 (0.0212)	-0.210 (NA)	-0.010 (NA)	-0.030 (0.0283)	0.035 (0.0495)
Eosinophils,Week 8,n=2,1,1,2,1	-0.010 (0.0424)	-0.180 (NA)	0.040 (NA)	-0.120 (0.1838)	0.045 (0.0636)
Eosinophils,Week 12,n=2,0,1,1,0	-0.030 (0.0000)	0.030 (NA)	-0.160 (NA)
Eosinophils,Week 14,n=0,0,0,1,0	-0.290 (NA)
Eosinophils,Week 16,n=2,0,0,1,0	0.030 (0.0141)	-0.270 (NA)
Eosinophils,Week 24,n=2,0,0,0,0	-0.015 (0.0212)
Eosinophils,Week 36,n=2,0,0,0,0	-0.010 (0.0566)
Eosinophils,Week 38,n=1,0,0,0,0	0.020 (NA)
Eosinophils,Week 40,n=1,0,0,0,0	-0.030 (NA)
Leukocytes,Week 2,n=1,1,0,1,2	-0.20 (NA)	0.30 (NA)	2.60 (NA)	-2.30 (0.424)
Leukocytes,Week 4,n=2,1,1,2,2	0.25 (0.778)	-0.30 (NA)	0.20 (NA)	0.60 (1.697)	-1.45 (0.071)
Leukocytes,Week 8,n=2,1,1,2,1	-0.25 (1.061)	0.00 (NA)	0.60 (NA)	0.10 (0.000)	-0.95 (2.333)
Leukocytes,Week 12,n=2,0,1,1,0	-0.10 (0.990)	0.90 (NA)	-0.60 (NA)
Leukocytes,Week 14,n=0,0,0,1,0	0.40 (NA)
Leukocytes,Week 16,n=2,0,0,1,0	-0.45 (0.778)	-0.30 (NA)
Leukocytes,Week 24,n=2,0,0,0,0	-0.20 (0.424)
Leukocytes,Week 36,n=2,0,0,0,0	0.65 (0.354)
Leukocytes,Week 38,n=1,0,0,0,0	-0.50 (NA)
Leukocytes,Week 40,n=1,0,0,0,0	-1.30 (NA)
Lymphocytes,Week 2,n=1,1,0,1,2	-0.170 (NA)	0.000 (NA)	-0.400 (NA)	-0.160 (0.0990)
Lymphocytes,Week 4,n=2,1,1,2,2	0.110 (0.0566)	-0.340 (NA)	-0.010 (NA)	-0.035 (0.2051)	-0.115 (0.5162)
Lymphocytes,Week 8,n=2,1,1,2,1	-0.120 (0.0283)	0.160 (NA)	0.050 (NA)	-0.185 (0.3323)	-0.275 (0.4172)
Lymphocytes,Week 12,n=2,0,1,1,0	-0.030 (0.0283)	0.300 (NA)	-0.190 (NA)
Lymphocytes,Week 14,n=0,0,0,1,0	0.490 (NA)
Lymphocytes,Week 16,n=2,0,0,1,0	-0.230 (0.2828)	0.540 (NA)
Lymphocytes,Week 24,n=2,0,0,0,0	-0.320 (0.1697)
Lymphocytes,Week 36,n=2,0,0,0,0	0.195 (0.1768)
LymphocytesWeek 38,n=1,0,0,0,0	0.010 (NA)
Lymphocytes,Week 40,n=1,0,0,0,0	-0.160 (NA)
Neutrophils ,Week 2,n=1,1,0,1,2	-0.040 (NA)	0.510 (NA)	3.010 (NA)	-2.210 (0.5233)
Neutrophils ,Week 4,n=2,1,1,2,2	0.205 (0.5728)	0.400 (NA)	0.230 (NA)	0.740 (1.8950)	-1.420 (0.4950)
Neutrophils ,Week 8,n=2,1,1,2,2	-0.265 (0.6435)	0.060 (NA)	0.620 (NA)	0.485 (0.1909)	-0.790 (1.8385)
Neutrophils ,Week 12,n=2,0,1,1,0	0.020 (0.8061)	0.630 (NA)	-0.320 (NA)
Neutrophils ,Week 14,n=0,0,0,1,0	0.590 (NA)
Neutrophils ,Week 16,n=2,0,0,1,0	-0.235 (0.4879)	-0.050 (NA)
Neutrophils ,Week 24,n=2,0,0,0,0	0.085 (0.6859)
Neutrophils ,Week 36,n=2,0,0,0,0	0.540 (0.6788)
Neutrophils ,Week 38,n=1,0,0,0,0	-0.460 (NA)
Neutrophils,Week 40,n=1,0,0,0,0	-0.770 (NA)
Platelets ,Week 2,n=1,1,0,1,2	5.0 (NA)	4.0 (NA)	-27.0 (NA)	-20.5 (57.28)
Platelets,Week 4,n=2,1,1,2,2	-1.0 (4.24)	6.0 (NA)	-1.0 (NA)	-33.5 (30.41)	-42.0 (11.31)
Platelets,Week 8,n=2,1,1,2,1	7.0 (11.31)	-6.0 (NA)	2.0 (NA)	-20.5 (28.99)	-40.0 (0.00)
Platelets,Week 12,n=2,0,1,1,0	7.0 (7.07)	52.0 (NA)	12.0 (NA)
Platelets,Week 14,n=0,0,0,1,0	-31.0 (NA)
Platelets,Week 16,n=2,0,0,1,0	2.0 (1.41)	-97.0 (NA)
Platelets,Week 24,n=2,0,0,0,0	-18.5 (9.19)
Platelets,Week 36,n=2,0,0,0,0	10.0 (21.21)
Platelets,Week 38,n=1,0,0,0,0	-15.0 (NA)
Platelets,Week 40,n=1,0,0,0,0	-6.0 (NA)

47. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
Eosinophils,Week 4,n=3,3,2,1,2	-0.110 (0.1735)	-0.013 (0.0551)	-0.050 (0.0849)	-0.030 (NA)	0.415 (0.5869)
Eosinophils,Week 8,n=2,1,2,0,2	-0.070 (0.0707)	0.020 (NA)	0.020 (0.2546)	0.330 (0.4101)
Eosinophils,Week 12,n=1,1,1,1,1	-0.120 (NA)	-0.120 (NA)	-0.190 (NA)	0.070 (NA)	0.030 (NA)
Eosinophils,Week 16,n=0,1,1,1,0	-0.200 (NA)	-0.180 (NA)	-0.050 (NA)
Eosinophils,Week 24,n=0,1,0,0,0	-0.100 (NA)
Eosinophils,Week 36,n=0,1,0,0,0	-0.240 (NA)
Leukocytes,Week 4,n=3,3,2,1,2	0.40 (0.500)	0.30 (1.229)	0.50 (0.000)	-0.40 (NA)	1.30 (0.990)
Leukocytes,Week 8,n=2,1,2,0,2	0.25 (0.071)	0.10 (NA)	0.90 (0.424)	0.65 (0.071)
Leukocytes,Week 12,n=1,1,1,1,1	-1.30 (NA)	-1.60 (NA)	0.80 (NA)	-1.50 (NA)	-0.70 (NA)
Leukocytes,Week 16,n=0,1,1,1,0	-0.50 (NA)	0.30 (NA)	-1.30 (NA)
Leukocytes,Week 24,n=0,1,0,0,0	-0.60 (NA)
Leukocytes,Week 36,n=0,1,0,0,0	-1.10 (NA)
Lymphocytes,Week 4,n=3,3,2,1,2	0.293 (0.2136)	0.077 (0.2442)	0.370 (0.0990)	-0.960 (NA)	0.015 (0.2475)
Lymphocytes,Week 8,n=2,1,2,0,2	0.470 (0.0707)	0.090 (NA)	0.205 (0.0495)	-0.180 (0.4243)
Lymphocytes,Week 12,n=1,1,1,1,1	-0.210 (NA)	0.140 (NA)	0.190 (NA)	0.380 (NA)	-0.610 (NA)
Lymphocytes,Week 16,n=0,1,1,1,0	-0.040 (NA)	0.340 (NA)	-0.520 (NA)
Lymphocytes,Week 24,n=0,1,0,0,0	0.000 (NA)
Lymphocytes,Week 36,n=0,1,0,0,0	-0.240 (NA)
Neutrophils ,Week 4,n=3,3,2,1,2	0.183 (0.4196)	0.333 (1.0108)	0.180 (0.1414)	0.390 (NA)	0.815 (0.0212)
Neutrophils ,Week 8,n=2,1,2,0,2	-0.205 (0.1909)	0.010 (NA)	0.600 (0.0283)	0.500 (0.8627)
Neutrophils ,Week 12,n=1,1,1,1,1	-0.750 (NA)	-1.440 (NA)	0.820 (NA)	-1.770 (NA)	-0.140 (NA)
Neutrophils ,Week 16,n=0,1,1,1,0	-0.220 (NA)	0.230 (NA)	-0.210 (NA)
Neutrophils ,Week 24,n=0,1,0,0,0	-0.350 (NA)
Neutrophils ,Week 36,n=0,1,0,0,0	-0.420 (NA)
Platelets,Week 4,n=3,3,2,1,2	15.0 (31.43)	-6.0 (9.64)	10.5 (3.54)	26.0 (NA)	-14.0 (4.24)
Platelets,Week 8,n=2,1,2,0,2	17.5 (23.33)	-25.0 (NA)	10.0 (22.63)	31.5 (4.95)
Platelets,Week 12,n=1,1,1,1,1	27.0 (NA)	-20.0 (NA)	14.0 (NA)	-8.0 (NA)	14.0 (NA)
Platelets,Week 16,n=0,1,1,1,0	-4.0 (NA)	15.0 (NA)	-19.0 (NA)
Platelets,Week 24,n=0,1,0,0,0	-20.0 (NA)
Platelets,Week 36,n=0,1,0,0,0	-16.0 (NA)

48. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
MCHC,Week 2,n=1,1,0,1,1	-3.0 (NA)	-1.0 (NA)	-3.0 (NA)	20.0 (NA)
MCHC,Week 4,n=2,1,0,2,1	-1.5 (3.54)	1.0 (NA)	3.5 (2.12)	23.0 (NA)
MCHC,Week 8,n=2,1,0,2,1	0.0 (12.73)	16.0 (NA)	3.5 (14.85)	9.0 (NA)
MCHC,Week 12,n=2,0,0,1,0	-5.5 (0.71)	19.0 (NA)
MCHC,Week 14,n=0,0,0,1,0	5.0 (NA)
MCHC,Week 16,n=2,0,0,1,0	0.0 (1.41)	11.0 (NA)
MCHC,Week 24,n=2,0,0,0,0	-3.0 (2.83)
MCHC,Week 36,n=2,0,0,0,0	-4.0 (4.24)
MCHC,Week 38,n=1,0,0,0,0	-3.0 (NA)
MCHC,Week 40,n=1,0,0,0,0	4.0 (NA)
Hemoglobin,Week 2,n=1,1,0,1,2	-4.0 (NA)	-2.0 (NA)	7.0 (NA)	10.0 (4.24)
Hemoglobin,Week 4,n=2,1,1,2,2	0.5 (0.71)	-2.0 (NA)	-9.0 (NA)	-0.5 (10.61)	8.0 (8.49)
Hemoglobin,Week 8,n=2,1,1,2,1	4.0 (1.41)	3.0 (NA)	0.0 (NA)	-0.5 (10.61)	9.0 (4.24)
Hemoglobin,Week 12,n=2,0,1,1,0	1.5 (3.54)	0.0 (NA)	-6.0 (NA)
Hemoglobin,Week 14,n=0,0,0,1,0	0.0 (NA)
Hemoglobin,Week 16,n=2,0,0,1,0	0.0 (0.00)	8.0 (NA)
Hemoglobin,Week 24,n=2,0,0,0,0	-0.5 (7.78)
Hemoglobin,Week 36,n=2,0,0,0,0	-1.5 (3.54)
Hemoglobin,Week 38,n=1,0,0,0,0	-3.0 (NA)
Hemoglobin,Week 40,n=1,0,0,0,0	-3.0 (NA)

49. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimenin Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
MCHC,Week 4,n=3,3,2,1,2	-18.0 (NA)	-14.0 (4.24)	-3.0 (1.41)	0.0 (NA)	-7.0 (11.31)
MCHC,Week 8,n=0,1,2,0,2	-8.0 (NA)	-0.5 (16.26)	8.0 (19.80)
MCHC,Week 12,n=0,1,1,1,1	-10.0 (NA)	11.0 (NA)	21.0 (NA)	11.0 (NA)
MCHC,Week 16,n=0,1,1,1,0	-9.0 (NA)	-1.0 (NA)	8.0 (NA)
MCHC,Week 24,n=0,1,0,0,0	-17.0 (NA)
MCHC,Week 36,n=0,1,0,0,0	-15.0 (NA)
Hemoglobin,Week 4,n=3,3,2,1,2	-4.0 (5.29)	-6.3 (3.51)	2.0 (9.90)	-2.0 (NA)	-5.5 (3.54)
Hemoglobin,Week 8,n=2,1,2,0,2	-6.0 (14.14)	-4.0 (NA)	4.0 (12.73)	-1.5 (10.61)
Hemoglobin,Week 12,n=1,1,1,1,1	-5.0 (NA)	-1.0 (NA)	20.0 (NA)	8.0 (NA)	5.0 (NA)
Hemoglobin,Week 16,n=0,1,1,1,0	-2.0 (NA)	19.0 (NA)	2.0 (NA)
Hemoglobin,Week 24,n=0,1,0,0,0	-4.0 (NA)
Hemoglobin,Week 36,n=0,1,0,0,0	2.0 (NA)

50. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Hematocrit,Week 2,n=1,1,0,1,2	-0.0080 (NA)	-0.0060 (NA)	0.0250 (NA)	0.0235 (0.01202)
Hematocrit,Week 4,n=2,1,1,2,2	0.0030 (0.00141)	-0.0080 (NA)	-0.0250 (NA)	-0.0060 (0.03111)	0.0105 (0.00354)
Hematocrit,Week 8,n=2,1,1,2,2	0.0115 (0.01909)	-0.0110 (NA)	-0.0030 (NA)	-0.0040 (0.01414)	0.0260 (0.02546)
Hematocrit,Week 12,n=2,0,1,1,0	0.0125 (0.01202)	-0.0060 (NA)	-0.0420 (NA)
Hematocrit,Week 14,n=0,0,0,1,0	-0.0080 (NA)
Hematocrit,Week 16,n=2,0,0,1,0	0.0000 (0.00141)	0.0080 (NA)
Hematocrit,Week 24,n=2,0,0,0,0	0.0040 (0.02687)
Hematocrit,Week 36,n=2,0,0,0,0	0.0005 (0.01626)
Hematocrit,Week 38,n=1,0,0,0,0	-0.0050 (NA)
Hematocrit,Week 40,n=1,0,0,0,0	-0.0140 (NA)

51. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
Hematocrit,Week 4,n=3,3,2,1,2	-0.0047 (0.02570)	-0.0057 (0.01834)	0.0115 (0.02616)	-0.0040 (NA)	-0.0070 (0.00849)
Hematocrit,Week 8,n=2,1,2,0,2	-0.0185 (0.04879)	0.0000 (NA)	0.0135 (0.01768)	-0.0120 (0.00424)
Hematocrit,Week 12,n=1,1,1,1,1	-0.0120 (NA)	0.0080 (NA)	0.0470 (NA)	-0.0010 (NA)	0.0030 (NA)
Hematocrit,Week 16,n=0,1,1,1,0	0.0060 (NA)	0.0610 (NA)	-0.0030 (NA)
Hematocrit,Week 24,n=0,1,0,0,0	0.0100 (NA)
Hematocrit,Week 36,n=0,1,0,0,0	0.0280 (NA)

52. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Week 2,n=1,1,0,1,2	-2.0 (NA)	1.0 (NA)	0.0 (NA)	0.5 (3.54)
Week 4,n=2,1,1,2,2	1.5 (0.71)	1.0 (NA)	1.0 (NA)	-1.5 (0.71)	0.5 (2.12)
Week 8,n=2,1,1,2,1	1.5 (2.12)	-1.0 (NA)	0.0 (NA)	-2.5 (0.71)	2.0 (2.83)
Week 12,n=2,0,1,1,0	2.5 (0.71)	0.0 (NA)	-6.0 (NA)
Week 14,n=0,0,0,1,0	-5.0 (NA)
Week 16,n=2,0,0,1,0	0.5 (0.71)	-4.0 (NA)
Week 24,n=2,0,0,0,0	1.5 (0.71)
Week 36,n=2,0,0,0,0	2.5 (2.12)
Week 38,n=1,0,0,0,0	0.0 (NA)
Week 40,n=1,0,0,0,0	-2.0 (NA)

53. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
Week 4,n=3,3,2,1,2	0.7 (1.15)	1.3 (1.53)	0.0 (0.00)	-3.0 (NA)	2.0 (1.41)
Week 8,n=2,1,2,0,2	-0.5 (0.71)	1.0 (NA)	0.0 (1.41)	1.5 (0.71)
Week 12,n=1,1,1,1,1	0.0 (NA)	2.0 (NA)	-1.0 (NA)	1.0 (NA)	2.0 (NA)
Week 16,n=0,1,1,1,0	1.0 (NA)	0.0 (NA)	2.0 (NA)
Week 24,n=0,1,0,0,0	3.0 (NA)
Week 36,n=0,1,0,0,0	4.0 (NA)

54. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Week 2,n=1,1,0,1,2	-1.10 (NA)	0.20 (NA)	-0.20 (NA)	0.60 (0.990)
Week 4,n=2,1,1,2,2	0.30 (0.000)	0.60 (NA)	0.20 (NA)	-0.05 (0.354)	1.00 (1.273)
Week 8,n=2,1,1,2,2	0.30 (0.424)	1.30 (NA)	0.30 (NA)	-0.45 (0.919)	0.70 (0.141)
Week 12,n=2,1,1,1,0	0.25 (0.212)	NA (NA)	0.30 (NA)	0.00 (NA)
Week 14,n=0,0,0,1,0	-0.90 (NA)
Week 16,n=2,0,0,1,0	0.00 (0.00)	-0.10 (NA)
Week 24,n=2,0,0,0,0	0.10 (0.141)
Week 36,n=2,0,0,0,0	0.25 (0.354)
Week 38,n=1,0,0,0,0	-0.40 (NA)
Week 40,n=1,0,0,0,0	0.40 (NA)

55. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
Week 4,n=3,3,2,1,2	-0.33 (0.757)	-0.47 (0.451)	-0.25 (0.354)	-1.00 (NA)	0.00 (0.849)
Week 8,n=2,1,2,0,2	-0.15 (0.354)	-0.60 (NA)	0.00 (1.273)	1.10 (2.121)
Week 12,n=1,1,1,1,1	-0.10 (NA)	-0.50 (NA)	0.70 (NA)	2.20 (NA)	1.80 (NA)
Week 16,n=0,1,1,1,0	-0.80 (NA)	-0.20 (NA)	1.30 (NA)
Week 24,n=0,1,0,0,0	-0.80 (NA)
Week 36,n=0,1,0,0,0	-0.20 (NA)

56. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Week 2,n=1,1,0,1,2	0.00 (NA)	-0.10 (NA)	0.30 (NA)	0.25 (0.071)
Week 4,n=2,1,1,2,2	0.00 (0.000)	-0.10 (NA)	-0.30 (NA)	0.00 (0.283)	0.10 (0.141)
Week 8,n=2,1,1,2,2	0.10 (0.141)	0.00 (NA)	0.00 (NA)	0.05 (0.212)	0.15 (0.071)
Week 12,n=2,1,1,1,0	0.10 (0.141)	NA (NA)	0.00 (NA)	-0.20 (NA)
Week 14,n=0,0,0,1,0	0.10 (NA)
Week 16,n=2,0,0,1,0	0.00 (0.00)	-0.20 (NA)
Week 24,n=2,0,0,0,0	0.00 (0.283)
Week 36,n=2,0,0,0,0	-0.05 (0.071)
Week 38,n=1,0,0,0,0	0.00 (NA)
Week 40,n=1,0,0,0,0	0.00 (NA)

57. Secondary Outcome

Title	Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
Week 4,n=3,3,2,1,2	-0.03 (0.252)	-0.10 (0.173)	0.10 (0.283)	0.10 (NA)	-0.20 (0.000)
Week 8,n=2,1,2,0,2	-0.15 (0.495)	0.00 (NA)	0.10 (0.283)	-0.20 (0.000)
Week 12,n=1,1,1,1,1	-0.10 (NA)	0.10 (NA)	0.60 (NA)	0.00 (NA)	-0.10 (NA)
Week 16,n=0,1,1,1,0	0.10 (NA)	0.70 (NA)	-0.10 (NA)
Week 24,n=0,1,0,0,0	0.00 (NA)
Week 36,n=0,1,0,0,0	0.10 (NA)

58. Secondary Outcome

Title	Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Calcium,Week 2,n=1,1,0,1,2	0.060 (NA)	0.000 (NA)	0.100 (NA)	0.040 (0.0000)
Calcium,Week 4,n=2,1,1,2,2	0.070 (0.0707)	-0.100 (NA)	-0.080 (NA)	0.050 (0.1273)	0.000 (0.0566)
Calcium,Week 8,n=2,1,1,2,1	0.120 (0.0283)	-0.140 (NA)	0.000 (NA)	-0.020 (0.0849)	0.020 (NA)
Calcium,Week 12,n=2,1,1,1,0	0.110 (0.0990)	NA (NA)	0.000 (NA)	-0.040 (NA)
Calcium,Week 14,n=0,0,0,1,0	0.000 (NA)
Calcium,Week 16,n=2,0,0,1,0	0.000 (0.1131)	0.140 (NA)
Calcium,Week 24,n=2,0,0,0,0	0.040 (0.0566)
Calcium,Week 36,n=2,0,0,0,0	-0.050 (0.0707)
Calcium,Week 38,n=1,0,0,0,0	-0.020 (NA)
Calcium,Week 40,n=1,0,0,0,0	-0.020 (NA)
Carbon Dioxide,Week 2,n=1,1,0,1,2	3.0 (NA)	-5.0 (NA)	-2.0 (NA)	-1.0 (0.00)
Carbon Dioxide,Week 4,n=2,1,1,2,2	3.5 (3.54)	-3.0 (NA)	2.0 (NA)	-1.5 (2.12)	-3.5 (2.12)
Carbon Dioxide,Week 8,n=2,1,1,2,1	2.5 (2.12)	-4.0 (NA)	1.0 (NA)	-1.0 (0.00)	-1.0 (NA)
Carbon Dioxide,Week 12,n=2,1,1,1,0	3.5 (2.12)	NA (NA)	2.0 (NA)	-3.0 (NA)
Carbon Dioxide,Week 14,n=0,0,0,1,0	1.0 (NA)
Carbon Dioxide,Week 16,n=2,0,0,1,0	0.5 (0.71)	-1.0 (NA)
Carbon Dioxide,Week 24,n=2,0,0,0,0	3.0 (0.00)
Carbon Dioxide,Week 36,n=2,0,0,0,0	1.5 (4.95)
Carbon Dioxide,Week 38,n=1,0,0,0,0	1.0 (NA)
Carbon Dioxide,Week 40,n=1,0,0,0,0	-2.0 (NA)
Chloride,Week 2,n=1,1,0,1,2	-1.0 (NA)	2.0 (NA)	0.0 (NA)	1.0 (1.41)
Chloride,Week 4,n=2,1,1,2,2	-2.5 (0.71)	1.0 (NA)	6.0 (NA)	0.5 (2.12)	1.5 (0.71)
Chloride,Week 8,n=2,1,1,2,1	-3.0 (1.41)	0.0 (NA)	2.0 (NA)	1.0 (1.41)	3.0 (NA)
Chloride,Week 12,n=2,1,1,1,0	-2.5 (0.71)	NA (NA)	-1.0 (NA)	1.0 (NA)
Chloride,Week 14,n=0,0,0,1,0	1.0 (NA)
Chloride,Week 16,n=2,0,0,1,0	-1.0 (0.00)	0.0 (NA)
Chloride,Week 24,n=2,0,0,0,0	-2.0 (1.41)
Chloride,Week 36,n=2,0,0,0,0	0.5 (0.71)
Chloride,Week 38,n=1,0,0,0,0	-1.0 (NA)
Chloride,Week 40,n=1,0,0,0,0	0.0 (NA)
Glucose,Week 2,n=1,1,0,1,2	0.80 (NA)	0.20 (NA)	1.30 (NA)	1.25 (1.202)
Glucose,Week 4,n=2,1,1,2,2	0.95 (1.202)	0.40 (NA)	-0.70 (NA)	-0.05 (2.192)	-0.05 (0.212)
Glucose,Week 8,n=2,1,1,2,1	0.70 (0.424)	0.00 (NA)	0.10 (NA)	0.30 (1.414)	0.20 (NA)
Glucose,Week 12,n=2,1,1,1,0	0.60 (0.566)	0.00 (NA)	0.00 (NA)	-0.10 (NA)
Glucose,Week 14,n=0,0,0,1,0	-0.10 (NA)
Glucose,Week 16,n=2,0,0,1,0	0.55 (0.071)	-0.20 (NA)
Glucose,Week 24,n=2,0,0,0,0	0.65 (0.354)
Glucose,Week 36,n=2,0,0,0,0	0.35 (0.071)
Glucose,Week 38,n=1,0,0,0,0	0.50 (NA)
Glucose,Week 40,n=1,0,0,0,0	3.60 (NA)
Phosphate,Week 2,n=1,1,0,1,2	0.050 (NA)	-0.100 (NA)	-0.300 (NA)	0.000 (0.0707)
Phosphate,Week 4,n=2,1,1,2,2	-0.125 (0.1768)	-0.250 (NA)	0.000 (NA)	0.050 (0.2828)	-0.050 (0.1414)
Phosphate,Week 8,n=2,1,1,2,1	0.025 (0.1061)	-0.200 (NA)	0.150 (NA)	-0.075 (0.3182)	-0.050 (NA)
Phosphate,Week 12,n=2,1,1,1,0	-0.025 (0.1768)	NA (NA)	0.050 (NA)	0.200 (NA)
Phosphate,Week 14,n=0,0,0,1,0	0.250 (NA)
Phosphate,Week 16,n=2,0,0,1,0	-0.050 (0.0707)	0.300
Phosphate,Week 24,n=2,0,0,0,0	0.050 (0.0000)
Phosphate,Week 36,n=2,0,0,0,0	-0.025 (0.0354)
Phosphate,Week 38,n=1,0,0,0,0	0.000 (NA)
Phosphate,Week 40,n=1,0,0,0,0	0.000 (NA)
Potassium,Week 2,n=1,1,0,1,2	0.10 (NA)	-0.20	0.00 (NA)	0.10 (0.283)
Potassium,Week 4,n=2,1,1,2,2	0.20 (0.283)	-0.20 (NA)	0.20 (NA)	-0.30 (0.141)	0.00 (0.141)
Potassium,Week 8,n=2,1,1,2,1	0.10 (0.424)	0.00 (NA)	0.50 (NA)	-0.30 (0.424)	0.10 (NA)
Potassium,Week 12,n=2,1,1,1,0	0.25 (0.636)	NA (NA)	0.30 (NA)	0.10 (NA)
Potassium,Week 14,n=0,0,0,1,0	0.00 (NA)
Potassium,Week 16,n=2,0,0,1,0	0.00 (0.141)	-0.10 (NA)
Potassium,Week 24,n=2,0,0,0,0	0.40 (0.283)
Potassium,Week 36,n=2,0,0,0,0	0.20 (0.424)
Potassium,Week 38,n=1,0,0,0,0	0.00 (NA)
Potassium,Week 40,n=1,0,0,0,0	-0.30 (NA)
Sodium,Week 2,n=1,1,0,1,2	0.0 (NA)	-2.0 (NA)	-2.0 (NA)	1.0 (0.00)
Sodium,Week 4,n=2,1,1,2,2	-0.5 (0.71)	-1.0 (NA)	3.0 (NA)	0.5 (4.95)	0.5 (0.71)
Sodium,Week 8,n=2,1,1,2,1	-2.0 (1.41)	-1.0 (NA)	0.0 (NA)	-0.5 (3.54)	2.0 (NA)
Sodium,Week 12,n=2,1,1,1,0	-1.0 (1.41)	NA (NA)	-2.0 (NA)	2.0 (NA)
Sodium,Week 14,n=0,0,0,1,0	2.0 (NA)
Sodium,Week 16,n=2,0,0,1,0	-1.5 (0.71)	0.0 (NA)
Sodium,Week 24,n=2,0,0,0,0	-0.5 (0.71)
Sodium,Week 36,n=2,0,0,0,0	2.0 (0.00)
Sodium,Week 38,n=1,0,0,0,0	-1.0 (NA)
Sodium,Week 40,n=1,0,0,0,0	2.0 (NA)
Urea,Week 2,n=1,1,0,1,2	-1.00 (NA)	-2.50 (NA)	0.50 (NA)	0.75 (0.354)
Urea,Week 4,n=2,1,1,2,2	1.25 (0.354)	-1.00 (NA)	1.50 (NA)	1.50 (0.707)	0.25 (0.354)
Urea,Week 8,n=2,1,1,2,1	2.00 (2.121)	-2.00 (NA)	3.00 (NA)	-0.25 (0.354)	0.50 (NA)
Urea,Week 12,n=2,1,1,1,0	-0.50 (2.121)	NA (NA)	1.50 (NA)	0.00 (NA)
Urea,Week 14,n=0,0,0,1,0	1.00 (NA)
Urea,Week 16,n=2,0,0,1,0	1.25 (1.768)	1.50 (NA)
Urea,Week 24,n=2,0,0,0,0	0.00 (0.000)
Urea,Week 36,n=2,0,0,0,0	0.00 (0.707)
Urea,Week 38,n=1,0,0,0,0	1.50 (NA)
Urea,Week 40,n=1,0,0,0,0	1.50 (NA)

59. Secondary Outcome

Title	Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
Calcium,Week 4,n=3,3,2,1,2	0.067 (0.0643)	-0.093 (0.0462)	0.060 (0.1414)	0.120 (NA)	-0.040 (0.0566)
Calcium,Week 8,n=2,1,2,0,2	0.010 (0.0707)	-0.060 (NA)	0.050 (0.0707)	0.020 (0.0000)
Calcium,Week 12,n=1,1,1,1,1	0.020 (NA)	0.040 (NA)	0.160 (NA)	0.000 (NA)	0.000 (NA)
Calcium,Week 16,n=0,1,1,1,0	0.040 (NA)	0.180 (NA)	0.060 (NA)
Calcium,Week 24,n=0,1,0,0,0	-0.040 (NA)
Calcium,Week 36,n=0,1,0,0,0	-0.020 (NA)
Carbon Dioxide,Week 4,n=3,3,2,1,2	0.0 (2.00)	-2.7 (1.15)	0.0 (2.83)	-1.0 (NA)	-3.0 (0.00)
Carbon Dioxide,Week 8,n=2,1,2,0,2	-0.5 (0.71)	-4.0 (NA)	0.5 (3.54)	-1.5 (0.71)
Carbon Dioxide,Week 12,n=1,1,1,1,1	1.0 (NA)	-2.0 (NA)	0.0 (NA)	0.0 (NA)	-3.0 (NA)
Carbon Dioxide,Week 16,n=0,1,1,1,0	0.0 (NA)	1.0 (NA)	0.0 (NA)
Carbon Dioxide,Week 24,n=0,1,0,0,0	1.0 (NA)
Carbon Dioxide,Week 36,n=0,1,0,0,0	-2.0 (NA)
Chloride,Week 4,n=3,3,2,1,2	0.7 (1.15)	0.3 (3.06)	-2.5 (4.95)	-4.0 (NA)	0.5 (0.71)
Chloride,Week 8,n=2,1,2,0,2	-2.0 (0.00)	-1.0 (NA)	-2.5 (2.12)	0.5 (2.12)
Chloride,Week 12,n=1,1,1,1,1	-2.0 (NA)	0.0 (NA)	-4.0 (NA)	-2.0 (NA)	-2.0 (NA)
Chloride,Week 16,n=0,1,1,1,0	1.0 (NA)	-5.0 (NA)	-1.0 (NA)
Chloride,Week 24,n=0,1,0,0,0	1.0 (NA)
Chloride,Week 36,n=0,1,0,0,0	0.0 (NA)
Glucose,Week 4,n=3,3,2,1,2	-0.10 (0.608)	0.33 (1.115)	-0.80 (0.849)	0.70 (NA)	-0.40 (0.707)
Glucose,Week 8,n=2,1,2,0,2	0.15 (1.061)	0.60 (NA)	-0.85 (0.071)	0.55 (0.354)
Glucose,Week 12,n=1,1,1,1,1	0.00 (NA)	2.80 (NA)	0.30 (NA)	-0.50 (NA)	0.20 (NA)
Glucose,Week 16,n=0,1,1,1,0	1.40 (NA)	0.30 (NA)	2.10 (NA)
Glucose,Week 24,n=0,1,0,0,0	1.10 (NA)
Glucose,Week 36,n=0,1,0,0,0	2.10 (NA)
Phosphate,Week 4,n=3,3,2,1,2	0.050 (0.2646)	-0.033 (0.1155)	-0.125 (0.1768)	0.050 (NA)	-0.025 (0.1061)
Phosphate,Week 8,n=2,1,2,0,2	0.150 (0.1414)	-0.100 (NA)	-0.250 (0.2121)	-0.075 (0.0354)
Phosphate,Week 12,n=1,1,1,1,1	0.050 (NA)	-0.250 (NA)	0.000 (NA)	0.250 (NA)	-0.100 (NA)
Phosphate,Week 16,n=0,1,1,1,0	0.100 (NA)	0.000 (NA)	0.000 (NA)
Phosphate,Week 24,n=0,1,0,0,0	0.050 (NA)
Phosphate,Week 36,n=0,1,0,0,0	-0.150 (NA)
Potassium,Week 4,n=3,3,2,1,2	-0.27 (0.289)	0.03 (0.321)	0.10 (0.141)	0.40 (NA)	-0.10 (0.141)
Potassium,Week 8,n=2,1,2,0,2	-0.25 (0.212)	-0.30 (NA)	0.00 (0.424)	-0.10 (0.283)
Potassium,Week 12,n=1,1,1,1,1	-0.20 (NA)	-0.20 (NA)	0.40 (NA)	0.00 (NA)	-0.40 (NA)
Potassium,Week 16,n=0,1,1,1,0	-0.10 (NA)	-0.10 (NA)	-0.20 (NA)
Potassium,Week 24,n=0,1,0,0,0	-0.10 (NA)
Potassium,Week 36,n=0,1,0,0,0	-0.20 (NA)
Sodium,Week 4,n=3,3,2,1,2	0.3 (1.53)	-1.0 (2.65)	-3.0 (2.83)	-3.0 (NA)	-1.0 (1.41)
Sodium,Week 8,n=2,1,2,0,2	-2.5 (0.71)	2.0 (NA)	-3.5 (3.54)	-1.0 (1.41)
Sodium,Week 12,n=1,1,1,1,1	-2.0 (NA)	1.0 (NA)	-4.0 (NA)	0.0 (NA)	-4.0 (NA)
Sodium,Week 16,n=0,1,1,1,0	0.0 (NA)	-4.0 (NA)	0.0 (NA)
Sodium,Week 24,n=0,1,0,0,0	3.0 (NA)
Sodium,Week 36,n=0,1,0,0,0	1.0 (NA)
Urea,Week 4,n=3,3,2,1,2	-0.83 (0.577)	-0.50 (1.323)	-0.50 (0.707)	0.00 (NA)	-0.25 (1.061)
Urea,Week 8,n=2,1,2,0,2	-0.50 (0.707)	0.00 (NA)	-0.75 (0.354)	0.50 (0.707)
Urea,Week 12,n=1,1,1,1,1	-0.50 (NA)	-1.50 (NA)	0.00 (NA)	-1.00 (NA)	-2.50 (NA)
Urea,Week 16,n=0,1,1,1,0	0.00 (NA)	-0.50 (NA)	0.50 (NA)
Urea,Week 24,n=0,1,0,0,0	-0.50 (NA)
Urea,Week 36,n=0,1,0,0,0	-1.00 (NA)

60. Secondary Outcome

Title	Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Albumin,Week 2,n=1,1,0,1,2	-1.0 (NA)	-1.0 (NA)	5.0 (NA)	3.5 (0.71)
Albumin,Week 4,n=2,1,1,2,2	0.0 (1.41)	0.0 (NA)	-1.0 (NA)	0.0 (2.83)	3.0 (1.41)
Albumin,Week 8,n=2,1,1,2,1	1.0 (2.83)	0.0 (NA)	0.0 (NA)	-2.0 (2.83)	2.0 (NA)
Albumin,Week 12,n=2,0,1,1,0	1.0 (0.00)	1.0 (NA)	-4.0 (NA)
Albumin,Week 14,n=0,0,0,1,0	0.0 (NA)
Albumin,Week 16,n=2,0,0,1,0	-0.5 (2.12)	2.0 (NA)
Albumin,Week 24,n=2,0,0,0,0	-0.5 (3.54)
Albumin,Week 36,n=2,0,0,0,0	-1.0 (2.83)
Albumin,Week 38,n=1,0,0,0,0	-2.0 (NA)
Albumin,Week 40,n=1,0,0,0,0	-2.0 (NA)
Protein,Week 2,n=1,1,0,1,2	0.0 (NA)	-1.0 (NA)	8.0 (NA)	1.5 (2.12)
Protein,Week 4,n=2,1,1,2,2	1.0 (1.41)	0.0 (NA)	-2.0 (NA)	-0.5 (4.95)	-0.5 (2.12)
Protein,Week 8,n=2,1,1,2,1	3.0 (1.41)	0.0 (NA)	2.0 (NA)	-2.5 (4.95)	0.0 (NA)
Protein,Week 12,n=2,0,1,1,0	2.5 (2.12)	2.0 (NA)	-4.0 (NA)
Protein,Week 14,n=0,0,0,1,0	-5.0 (NA)
Protein,Week 16,n=2,0,0,1,0	1.0 (1.41)	-2.0 (NA)
Protein,Week 24,n=2,0,0,0,0	0.5 (3.54)
Protein,Week 36,n=2,0,0,0,0	1.5 (0.71)
Protein,Week 38,n=1,0,0,0,0	1.0 (NA)
Protein,Week 40,n=1,0,0,0,0	0.0 (NA)

61. Secondary Outcome

Title	Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
Albumin,Week 4,n=3,3,2,1,2	-0.3 (1.53)	-1.3 (0.58)	1.0 (1.41)	0.0 (NA)	-2.5 (0.71)
Albumin,Week 8,n=2,1,2,0,2	1.5 (2.12)	-2.0 (NA)	1.0 (2.83)	-1.5 (0.71)
Albumin,Week 12,n=1,1,1,1,1	3.0 (NA)	-1.0 (NA)	5.0 (NA)	3.0 (NA)	0.0 (NA)
Albumin,Week 16,n=0,1,1,1,0	-2.0 (NA)	5.0 (NA)	0.0 (NA)
Albumin,Week 24,n=0,1,0,0,0	-1.0 (NA)
Albumin,Week 36,n=0,1,0,0,0	-2.0 (NA)
Protein,Week 4,n=3,3,2,1,2	-0.3 (3.21)	-2.7 (1.53)	1.0 (5.66)	0.0 (NA)	-5.0 (2.83)
Protein,Week 8,n=2,1,2,0,2	1.5 (3.54)	-2.0 (NA)	2.5 (4.95)	-1.5 (3.54)
Protein,Week 12,n=1,1,1,1,1	3.0 (NA)	-2.0 (NA)	9.0 (NA)	1.0 (NA)	2.0 (NA)
Protein,Week 16,n=0,1,1,1,0	-2.0 (NA)	12.0 (NA)	-1.0 (NA)
Protein,Week 24,n=0,1,0,0,0	-1.0 (NA)
Protein,Week 36,n=0,1,0,0,0	-2.0 (NA)

62. Secondary Outcome

Title	Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
ALT,Week 2,n=1,1,0,1,2	1.0 (NA)	4.0 (NA)	3.0 (NA)	72.5 (101.12)
ALT,Week 4,n=2,1,1,2,2	-1.5 (3.54)	4.0 (NA)	0.0 (NA)	4.0 (9.90)	51.5 (64.35)
ALT,Week 8,n=2,1,1,2,2	2.5 (4.95)	2.0 (NA)	1.0 (NA)	4.5 (7.78)	31.5 (24.75)
ALT,Week 12,n=2,0,1,1,0	-3.0 (7.07)	4.0 (NA)	-3.0 (NA)
ALT,Week 14,n=0,0,0,1,0	2.0 (NA)
ALT,Week 16,n=2,0,0,1,0	-1.0 (2.83)	2.0 (NA)
ALT,Week 24,n=2,0,0,0,0	-2.5 (6.36)
ALT,Week 36,n=2,0,0,0,0	-4.5 (9.19)
ALT,Week 38,n=1,0,0,0,0	-9.0 (NA)
ALT,Week 40,n=1,0,0,0,0	-9.0 (NA)
ALP,Week 2,n=1,1,0,1,2	7.0 (NA)	-2.0 (NA)	-17.0 (NA)	-5.0 (5.66)
ALP,Week 4,n=2,1,1,2,2	5.5 (0.71)	-9.0 (NA)	-4.0 (NA)	-9.0 (14.14)	-7.0 (5.66)
ALP,Week 8,n=2,1,1,2,2	7.0 (1.41)	-16.0 (NA)	-3.0 (NA)	-4.5 (26.16)	-12.0 (5.66)
ALP,Week 12,n=2,0,1,1,0	5.0 (1.41)	2.0 (NA)	8.0 (NA)
ALP,Week 14,n=0,0,0,1,0	-15.0 (NA)
ALP,Week 16,n=2,0,0,1,0	-0.5 (0.71)	-9.0 (NA)
ALP,Week 24,n=2,0,0,0,0	2.5 (2.12)
ALP,Week 36,n=2,0,0,0,0	2.0 (5.66)
ALP,Week 38,n=1,0,0,0,0	7.0 (NA)
ALP,Week 40,n=1,0,0,0,0	18.0 (NA)
AST,Week 2,n=1,1,0,1,2	0.0 (NA)	0.0 (NA)	3.0 (NA)	44.5 (57.28)
AST,Week 4,n=2,1,1,2,2	-4.5 (0.71)	0.0 (NA)	0.0 (NA)	-0.5 (3.54)	23.0 (25.46)
AST,Week 8,n=2,1,1,2,2	1.5 (0.71)	-2.0 (NA)	-3.0 (NA)	2.0 (4.24)	14.0 (5.66)
AST,Week 12,n=2,0,1,1,0	-4.0 (1.41)	-1.0 (NA)	-2.0 (NA)
AST,Week 14,n=0,0,0,1,0	0.0 (NA)
AST,Week 16,n=2,0,0,1,0	-3.0 (2.83)	1.0 (NA)
AST,Week 24,n=2,0,0,0,0	-3.5 (2.12)
AST,Week 36,n=2,0,0,0,0	-4.5 (4.95)
AST,Week 38,n=1,0,0,0,0	-7.0 (NA)
AST,Week 40,n=1,0,0,0,0	-7.0 (NA)

63. Secondary Outcome

Title	Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
ALT,Week 4,n=3,3,2,1,2	2.3 (1.15)	2.7 (7.23)	-8.0 (4.24)	103.0 (NA)	1.0 (0.00)
ALT,Week 8,n=2,1,2,0,2	9.0 (7.07)	13.0 (NA)	-9.5 (9.19)	-1.5 (3.54)
ALT,Week 12,n=1,1,1,1,1	3.0 (NA)	8.0 (NA)	-4.0 (NA)	0.0 (NA)	2.0 (NA)
ALT,Week 16,n=0,1,1,1,0	-5.0 (NA)	-6.0 (NA)	1.0 (NA)
ALT,Week 24,n=0,1,0,0,0	0.0 (NA)
ALT,Week 36,n=0,1,0,0,0	-4.0 (NA)
ALP,Week 4,n=3,3,2,1,2	-0.7 (3.79)	0.0 (4.36)	0.5 (3.54)	81.0 (NA)	0.0 (14.14)
ALP,Week 8,n=2,1,2,0,2	1.5 (2.12)	-1.0 (NA)	-1.0 (4.24)	-3.0 (0.00)
ALP,Week 12,n=1,1,1,1,1	-1.0 (NA)	0.0 (NA)	17.0 (NA)	-11.0 (NA)	-10.0 (NA)
ALP,Week 16,n=0,1,1,1,0	4.0 (NA)	3.0 (NA)	-10.0 (NA)
ALP,Week 24,n=0,1,0,0,0	2.0 (NA)
ALP,Week 36,n=0,1,0,0,0	4.0 (NA)
AST,Week 4,n=3,3,2,1,2	0.7 (1.53)	2.0 (3.00)	-5.0 (1.41)	24.0 (NA)	-1.5 (3.54)
AST,Week 8,n=2,1,2,0,2	10.5 (9.19)	7.0 (NA)	-6.0 (2.83)	0.0 (5.66)
AST,Week 12,n=1,1,1,1,1	1.0 (NA)	-1.0 (NA)	2.0 (NA)	0.0 (NA)	2.0 (NA)
AST,Week 16,n=0,1,1,1,0	-4.0 (NA)	0.0 (NA)	2.0 (NA)
AST,Week 24,n=0,1,0,0,0	-1.0 (NA)
AST,Week 36,n=0,1,0,0,0	-3.0 (NA)

64. Secondary Outcome

Title	Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time Frame	Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Bilirubin,Week 2,n=1,1,0,1,2	0.0 (NA)	0.0 (NA)	2.0 (NA)	-1.0 (1.41)
Bilirubin,Week 4,n=2,1,1,2,2	5.0 (1.41)	-2.0 (NA)	0.0 (NA)	1.0 (1.41)	1.0 (1.41)
Bilirubin,Week 8,n=2,1,1,2,2	-1.0 (4.24)	0.0 (NA)	2.0 (NA)	1.0 (4.24)	2.0 (0.00)
Bilirubin,Week 12,n=2,0,1,1,0	0.0 (8.49)	0.0 (NA)	-2.0 (NA)
Bilirubin,Week 14,n=0,0,0,1,0	0.0 (NA)
Bilirubin,Week 16,n=2,0,0,1,0	5.0 (4.24)	2.0 (NA)
Bilirubin,Week 24,n=2,0,0,0,0	-2.0 (5.66)
Bilirubin,Week 36,n=2,0,0,0,0	1.0 (7.07)
Bilirubin,Week 38,n=1,0,0,0,0	0.0 (NA)
Bilirubin,Week 40,n=1,0,0,0,0	2.0 (NA)
Direct Bilirubin,Week 2,n=1,1,0,1,2	0.0 (NA)	0.0 (NA)	2.0 (NA)	0.0 (0.00)
Direct Bilirubin,Week 4,n=2,1,1,2,2	1.0 (1.41)	0.0 (NA)	0.0 (NA)	1.0 (1.41)	0.0 (0.00)
Direct Bilirubin,Week 8,n=2,1,1,2,1	0.0 (2.83)	0.0 (NA)	0.0 (NA)	1.0 (1.41)	0.0 (NA)
Direct Bilirubin,Week 12,n=2,0,1,1,0	0.0 (2.83)	0.0 (NA)	0.0 (NA)
Direct Bilirubin,Week 14,n=0,0,0,1,0	0.0 (NA)
Direct Bilirubin,Week 16,n=2,0,0,1,0	1.0 (1.41)	0.0 (NA)
Direct Bilirubin,Week 24,n=2,0,0,0,0	0.0 (0.00)
Direct Bilirubin,Week 36,n=2,0,0,0,0	-1.0 (1.41)
Direct Bilirubin,Week 38,n=1,0,0,0,0	0.0 (NA)
Direct Bilirubin,Week 40,n=1,0,0,0,0	0.0 (NA)
Indirect Bilirubin,Week 2,n=1,1,0,1,2	0.0 (NA)	0.0 (NA)	0.0 (NA)	-1.0 (1.41)
Indirect Bilirubin,Week 4,n=2,1,1,2,2	4.0 (0.00)	-2.0 (NA)	0.0 (NA)	0.0 (0.00)	1.0 (1.41)
Indirect Bilirubin,Week 8,n=2,1,1,2,1	-1.0 (1.41)	0.0 (NA)	2.0 (NA)	0.0 (2.83)	2.0 (NA)
Indirect Bilirubin,Week 12,n=2,0,1,1,0	0.0 (5.66)	0.0 (NA)	-2.0 (NA)
Indirect Bilirubin,Week 14,n=0,0,0,1,0	0.0 (NA)
Indirect Bilirubin,Week 16,n=2,0,0,1,0	4.0 (5.66)	2.0 (NA)
Indirect Bilirubin,Week 24,n=2,0,0,0,0	-2.0 (5.66)
Indirect Bilirubin,Week 36,n=2,0,0,0,0	2.0 (8.49)
Indirect Bilirubin,Week 38,n=1,0,0,0,0	0.0 (NA)
Indirect Bilirubin,Week 40,n=1,0,0,0,0	2.0 (NA)
Creatinine,Week 2,n=1,1,0,1,2	-3.50 (NA)	-6.20 (NA)	1.80 (NA)	3.10 (1.838)
Creatinine,Week 4,n=2,1,1,2,2	-11.05 (9.405)	-12.40 (NA)	2.70 (NA)	-1.30 (0.566)	2.20 (4.384)
Creatinine,Week 8,n=2,1,1,2,1	-8.40 (6.930)	-8.00 (NA)	9.70 (NA)	0.45 (5.728)	0.00 (NA)
Creatinine,Week 12,n=2,0,1,1,0	-11.90 (11.879)	4.40 (NA)	-0.90 (NA)
Creatinine,Week 14,n=0,0,0,1,0	0.80 (NA)
Creatinine,Week 16,n=2,0,0,1,0	-12.80 (5.657)	4.40 (NA)
Creatinine,Week 24,n=2,0,0,0,0	-9.75 (12.516)
Creatinine,Week 36,n=2,0,0,0,0	-15.05 (9.970)
Creatinine,Week 38,n=1,0,0,0,0	-19.40 (NA)
Creatinine,Week 40,n=1,0,0,0,0	-20.30 (NA)

65. Secondary Outcome

Title	Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

Outcome Measure Data

Analysis Population Description

Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartBSIR 100 mg SC q2w+6 Month Prednisone	PartBSIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartBPlacebo SC q2w + 6 Month Prednisone	PartBPlacebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
Bilirubin,Week 4,n=3,3,2,1,2	0.7 (3.06)	1.3 (3.06)	-5.0 (1.41)	0.0 (NA)	-8.0 (2.83)
Bilirubin,Week 8,n=2,1,2,0,2	3.0 (4.24)	2.0 (NA)	-4.0 (2.83)	-6.0 (5.66)
Bilirubin,Week 12,n=1,1,1,1,1	4.0 (NA)	-2.0 (NA)	2.0 (NA)	4.0 (NA)	-8.0 (NA)
Bilirubin,Week 16,n=0,1,1,1,0	-2.0 (NA)	-2.0 (NA)	4.0 (NA)
Bilirubin,Week 24,n=0,1,0,0,0	-2.0 (NA)
Bilirubin,Week 36,n=0,1,0,0,0	-4.0 (NA)
Direct Bilirubin,Week 4,n=3,3,2,1,2	0.0 (0.00)	0.0 (0.00)	0.0 (0.00)	0.0 (NA)	-2.0 (0.00)
Direct Bilirubin,Week 8,n=2,1,2,0,2	1.0 (1.41)	2.0 (NA)	0.0 (0.00)	-2.0 (0.00)
Direct Bilirubin,Week 12,n=1,1,1,1,1	2.0 (NA)	2.0 (NA)	0.0 (NA)	0.0 (NA)	-2.0 (NA)
Direct Bilirubin,Week 16,n=0,1,1,1,0	0.0 (NA)	0.0 (NA)	0.0 (NA)
Direct Bilirubin,Week 24,n=0,1,0,0,0	0.0 (NA)
Direct Bilirubin,Week 36,n=0,1,0,0,0	0.0 (NA)
Indirect Bilirubin,Week 4,n=3,3,2,1,2	0.7 (3.06)	1.3 (3.06)	-5.0 (1.41)	0.0 (NA)	-6.0 (2.83)
Indirect Bilirubin,Week 8,n=2,1,2,0,2	2.0 (2.83)	0.0 (NA)	-4.0 (2.83)	-4.0 (5.66)
Indirect Bilirubin,Week 12,n=1,1,1,1,1	2.0 (NA)	-4.0 (NA)	2.0 (NA)	4.0 (NA)	-6.0 (NA)
Indirect Bilirubin,Week 16,n=0,1,1,1,0	-2.0 (NA)	-2.0 (NA)	4.0 (NA)
Indirect Bilirubin,Week 24,n=0,1,0,0,0	-2.0 (NA)
Indirect Bilirubin,Week 36,n=0,1,0,0,0	-4.0 (NA)
Creatinine,Week 4,n=3,3,2,1,2	-7.07 (7.887)	-0.63 (4.842)	-1.30 (9.334)	-0.90 (NA)	3.95 (19.445)
Creatinine,Week 8,n=2,1,2,0,2	-8.40 (0.566)	-18.60 (NA)	-5.25 (3.748)	-5.75 (5.728)
Creatinine,Week 12,n=1,1,1,1,1	-6.20 (NA)	-27.40 (NA)	5.30 (NA)	9.70 (NA)	-19.50 (NA)
Creatinine,Week 16,n=0,1,1,1,0	-19.50 (NA)	5.30 (NA)	5.30 (NA)
Creatinine,Week 24,n=0,1,0,0,0	-27.40 (NA)
Creatinine,Week 36,n=0,1,0,0,0	-21.20 (NA)

66. Secondary Outcome

Title	Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Description	Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented.
Time Frame	Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38

Outcome Measure Data

Analysis Population Description

ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Week 2, n=0,0,0,1,1	561.000 (NA)	550.000 (NA)
Week 4,n=0,0,0,2,1	596.125 (586.7219)	775.000 (NA)
Week 8,n=0,0,0,2,0	956.125 (851.8869)
Week 12,n=0,0,0,2,1	1201.125 (1000.3793)	1600.000 (NA)
Week 14,n=0,0,0,1,0	843.750 (NA)
Week 16,n=0,0,0,1,0	1233.750 (NA)
Week 24,n=0,0,0,1,0	1853.750 (NA)
Week 28,n=0,0,0,1,0	1908.500 (NA)
Week 32,n=0,0,0,0,1	1600.000 (NA)
Week 38,n=0,0,0,1,0	2153.750 (NA)

67. Secondary Outcome

Title	Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Description	Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time Frame	Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38

Outcome Measure Data

Analysis Population Description

ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartBSIR 100 mg SC q2w+6 Month Prednisone	PartBSIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartBPlacebo SC q2w + 6 Month Prednisone	PartBPlacebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	3	2
Week 4,n=0,0,0,1,1	203.750 (NA)	325.000 (NA)
Week 8,n=0,0,0,1,1	357.500 (NA)	596.250 (NA)
Week 12,n=0,0,0,0,1	830.000 (NA)
Week 16,n=0,0,0,0,1	1020.000 (NA)
Week 24,n=0,0,0,1,0	397.500 (NA)
Week 32,n=0,0,0,0,1	1211.250 (NA)

68. Secondary Outcome

Title	Part B: Number of Disease Flares Over Time
Description	This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented.
Time Frame	Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	8	5	4	5	4
Week 2, n=1,1,0,1,2	0	0	0	0
Week 4, n=5,4,4,3,4	0	0	0	0	0
Week 8, n=4,2,3,2,3	0	0	1	0	0
Week 12, n=3,2,2,2,1	0	0	1	0	0
Week 14, n=0,0,0,1,0	1
Week 16, n=2,1,1,2,0	0	0	0	1
Week 24, n=2,1,0,0,0	0	0
Week 36, n=2,1,0,0,0	0	0
Week 38, n=1,0,0,0,0	2
Week 40, n=1,0,0,0,0	2

69. Secondary Outcome

Title	Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare
Description	Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: "Severe Flare including Hospitalizations". Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.
Time Frame	Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

ITT-Part B Population.

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	8	5	4	5	4
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%

70. Secondary Outcome

Title	Part B: Number of Hospitalizations for Disease Flare Over Time
Description	Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: "Severe Flare including Hospitalizations". Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.
Time Frame	Up to Week 104

Outcome Measure Data

Analysis Population Description

ITT-Part B Population.

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	8	5	4	5	4
Number [Number of hospitalizations]	0	0	0	0	0

71. Secondary Outcome

Title	Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Description	SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who received at least one dose of 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	2	1	1	2	2
Par 1, Week 12, Physical Functioning	-10	NA	NA	NA	NA
Par 1, Week 12, Role Physical	-12.5	NA	NA	NA	NA
Par 1, Week 12, Bodily Pain	-39	NA	NA	NA	NA
Par 1, Week 12, General Health	0	NA	NA	NA	NA
Par 1, Week 12, Vitality	-6.25	NA	NA	NA	NA
Par 1, Week 12, Social Functioning	0	NA	NA	NA	NA
Par 1, Week 12, Role Emotional	-8.33	NA	NA	NA	NA
Par 1, Week 12, Mental Health	10	NA	NA	NA	NA
Par 1, Week 12, Physical Component Summary	-8.76	NA	NA	NA	NA
Par 1, Week 12, Mental Component Summary	3.29	NA	NA	NA	NA
Par 1, Week 24, Physical Functioning	-4.99	NA	NA	NA	NA
Par 1, Week 24, Role Physical	-12.5	NA	NA	NA	NA
Par 1, Week 24, Bodily Pain	1	NA	NA	NA	NA
Par 1, Week 24, General Health	-5	NA	NA	NA	NA
Par 1, Week 24, Vitality	0	NA	NA	NA	NA
Par 1, Week 24, Social Functioning	0	NA	NA	NA	NA
Par 1, Week 24, Role Emotional	-16.67	NA	NA	NA	NA
Par 1, Week 24, Mental Health	5	NA	NA	NA	NA
Par 1, Week 24, Physical Component Summary	-2.09	NA	NA	NA	NA
Par 1, Week 24, Mental Component Summary	-0.76	NA	NA	NA	NA
Par 1, Day 339, Physical Functioning	9.99	NA	NA	NA	NA
Par 1, Day 339, Role Physical	37.5	NA	NA	NA	NA
Par 1, Day 339, Bodily Pain	23	NA	NA	NA	NA
Par 1, Day 339, General Health	5	NA	NA	NA	NA
Par 1, Day 339, Vitality	6.25	NA	NA	NA	NA
Par 1, Day 339, Social Functioning	0	NA	NA	NA	NA
Par 1, Day 339, Role Emotional	0	NA	NA	NA	NA
Par 1, Day 339, Mental Health	0	NA	NA	NA	NA
Par 1, Day 339, Physical Component Summary	9.98	NA	NA	NA	NA
Par 1, Day 339, Mental Component Summary	-2.78	NA	NA	NA	NA
Par 2, Week 12, Physical Functioning	4.99	NA	NA	NA	NA
Par 2, Week 12, Role Physical	50	NA	NA	NA	NA
Par 2, Week 12, Bodily Pain	49	NA	NA	NA	NA
Par 2, Week 12, General Health	10	NA	NA	NA	NA
Par 2, Week 12, Vitality	0	NA	NA	NA	NA
Par 2, Week 12, Social Functioning	12.5	NA	NA	NA	NA
Par 2, Week 12, Role Emotional	NA	NA	NA	NA	NA
Par 2, Week 12, Mental Health	-10	NA	NA	NA	NA
Par 2, Week 12, Physical Component Summary	15.7	NA	NA	NA	NA
Par 2, Week 12, Mental Component Summary	-5.84	NA	NA	NA	NA
Par 2, Week 24, Physical Functioning	24.99	NA	NA	NA	NA
Par 2, Week 24, Role Physical	50	NA	NA	NA	NA
Par 2, Week 24, Bodily Pain	33	NA	NA	NA	NA
Par 2, Week 24, General Health	5	NA	NA	NA	NA
Par 2, Week 24, Vitality	-6.25	NA	NA	NA	NA
Par 2, Week 24, Social Functioning	12.5	NA	NA	NA	NA
Par 2, Week 24, Role Emotional	0	NA	NA	NA	NA
Par 2, Week 24, Mental Health	-20	NA	NA	NA	NA
Par 2, Week 24, Physical Component Summary	17.37	NA	NA	NA	NA
Par 2, Week 24, Mental Component Summary	-10.18	NA	NA	NA	NA
Par 2, Day 344, Physical Functioning	-5.01	NA	NA	NA	NA
Par 2, Day 344, Role Physical	37.5	NA	NA	NA	NA
Par 2, Day 344, Bodily Pain	11	NA	NA	NA	NA
Par 2, Day 344, General Health	10	NA	NA	NA	NA
Par 2, Day 344, Vitality	-6.25	NA	NA	NA	NA
Par 2, Day 344, Social Functioning	12.5	NA	NA	NA	NA
Par 2, Day 344, Role Emotional	0	NA	NA	NA	NA
Par 2, Day 344, Mental Health	-15	NA	NA	NA	NA
Par 2, Day 344, Physical Component Summary	8.12	NA	NA	NA	NA
Par 2, Day 344, Mental Component Summary	-4.89	NA	NA	NA	NA
Par 3, Day 113, Physical Functioning	NA	-10	NA	NA	NA
Par 3, Day 113, Role Physical	NA	0	NA	NA	NA
Par 3, Day 113, Bodily Pain	NA	0	NA	NA	NA
Par 3, Day 113, General Health	NA	-5	NA	NA	NA
Par 3, Day 113, Vitality	NA	-6.25	NA	NA	NA
Par 3, Day 113, Social Functioning	NA	NA	NA	NA	NA
Par 3, Day 113, Role Emotional	NA	0	NA	NA	NA
Par 3, Day 113, Mental Health	NA	-5	NA	NA	NA
Par 3, Day 113, Physical Component Summary	NA	-1.72	NA	NA	NA
Par 3, Day 113, Mental Component Summary	NA	-1.05	NA	NA	NA
Par 4, Week 12, Physical Functioning	NA	NA	15	NA	NA
Par 4, Week 12, Role Physical	NA	NA	6.25	NA	NA
Par 4, Week 12, Bodily Pain	NA	NA	33	NA	NA
Par 4, Week 12, General Health	NA	NA	-5	NA	NA
Par 4, Week 12, Vitality	NA	NA	0	NA	NA
Par 4, Week 12, Social Functioning	NA	NA	0	NA	NA
Par 4, Week 12, Role Emotional	NA	NA	0	NA	NA
Par 4, Week 12, Mental Health	NA	NA	5	NA	NA
Par 4, Week 12, Physical Component Summary	NA	NA	6.28	NA	NA
Par 4, Week 12, Mental Component Summary	NA	NA	-1.59	NA	NA
Par 5, Week 12, Physical Functioning	NA	NA	NA	5	NA
Par 5, Week 12, Role Physical	NA	NA	NA	-18.75	NA
Par 5, Week 12, Bodily Pain	NA	NA	NA	-16	NA
Par 5, Week 12, General Health	NA	NA	NA	10	10
Par 5, Week 12, Vitality	NA	NA	NA	6.25	NA
Par 5, Week 12, Social Functioning	NA	NA	NA	-25	NA
Par 5, Week 12, Role Emotional	NA	NA	NA	-16.66	NA
Par 5, Week 12, Mental Health	NA	NA	NA	-5	NA
Par 5, Week 12, Physical Component Summary	NA	NA	NA	-0.34	NA
Par 5, Week 12, Mental Component Summary	NA	NA	NA	-5.35	NA
Par 5, Day 162, Physical Functioning	NA	NA	NA	10.01	NA
Par 5, Day 162, Role Physical	NA	NA	NA	-18.75	NA
Par 5, Day 162, Bodily Pain	NA	NA	NA	-16	NA
Par 5, Day 162, General Health	NA	NA	NA	-7	NA
Par 5, Day 162, Vitality	NA	NA	NA	-12.5	NA
Par 5, Day 162, Social Functioning	NA	NA	NA	-25	NA
Par 5, Day 162, Role Emotional	NA	NA	NA	-33.33	NA
Par 5, Day 162, Mental Health	NA	NA	NA	5	NA
Par 5, Day 162, Physical Component Summary	168	NA	NA	-1.62	NA
Par 5, Day 162, Mental Component Summary	NA	NA	NA	-8.24	NA
Par 6, Day 91, Physical Functioning	NA	NA	NA	-15	NA
Par 6, Day 91, Role Physical	NA	NA	NA	-25	NA
Par 6, Day 91, Bodily Pain	NA	NA	NA	22	NA
Par 6, Day 91, General Health	NA	NA	NA	0	NA
Par 6, Day 91, Vitality	NA	NA	NA	-6.25	NA
Par 6, Day 91, Social Functioning	NA	NA	NA	0	NA
Par 6, Day 91, Role Emotional	NA	NA	NA	0	NA
Par 6, Day 91, Mental Health	NA	NA	NA	20	NA
Par 6, Day 91, Physical Component Summary	NA	NA	NA	-5.17	NA
Par 6, Day 91, Mental Component Summary	NA	NA	NA	5.95	NA
Par 7, Day 85, Physical Functioning	NA	NA	NA	NA	-10.01
Par 7, Day 85, Role Physical	NA	NA	NA	NA	-6.25
Par 7, Day 85, Bodily Pain	NA	NA	NA	NA	-22
Par 7, Day 85, General Health	NA	NA	NA	NA	10
Par 7, Day 85, Vitality	NA	NA	NA	NA	-12.5
Par 7, Day 85, Social Functioning	NA	NA	NA	NA	NA
Par 7, Day 85, Role Emotional	NA	NA	NA	NA	NA
Par 7, Day 85, Mental Health	NA	NA	NA	NA	5
Par 7, Day 85, Physical Component Summary	NA	NA	NA	NA	-4.79
Par 7, Day 85, Mental Component Summary	NA	NA	NA	NA	1.82
Par 8, Day 87, Physical Functioning	NA	NA	NA	NA	0
Par 8, Day 87, Role Physical	NA	NA	NA	NA	6.25
Par 8, Day 87, Bodily Pain	NA	NA	NA	NA	21
Par 8, Day 87, General Health	NA	NA	NA	NA	0
Par 8, Day 87, Vitality	NA	NA	NA	NA	0
Par 8, Day 87, Social Functioning	NA	NA	NA	NA	12.5
Par 8, Day 87, Role Emotional	NA	NA	NA	NA	16.66
Par 8, Day 87, Mental Health	NA	NA	NA	NA	5
Par 8, Day 87, Physical Component Summary	NA	NA	NA	NA	1.52
Par 8, Day 87, Mental Component Summary	NA	NA	NA	NA	4.54

72. Secondary Outcome

Title	Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Description	SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who never received 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
Measure Participants	6	4	3	2	2
Par 1, Day 30, Physical Functioning	-5	NA	NA	NA	NA
Par 1, Day 30, Role Physical	0	NA	NA	NA	NA
Par 1, Day 30, Bodily Pain	-16	NA	NA	NA	NA
Par 1, Day 30, General health	10	NA	NA	NA	NA
Par 1, Day 30, Vitality	0	NA	NA	NA	NA
Par 1, Day 30, Social Functioning	0	NA	NA	NA	NA
Par 1, Day 30, Role emotional	0	NA	NA	NA	NA
Par 1, Day 30, Mental health	5	NA	NA	NA	NA
Par 1, Day 30, Physical Component Summary	-2.26	NA	NA	NA	NA
Par 1, Day 30, Mental Component Summary	2.26	NA	NA	NA	NA
Par 2, Day 29, Physical Functioning	0	NA	NA	NA	NA
Par 2, Day 29, Role Physical	0	NA	NA	NA	NA
Par 2, Day 29, Bodily Pain	0	NA	NA	NA	NA
Par 2, Day 29, General health	8	NA	NA	NA	NA
Par 2, Day 29, Vitality	6.25	NA	NA	NA	NA
Par 2, Day 29, Social Functioning	0	NA	NA	NA	NA
Par 2, Day 29, Role emotional	0	NA	NA	NA	NA
Par 2, Day 29, Mental health	10	NA	NA	NA	NA
Par 2, Day 29, Physical Component Summary	-0.12	NA	NA	NA	NA
Par 2, Day 29, Mental Component Summary	3.18	NA	NA	NA	NA
Par 3, Day 23, Physical Functioning	25	NA	NA	NA	NA
Par 3, Day 23, Role Physical	6.25	NA	NA	NA	NA
Par 3, Day 23, Bodily Pain	49	NA	NA	NA	NA
Par 3, Day 23, General health	10	NA	NA	NA	NA
Par 3, Day 23, Vitality	0	NA	NA	NA	NA
Par 3, Day 23, Social Functioning	0	NA	NA	NA	NA
Par 3, Day 23, Role emotional	0	NA	NA	NA	NA
Par 3, Day 23, Mental health	-5	NA	NA	NA	NA
Par 3, Day 23, Physical Component Summary	12.88	NA	NA	NA	NA
Par 3, Day 23, Mental Component Summary	-5.75	NA	NA	NA	NA
Par 4, Week 12, Physical Functioning	15	NA	NA	NA	NA
Par 4, Week 12, Role Physical	18.75	NA	NA	NA	NA
Par 4, Week 12, Bodily Pain	0	NA	NA	NA	NA
Par 4, Week 12, General health	0	NA	NA	NA	NA
Par 4, Week 12, Vitality	6.25	NA	NA	NA	NA
Par 4, Week 12, Social Functioning	0	NA	NA	NA	NA
Par 4, Week 12, Role emotional	0	NA	NA	NA	NA
Par 4, Week 12, Mental health	0	NA	NA	NA	NA
Par 4, Week 12, Physical Component Summary	4.88	NA	NA	NA	NA
Par 4, Week 12, Mental Component Summary	-1.45	NA	NA	NA	NA
Par 4, Day 113, Physical Functioning	15	NA	NA	NA	NA
Par 4, Day 113, Role Physical	0	NA	NA	NA	NA
Par 4, Day 113, Bodily Pain	0	NA	NA	NA	NA
Par 4, Day 113, General health	10	NA	NA	NA	NA
Par 4, Day 113, Vitality	0	NA	NA	NA	NA
Par 4, Day 113, Social Functioning	-12.5	NA	NA	NA	NA
Par 4, Day 113, Role emotional	0	NA	NA	NA	NA
Par 4, Day 113, Mental health	25	NA	NA	NA	NA
Par 4, Day 113, Physical Component Summary	0.77	NA	NA	NA	NA
Par 4, Day 113, Mental Component Summary	3.61	NA	NA	NA	NA
Par 5, Week 8, Physical Functioning	-5	NA	NA	NA	NA
Par 5, Week 8, Role Physical	0	NA	NA	NA	NA
Par 5, Week 8, Bodily Pain	10	NA	NA	NA	NA
Par 5, Week 8, General health	-10	NA	NA	NA	NA
Par 5, Week 8, Vitality	-6.25	NA	NA	NA	NA
Par 5, Week 8, Social Functioning	-12.5	NA	NA	NA	NA
Par 5, Week 8, Role emotional	16.67	NA	NA	NA	NA
Par 5, Week 8, Mental health	0	NA	NA	NA	NA
Par 5, Week 8, Physical Component Summary	-2.1	NA	NA	NA	NA
Par 5, Week 8, Mental Component Summary	1.1	NA	NA	NA	NA
Par 5, Day 85, Physical Functioning	5	NA	NA	NA	NA
Par 5, Day 85, Role Physical	-6.25	NA	NA	NA	NA
Par 5, Day 85, Bodily Pain	10	NA	NA	NA	NA
Par 5, Day 85, General health	-22	NA	NA	NA	NA
Par 5, Day 85, Vitality	-6.25	NA	NA	NA	NA
Par 5, Day 85, Social Functioning	-12.5	NA	NA	NA	NA
Par 5, Day 85, Role emotional	8.33	NA	NA	NA	NA
Par 5, Day 85, Mental health	10	NA	NA	NA	NA
Par 5, Day 85, Physical Component Summary	-3.17	NA	NA	NA	NA
Par 5, Day 85, Mental Component Summary	1.62	NA	NA	NA	NA
Par 6, Day 65, Physical Functioning	0	NA	NA	NA	NA
Par 6, Day 65, Role Physical	6.25	NA	NA	NA	NA
Par 6, Day 65, Bodily Pain	0	NA	NA	NA	NA
Par 6, Day 65, General health	0	NA	NA	NA	NA
Par 6, Day 65, Vitality	-6.25	NA	NA	NA	NA
Par 6, Day 65, Social Functioning	12.5	NA	NA	NA	NA
Par 6, Day 65, Role emotional	8.33	NA	NA	NA	NA
Par 6, Day 65, Mental health	0	NA	NA	NA	NA
Par 6, Day 65, Physical Component Summary	-0.01	NA	NA	NA	NA
Par 6, Day 65, Mental Component Summary	1.88	NA	NA	NA	NA
Par 7, Week 12, Physical Functioning	NA	0	NA	NA	NA
Par 7, Week 12, Role Physical	NA	6.25	NA	NA	NA
Par 7, Week 12, Bodily Pain	NA	16	NA	NA	NA
Par 7, Week 12, General health	NA	0	NA	NA	NA
Par 7, Week 12, Vitality	NA	-6.25	NA	NA	NA
Par 7, Week 12, Social Functioning	NA	0	NA	NA	NA
Par 7, Week 12, Role emotional	NA	0	NA	NA	NA
Par 7, Week 12, Mental health	NA	-5	NA	NA	NA
Par 7, Week 12, Physical Component Summary	NA	-3.33	NA	NA	NA
Par 7, Week 12, Mental Component Summary	NA	-2.88	NA	NA	NA
Par 7, Day 373, Physical Functioning	NA	15	NA	NA	NA
Par 7, Day 373, Role Physical	NA	6.25	NA	NA	NA
Par 7, Day 373, Bodily Pain	NA	16	NA	NA	NA
Par 7, Day 373, General health	NA	8	NA	NA	NA
Par 7, Day 373, Vitality	NA	0	NA	NA	NA
Par 7, Day 373, Social Functioning	NA	0	NA	NA	NA
Par 7, Day 373, Role emotional	NA	0	NA	NA	NA
Par 7, Day 373, Mental health	NA	-15	NA	NA	NA
Par 7, Day 373, Physical Component Summary	NA	7.95	NA	NA	NA
Par 7, Day 373, Mental Component Summary	NA	-6.1	NA	NA	NA
Par 8, Day 64, Physical Functioning	NA	5	NA	NA	NA
Par 8, Day 64, Role Physical	NA	-6.25	NA	NA	NA
Par 8, Day 64, Bodily Pain	NA	-22	NA	NA	NA
Par 8, Day 64, General health	NA	0	NA	NA	NA
Par 8, Day 64, Vitality	NA	-12.5	NA	NA	NA
Par 8, Day 64, Social Functioning	NA	0	NA	NA	NA
Par 8, Day 64, Role emotional	NA	25	NA	NA	NA
Par 8, Day 64, Mental health	NA	-15	NA	NA	NA
Par 8, Day 64, Physical Component Summary	NA	-3.24	NA	NA	NA
Par 8, Day 64, Mental Component Summary	NA	0.02	NA	NA	NA
Par 9, Day 29, Physical Functioning	NA	10	NA	NA	NA
Par 9, Day 29, Role Physical	NA	6.25	NA	NA	NA
Par 9, Day 29, Bodily Pain	NA	0	NA	NA	NA
Par 9, Day 29, General health	NA	-3	NA	NA	NA
Par 9, Day 29, Vitality	NA	0	NA	NA	NA
Par 9, Day 29, Social Functioning	NA	0	NA	NA	NA
Par 9, Day 29, Role emotional	NA	0	NA	NA	NA
Par 9, Day 29, Mental health	NA	-10	NA	NA	NA
Par 9, Day 29, Physical Component Summary	NA	3.22	NA	NA	NA
Par 9, Day 29, Mental Component Summary	NA	-3.68	NA	NA	NA
Par 10, Day 57, Physical Functioning	NA	0	NA	NA	NA
Par 10, Day 57, Role Physical	NA	12.5	NA	NA	NA
Par 10, Day 57, Bodily Pain	NA	0	NA	NA	NA
Par 10, Day 57, General health	NA	-5	NA	NA	NA
Par 10, Day 57, Vitality	NA	0	NA	NA	NA
Par 10, Day 57, Social Functioning	NA	12.5	NA	NA	NA
Par 10, Day 57, Role emotional	NA	0	NA	NA	NA
Par 10, Day 57, Mental health	NA	0	NA	NA	NA
Par 10, Day 57, Physical Component Summary	NA	0.95	NA	NA	NA
Par 10, Day 57, Mental Component Summary	NA	0.83	NA	NA	NA
Par 11, Week 12, Physical Functioning	NA	NA	-29.99	NA	NA
Par 11, Week 12, Role Physical	NA	NA	-18.75	NA	NA
Par 11, Week 12, Bodily Pain	NA	NA	0	NA	NA
Par 11, Week 12, General health	NA	NA	-13	NA	NA
Par 11, Week 12, Vitality	NA	NA	-6.25	NA	NA
Par 11, Week 12, Social Functioning	NA	NA	-25	NA	NA
Par 11, Week 12, Role emotional	NA	NA	0	NA	NA
Par 11, Week 12, Mental health	NA	NA	5	NA	NA
Par 11, Week 12, Physical Component Summary	NA	NA	-9.37	NA	NA
Par 11, Week 12, Mental Component Summary	NA	NA	1.44	NA	NA
Par 11, Day 163, Physical Functioning	NA	NA	-15.01	NA	NA
Par 11, Day 163, Role Physical	NA	NA	6.25	NA	NA
Par 11, Day 163, Bodily Pain	NA	NA	0	NA	NA
Par 11, Day 163, General health	NA	NA	-8	NA	NA
Par 11, Day 163, Vitality	NA	NA	0	NA	NA
Par 11, Day 163, Social Functioning	NA	NA	-37.5	NA	NA
Par 11, Day 163, Role emotional	NA	NA	9	NA	NA
Par 11, Day 163, Mental health	NA	NA	10	NA	NA
Par 11, Day 163, Physical Component Summary	NA	NA	-3.64	NA	NA
Par 11, Day 163, Mental Component Summary	NA	NA	-0.4	NA	NA
Par 12, Day 85, Physical Functioning	NA	NA	-5	NA	NA
Par 12, Day 85, Role Physical	NA	NA	-6.25	NA	NA
Par 12, Day 85, Bodily Pain	NA	NA	-11	NA	NA
Par 12, Day 85, General health	NA	NA	-5	NA	NA
Par 12, Day 85, Vitality	NA	NA	6.25	NA	NA
Par 12, Day 85, Social Functioning	NA	NA	0	NA	NA
Par 12, Day 85, Role emotional	NA	NA	-16.67	NA	NA
Par 12, Day 85, Mental health	NA	NA	5	NA	NA
Par 12, Day 85, Physical Component Summary	NA	NA	-2.76	NA	NA
Par 12, Day 85, Mental Component Summary	NA	NA	0.13	NA	NA
Par 13, Day 59, Physical Functioning	NA	NA	5	NA	NA
Par 13, Day 59, Role Physical	NA	NA	-12.5	NA	NA
Par 13, Day 59, Bodily Pain	NA	NA	0	NA	NA
Par 13, Day 59, General health	NA	NA	0	NA	NA
Par 13, Day 59, Vitality	NA	NA	0	NA	NA
Par 13, Day 59, Social Functioning	NA	NA	-12.5	NA	NA
Par 13, Day 59, Role emotional	NA	NA	0	NA	NA
Par 13, Day 59, Mental health	NA	NA	-25	NA	NA
Par 13, Day 59, Physical Component Summary	NA	NA	2.16	NA	NA
Par 13, Day 59, Mental Component Summary	NA	NA	-7.59	NA	NA
Par 14, Day 57, Physical Functioning	NA	NA	NA	-5.01	NA
Par 14, Day 57, Role Physical	NA	NA	NA	-18.75	NA
Par 14, Day 57, Bodily Pain	NA	NA	NA	-32	NA
Par 14, Day 57, General health	NA	NA	NA	10	NA
Par 14, Day 57, Vitality	NA	NA	NA	12.5	NA
Par 14, Day 57, Social Functioning	NA	NA	NA	-37.5	NA
Par 14, Day 57, Role emotional	NA	NA	NA	0	NA
Par 14, Day 57, Mental health	NA	NA	NA	15	NA
Par 14, Day 57, Physical Component Summary	NA	NA	NA	-7.54	NA
Par 14, Day 57, Mental Component Summary	NA	NA	NA	3.62	NA
Par 15, Day 169, Physical Functioning	NA	NA	NA	4.99	NA
Par 15, Day 169, Role Physical	NA	NA	NA	50	NA
Par 15, Day 169, Bodily Pain	NA	NA	NA	33	NA
Par 15, Day 169, General health	NA	NA	NA	5	NA
Par 15, Day 169, Vitality	NA	NA	NA	6.25	NA
Par 15, Day 169, Social Functioning	NA	NA	NA	25	NA
Par 15, Day 169, Role emotional	NA	NA	NA	50	NA
Par 15, Day 169, Mental health	NA	NA	NA	0	NA
Par 15, Day 169, Physical Component Summary	NA	NA	NA	7.93	NA
Par 15, Day 169, Mental Component Summary	NA	NA	NA	8.48	NA
Par 16, Week 12, Physical Functioning	NA	NA	NA	NA	5
Par 16, Week 12, Role Physical	NA	NA	NA	NA	6.25
Par 16, Week 12, Bodily Pain	NA	NA	NA	NA	28
Par 16, Week 12, General health	NA	NA	NA	NA	0
Par 16, Week 12, Vitality	NA	NA	NA	NA	-6.25
Par 16, Week 12, Social Functioning	NA	NA	NA	NA	0
Par 16, Week 12, Role emotional	NA	NA	NA	NA	0
Par 16, Week 12, Mental health	NA	NA	NA	NA	0
Par 16, Week 12, Physical Component Summary	NA	NA	NA	NA	5.1
Par 16, Week 12, Mental Component Summary	NA	NA	NA	NA	-2.52
Par 16, Day 112, Physical Functioning	NA	NA	NA	NA	0
Par 16, Day 112, Role Physical	NA	NA	NA	NA	12.5
Par 16, Day 112, Bodily Pain	NA	NA	NA	NA	28
Par 16, Day 112, General health	NA	NA	NA	NA	-20
Par 16, Day 112, Vitality	NA	NA	NA	NA	-6.25
Par 16, Day 112, Social Functioning	NA	NA	NA	NA	0
Par 16, Day 112, Role emotional	NA	NA	NA	NA	0
Par 16, Day 112, Mental health	NA	NA	NA	NA	0
Par 16, Day 112, Physical Component Summary	NA	NA	NA	NA	2.71
Par 16, Day 112, Mental Component Summary	NA	NA	NA	NA	-2.21
Par 17, Day 85, Physical Functioning	NA	NA	NA	NA	-10
Par 17, Day 85, Role Physical	NA	NA	NA	NA	-25
Par 17, Day 85, Bodily Pain	NA	NA	NA	NA	-10
Par 17, Day 85, General health	NA	NA	NA	NA	0
Par 17, Day 85, Vitality	NA	NA	NA	NA	6.25
Par 17, Day 85, Social Functioning	NA	NA	NA	NA	-12.5
Par 17, Day 85, Role emotional	NA	NA	NA	NA	0
Par 17, Day 85, Mental health	NA	NA	NA	NA	5
Par 17, Day 85, Physical Component Summary	NA	NA	NA	NA	-6.51
Par 17, Day 85, Mental Component Summary	NA	NA	NA	NA	3.01

73. Secondary Outcome

Title	Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Description	EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	2	1	1	2	2
Par 1, Week 12	-0.127	NA	NA	NA	NA
Par 1, Week 24	-0.098	NA	NA	NA	NA
Par 1, Day 339	-0.070	NA	NA	NA	NA
Par 2, Week 12	0.204	NA	NA	NA	NA
Par 2, Week 24	0.041	NA	NA	NA	NA
Par 2, Day 344	0.110	NA	NA	NA	NA
Par 3, Day 113	NA	0.000	NA	NA	NA
Par 4, Week 12	NA	NA	0.097	NA	NA
Par 5, Week 12	NA	NA	NA	0.028	NA
Par 5, Day 162	NA	NA	NA	0.028	NA
Par 6, Day 91	NA	NA	NA	0.000	NA
Par 7, Day 85	NA	NA	NA	NA	0.000
Par 8, Day 87	NA	NA	NA	NA	0.012

74. Secondary Outcome

Title	Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Description	EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	6	4	3	3	2
Par 1, Day 30	-0.248	NA	NA	NA	NA
Par 2, Day 29	0.000	NA	NA	NA	NA
Par 3, Day 29	0.233	NA	NA	NA	NA
Par 4, Week 12	0.000	NA	NA	NA	NA
Par 4, Day 113	0.000	NA	NA	NA	NA
Par 5, Day 85	-0.015	NA	NA	NA	NA
Par 6, Day 65	0.163	NA	NA	NA	NA
Par 7, Week 12	NA	0.163	NA	NA	NA
Par 7, Day 373	NA	0.163	NA	NA	NA
Par 8, Day 64	NA	-0.016	NA	NA	NA
Par 9, Day 29	NA	0.212	NA	NA	NA
Par 10, Day 57	NA	0.000	NA	NA	NA
Par 11, Week 12	NA	NA	-0.069	NA	NA
Par 11, Day 163	NA	NA	0.042	NA	NA
Par 12, Day 85	NA	NA	-0.059	NA	NA
Par 13, Day 59	NA	NA	0.000	NA	NA
Par 14, Day 57	NA	NA	NA	0.000	NA
Par 16, Day 169	NA	NA	NA	0.232	NA
Par 17,Week 12	NA	NA	NA	NA	0.163
Par 17, Day 112	NA	NA	NA	NA	0.163
Par 18, Day 85	NA	NA	NA	NA	-0.042

75. Secondary Outcome

Title	Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Description	The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	2	1	1	2	2
Par 1, Week 12, I Feel Fatigued	-3	NA	NA	NA	NA
Par 1, Week 24, I Feel Fatigued	-4	NA	NA	NA	NA
Par 1, Day 339, I Feel Fatigued	3	NA	NA	NA	NA
Par 2, Week 12, I Feel Fatigued	8	NA	NA	NA	NA
Par 2, Week 24, I Feel Fatigued	2	NA	NA	NA	NA
Par 2, Day 344, I Feel Fatigued	6	NA	NA	NA	NA
Par 3, Day 113, I Feel Fatigued	NA	2	NA	NA	NA
Par 4, Week 12, I Feel Fatigued	NA	NA	2	NA	NA
Par 5, Week 12, I Feel Fatigued	NA	NA	NA	-5	NA
Par 5, Day 162, I Feel Fatigued	NA	NA	NA	-4	NA
Par 6, Day 91, I Feel Fatigued	NA	NA	NA	-12	NA
Par 7, Day 85, I Feel Fatigued	NA	NA	NA	NA	-7
Par 8, Day 87, I Feel Fatigued	NA	NA	NA	NA	-10

76. Secondary Outcome

Title	Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Description	The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Time Frame	Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	6	4	3	3	2
Par 1, Day 30, I Feel Fatigued	-3	NA	NA	NA	NA
Par 2, Day 29, I Feel Fatigued	-1	NA	NA	NA	NA
Par 3, Day 23, I Feel Fatigued	0	NA	NA	NA	NA
Par 4, Week 12, I Feel Fatigued	2	NA	NA	NA	NA
Par 4, Day 113, I Feel Fatigued	-16	NA	NA	NA	NA
Par 5, Week 8, I Feel Fatigued	-1	NA	NA	NA	NA
Par 5, Day 85, I Feel Fatigued	-3	NA	NA	NA	NA
Par 6, Day 65, I Feel Fatigued	-1	NA	NA	NA	NA
Par 7, Week 12, I Feel Fatigued	NA	0	NA	NA	NA
Par 7, Day 373, I Feel Fatigued	NA	5	NA	NA	NA
Par 8, Day 64, I Feel Fatigued	NA	-3	NA	NA	NA
Par 9, Day 29, I Feel Fatigued	NA	0	NA	NA	NA
Par 10, Day 57, I Feel Fatigued	NA	13	NA	NA	NA
Par 11, Week 12, I Feel Fatigued	NA	NA	5	NA	NA
Par 11, Day 163, I Feel Fatigued	NA	NA	6	NA	NA
Par 12, Day 85, I Feel Fatigued	NA	NA	-1	NA	NA
Par 13, Day 59, I Feel Fatigued	NA	NA	7	NA	NA
Par 14, Day 57, I Feel Fatigued	NA	NA	NA	-11	NA
Par 16, Day 169, I Feel Fatigued	NA	NA	NA	0	NA
Par 17, Week 12, I Feel Fatigued	NA	NA	NA	NA	6
Par 17, Day112, I Feel Fatigued	NA	NA	NA	NA	6
Par 18, Day 85, I Feel Fatigued	NA	NA	NA	NA	-1

77. Secondary Outcome

Title	Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Description	The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	2	1	1	2	2
Par 1, Week 2	4	NA	NA	NA	NA
Par 1, Week 4	-1	NA	NA	NA	NA
Par 1, Week 8	-1	NA	NA	NA	NA
Par 1, Week 12	4	NA	NA	NA	NA
Par 1, Week 24	0	NA	NA	NA	NA
Par 1, Day 339	-2	NA	NA	NA	NA
Par 2, Week 4	0	NA	NA	NA	NA
Par 2, Week 8	0	NA	NA	NA	NA
Par 2, Week 12	1	0	NA	NA	NA
Par 2, Week 24	0	NA	NA	NA	NA
Par 2, Week 38	1	NA	NA	NA	NA
Par 2, Week 40	1	NA	NA	NA	NA
Par 2, Day 344	0	NA	NA	NA	NA
Par 3, Day 113	NA	-2	NA	NA	NA
Par 4, Week 4	NA	NA	-2	NA	NA
Par 4, Week 8	NA	NA	0	NA	NA
Par 4, Week 12	NA	NA	-3	NA	NA
Par 5, Week 4	NA	NA	NA	0	NA
Par 5, Week 8	NA	NA	NA	1	NA
Par 5, Week 12	NA	NA	NA	0	NA
Par 5, Week 14	NA	NA	NA	1	NA
Par 5, Week 16	NA	NA	NA	0	NA
Par 5, Day 162	NA	NA	NA	1	NA
Par 6, Week 2	NA	NA	NA	2	NA
Par 6, Week 4	NA	NA	NA	-2	NA
Par 6, Week 8	NA	NA	NA	-2	NA
Par 6, Day 91	NA	NA	NA	-1	NA
Par 7, Week 2	NA	NA	NA	NA	-1
Par 7, Week 4	NA	NA	NA	NA	0
Par 7, Week 8	NA	NA	NA	NA	1
Par 7, Day 85	NA	NA	NA	NA	0
Par 8, Week 2	NA	NA	NA	NA	2
Par 8, Week 4	NA	NA	NA	NA	0
Par 8, Day 87	NA	NA	NA	NA	0

78. Secondary Outcome

Title	Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Description	The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Time Frame	Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	6	4	3	3	2
Par 1, Day 30	0	NA	NA	NA	NA
Par 2, Day 29	0	NA	NA	NA	NA
Par 3, Day 23	-1	NA	NA	NA	NA
Par 4, Week 4	0	NA	NA	NA	NA
Par 4, Week 8	0	NA	NA	NA	NA
Par 4, Week 12	0	NA	NA	NA	NA
Par 4, Day 113	0	NA	NA	NA	NA
Par 5, Week 4	0	NA	NA	NA	NA
Par 5, Week 8	0	NA	NA	NA	NA
Par 5, Day 85	2	NA	NA	NA	NA
Par 6, Week 4	0	NA	NA	NA	NA
Par 6, Day 65	0	NA	NA	NA	NA
Par 7, Week 4	NA	1	NA	NA	NA
Par 7, Week 8	NA	0	NA	NA	NA
Par 7, Week 12	NA	0	NA	NA	NA
Par 7, Day 373	NA	0	NA	NA	NA
Par 8, Week 4	NA	0	NA	NA	NA
Par 8, Day 64	NA	-1	NA	NA	NA
Par 9, Day 29	NA	0	NA	NA	NA
Par 10, Week 4	NA	0	NA	NA	NA
Par 10, Day 57	NA	-1	NA	NA	NA
Par 11, Week 4	NA	NA	0	NA	NA
Par 11, Week 8	NA	NA	0	NA	NA
Par 11, Week 12	NA	NA	1	NA	NA
Par 11, Day 163	NA	NA	1	NA	NA
Par 12, Week 4	NA	NA	0	NA	NA
Par 12, Week 8	NA	NA	-1	NA	NA
Par 12, Day 85	NA	NA	0	NA	NA
Par 13, Week 4	NA	NA	0	NA	NA
Par 13, Day 59	NA	NA	0	NA	NA
Par 14, Week 4	NA	NA	NA	0	NA
Par 14, Day 57	NA	NA	NA	-1	NA
Par 16, Day 169	NA	NA	NA	-3	NA
Par 17, Week 4	NA	NA	NA	NA	-2
Par 17, Week 12	NA	NA	NA	NA	-2
Par 17, Day 112	NA	NA	NA	NA	-2
Par 18, Week 8	NA	NA	NA	NA	1
Par 18, Day 85	NA	NA	NA	NA	0

79. Secondary Outcome

Title	Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Description	Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability
Time Frame	Day 87, 339, 344, Week 12, 24

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	2	0	1	0	1
Par 1, Week 12, Able to Do Chores	1	NA	NA
Par 1, Week 12, Get In and Out of a car	0	NA	NA
Par 1, Week 12, Run Errands and Shop	0	NA	NA
Par 1, Week 12, Get In and Out of Bed	0	NA	NA
Par 1, Week 12, Stand Up From a Straight	1	NA	NA
Par 1, Week 12, Dress yourself	1	NA	NA
Par 1, Week 12, Shampoo your hair	0	NA	NA
Par 1, Week 12, Cut your meat	0	NA	NA
Par 1, Week 12, Lift a Full Cup/Glass to mouth	0	NA	NA
Par 1, Week 12, Open a New Milk Carton	1	NA	NA
Par 1, Week 12, Open car doors	0	NA	NA
Par 1, Week 12, Open Jars Previously Opened	1	NA	NA
Par 1, Week 12, Turn Faucets On And Off	1	NA	NA
Par 1, Week 12, Get On and Off The Toilet	0	NA	NA
Par 1, Week 12, Take a Tub Bath	3	NA	NA
Par 1, Week 12, Wash and Dry Your Body	0	NA	NA
Par 1, Week 12, Bend Down Pick Up Clothing-Floor	1	NA	NA
Par 1, Week 12, Reach-Get Down 5 Lb Obj Above Head	1	NA	NA
Par 1, Week 12, Climb Up Five Steps	0	NA	NA
Par 1, Week 12, Walk Outdoors on Flat Ground	0	NA	NA
Par 1, Week 24, Able to Do Chores	0	NA	NA
Par 1, Week 24, Get In and Out of a car	0	NA	NA
Par 1, Week 24, Run Errands and Shop	0	NA	NA
Par 1, Week 24, Get In and Out of Bed	0	NA	NA
Par 1, Week 24, Stand Up From a Straight	0	NA	NA
Par 1, Week 24, Dress yourself	0	NA	NA
Par 1, Week 24, Shampoo your hair	0	NA	NA
Par 1, Week 24, Cut your meat	0	NA	NA
Par 1, Week 24, Lift a Full Cup/Glass to mouth	0	NA	NA
Par 1, Week 24, Open a New Milk Carton	0	NA	NA
Par 1, Week 24, Open car doors	0	NA	NA
Par 1, Week 24, Open Jars Previously Opened	1	NA	NA
Par 1, Week 24, Turn Faucets On And Off	1	NA	NA
Par 1, Week 24, Get On and Off The Toilet	0	NA	NA
Par 1, Week 24, Take a Tub Bath	3	NA	NA
Par 1, Week 24, Wash and Dry Your Body	0	NA	NA
Par 1, Week 24, Bend Down Pick Up Clothing-Floor	0	NA	NA
Par 1, Week 24, Reach-Get Down 5 Lb Obj Above Head	0	NA	NA
Par 1, Week 24, Climb Up Five Steps	0	NA	NA
Par 1, Week 24, Walk Outdoors on Flat Ground	0	NA	NA
Par 1, Day 339, Able to Do Chores	0	NA	NA
Par 1, Day 339, Get In and Out of a car	0	NA	NA
Par 1, Day 339, Run Errands and Shop	0	NA	NA
Par 1, Day 339, Get In and Out of Bed	0	NA	NA
Par 1, Day 339, Stand Up From a Straight	0	NA	NA
Par 1, Day 339, Dress yourself	0	NA	NA
Par 1, Day 339, Shampoo your hair	0	NA	NA
Par 1, Day 339, Cut your meat	0	NA	NA
Par 1, Day 339, Lift a Full Cup/Glass to mouth	0	NA	NA
Par 1, Day 339, Open a New Milk Carton	1	NA	NA
Par 1, Day 339, Open car doors	0	NA	NA
Par 1, Day 339, Open Jars Previously Opened	0	NA	NA
Par 1, Day 339, Turn Faucets On And Off	0	NA	NA
Par 1, Day 339, Get On and Off The Toilet	0	NA	NA
Par 1, Day 339, Take a Tub Bath	3	NA	NA
Par 1, Day 339, Wash and Dry Your Body	0	NA	NA
Par 1, Day 339, Bend Down Pick Up Clothing-Floor	0	NA	NA
Par 1, Day 339, Reach-Get Down 5 Lb Obj Above Head	0	NA	NA
Par 1, Day 339, Climb Up Five Steps	0	NA	NA
Par 1, Day 339, Walk Outdoors on Flat Ground	0	NA	NA
Par 2, Week 12, Able to Do Chores	1	NA	NA
Par 2, Week 12, Get In and Out of a car	0	NA	NA
Par 2, Week 12, Run Errands and Shop	0	NA	NA
Par 2, Week 12, Get In and Out of Bed	0	NA	NA
Par 2, Week 12, Stand Up From a Straight	0	NA	NA
Par 2, Week 12, Dress yourself	0	NA	NA
Par 2, Week 12, Shampoo your hair	0	NA	NA
Par 2, Week 12, Cut your meat	0	NA	NA
Par 2, Week 12, Lift a Full Cup/Glass to mouth	0	NA	NA
Par 2, Week 12, Open a New Milk Carton	1	NA	NA
Par 2, Week 12, Open car doors	0	NA	NA
Par 2, Week 12, Open Jars Previously Opened	0	NA	NA
Par 2, Week 12, Turn Faucets On And Off	0	NA	NA
Par 2, Week 12, Get On and Off The Toilet	0	NA	NA
Par 2, Week 12, Take a Tub Bath	3	NA	NA
Par 2, Week 12, Wash and Dry Your Body	0	NA	NA
Par 2, Week 12, Bend Down Pick Up Clothing-Floor	1	NA	NA
Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head	2	NA	NA
Par 2, Week 12, Climb Up Five Steps	0	NA	NA
Par 2, Week 12, Walk Outdoors on Flat Ground	0	NA	NA
Par 2, Week 24, Able to Do Chores	0	NA	NA
Par 2, Week 24, Get In and Out of a car	0	NA	NA
Par 2, Week 24, Run Errands and Shop	0	NA	NA
Par 2, Week 24, Get In and Out of Bed	0	NA	NA
Par 2, Week 24, Stand Up From a Straight	0	NA	NA
Par 2, Week 24, Dress yourself	0	NA	NA
Par 2, Week 24, Shampoo your hair	0	NA	NA
Par 2, Week 24, Cut your meat	0	NA	NA
Par 2, Week 24, Lift a Full Cup/Glass to mouth	0	NA	NA
Par 2, Week 24, Open a New Milk Carton	0	NA	NA
Par 2, Week 24, Open car doors	0	NA	NA
Par 2, Week 24, Open Jars Previously Opened	0	NA	NA
Par 2, Week 24, Turn Faucets On And Off	0	NA	NA
Par 2, Week 24, Get On and Off The Toilet	0	NA	NA
Par 2, Week 24, Take a Tub Bath	0	NA	NA
Par 2, Week 24, Wash and Dry Your Body	0	NA	NA
Par 2, Week 24, Bend Down Pick Up Clothing-Floor	0	NA	NA
Par 2, Week 24, Reach-Get Down 5 Lb Obj Above Head	1	NA	NA
Par 2, Week 24, Climb Up Five Steps	0	NA	NA
Par 2, Week 24, Walk Outdoors on Flat Ground	0	NA	NA
Par 2, Day 344, Able to Do Chores	1	NA	NA
Par 2, Day 344, Get In and Out of a car	0	NA	NA
Par 2, Day 344, Run Errands and Shop	0	NA	NA
Par 2, Day 344, Get In and Out of Bed	0	NA	NA
Par 2, Day 344, Stand Up From a Straight	0	NA	NA
Par 2, Day 344, Dress yourself	0	NA	NA
Par 2, Day 344, Shampoo your hair	0	NA	NA
Par 2, Day 344, Cut your meat	0	NA	NA
Par 2, Day 344, Lift a Full Cup/Glass to mouth	0	NA	NA
Par 2, Day 344, Open a New Milk Carton	1	NA	NA
Par 2, Day 344, Open car doors	0	NA	NA
Par 2, Day 344,Open Jars Previously Opened	0	NA	NA
Par 2, Day 344, Turn Faucets On And Off	0	NA	NA
Par 2, Day 344, Get On and Off The Toilet	0	NA	NA
Par 2, Day 344, Take a Tub Bath	3	NA	NA
Par 2, Day 344, Wash and Dry Your Body	0	NA	NA
Par 2, Day 344, Bend Down Pick Up Clothing-Floor	0	NA	NA
Par 2, Day 344, Reach-Get Down 5 Lb Obj Above Head	1	NA	NA
Par 2, Day 344, Climb Up Five Steps	0	NA	NA
Par 2, Day 344, Walk Outdoors on Flat Ground	0	NA	NA
Par 3, Week 12, Able to Do Chores	NA	0	NA
Par 3, Week 12, Get In and Out of a car	NA	0	NA
Par 3, Week 12, Run Errands and Shop	NA	0	NA
Par 3, Week 12, Get In and Out of Bed	NA	0	NA
Par 3, Week 12, Stand Up From a Straight	NA	0	NA
Par 3, Week 12, Dress yourself	NA	0	NA
Par 3, Week 12, Shampoo your hair	NA	0	NA
Par 3, Week 12, Cut your meat	NA	0	NA
Par 3, Week 12, Lift a Full Cup/Glass to mouth	NA	0	NA
Par 3, Week 12, Open a New Milk Carton	NA	0	NA
Par 3, Week 12, Open car doors	NA	0	NA
Par 3, Week 12, Open Jars Previously Opened	NA	0	NA
Par 3, Week 12, Turn Faucets On And Off	NA	0	NA
Par 3, Week 12, Get On and Off The Toilet	NA	0	NA
Par 3, Week 12, Take a Tub Bath	NA	0	NA
Par 3, Week 12, Wash and Dry Your Body	NA	0	NA
Par 3, Week 12, Bend Down Pick Up Clothing-Floor	NA	0	NA
Par 3, Week 12, Reach-Get Down 5 Lb Obj Above Head	NA	0	NA
Par 3, Week 12, Climb Up Five Steps	NA	0	NA
Par 3, Week 12, Walk Outdoors on Flat Ground	NA	0	NA
Par 4, Day 87, Able to Do Chores	NA	NA	1
Par 4, Day 87, Get In and Out of a car	NA	NA	0
Par 4, Day 87, Run Errands and Shop	NA	NA	0
Par 4, Day 87, Get In and Out of Bed	NA	NA	0
Par 4, Day 87, Stand Up From a Straight	NA	NA	0
Par 4, Day 87, Dress yourself	NA	NA	0
Par 4, Day 87, Shampoo your hair	NA	NA	0
Par 4, Day 87, Cut your meat	NA	NA	0
Par 4, Day 87, Lift a Full Cup/Glass to mouth	NA	NA	0
Par 4, Day 87, Open a New Milk Carton	NA	NA	0
Par 4, Day 87, Open Jars Previously Opened	NA	NA	0
Par 4, Day 87, Turn Faucets On And Off	NA	NA	0
Par 4, Day 87, Get On and Off The Toilet	NA	NA	0
Par 4, Day 87, Take a Tub Bath	NA	NA	0
Par 4, Day 87, Wash and Dry Your Body	NA	NA	1
Par 4, Day 87, Bend Down Pick Up Clothing-Floor	NA	NA	0
Par 4, Day 87, Reach-Get Down 5 Lb Obj Above Head	NA	NA	1
Par 4, Day 87, Climb Up Five Steps	NA	NA	0
Par 4, Day 87, Walk Outdoors on Flat Ground	NA	NA	0

80. Secondary Outcome

Title	Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Description	Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability
Time Frame	Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	3	2	1	1	1
Par 1, Day 29, Able to Do Chores	0	NA	NA	NA	NA
Par 1, Day 29, Get In and Out of a car	0	NA	NA	NA	NA
Par 1, Day 29, Run Errands and Shop	0	NA	NA	NA	NA
Par 1, Day 29, Get In and Out of Bed	0	NA	NA	NA	NA
Par 1, Day 29, Stand Up From a Straight Chair	0	NA	NA	NA	NA
Par 1, Day 29, Dress yourself	0	NA	NA	NA	NA
Par 1, Day 29, Shampoo your hair	0	NA	NA	NA	NA
Par 1, Day 29, Cut your meat	0	NA	NA	NA	NA
Par 1, Day 29, Lift a Full Cup or Glass to Mouth	0	NA	NA	NA	NA
Par 1, Day 29, Open a New Milk Carton	0	NA	NA	NA	NA
Par 1, Day 29, Open car doors	0	NA	NA	NA	NA
Par 1, Day 29, Open Jars Previously Opened	0	NA	NA	NA	NA
Par 1, Day 29, Turn Faucets On And Off	0	NA	NA	NA	NA
Par 1, Day 29, Get On and Off The Toilet	0	NA	NA	NA	NA
Par 1, Day 29, Take a Tub Bath	0	NA	NA	NA	NA
Par 1, Day 29, Wash and Dry Your Body	0	NA	NA	NA	NA
Par 1, Day 29, Bend Down Pick Up Clothing- Floor	0	NA	NA	NA	NA
Par 1, Day 29, Reach-Get Down 5 Lb Obj Above Head	0	NA	NA	NA	NA
Par 1, Day 29, Climb Up Five Steps	0	NA	NA	NA	NA
Par 1, Day 29, Walk Outdoors on Flat Ground	0	NA	NA	NA	NA
Par 2, Week 12, Able to Do Chores	0	NA	NA	NA	NA
Par 2, Week 12, Get In and Out of a car	0	NA	NA	NA	NA
Par 2, Week 12, Run Errands and Shop	0	NA	NA	NA	NA
Par 2, Week 12, Get In and Out of Bed	0	NA	NA	NA	NA
Par 2, Week 12, Stand Up From a Straight Chair	0	NA	NA	NA	NA
Par 2, Week 12, Dress yourself	0	NA	NA	NA	NA
Par 2, Week 12, Shampoo your hair	0	NA	NA	NA	NA
Par 2, Week 12, Cut your meat	0	NA	NA	NA	NA
Par 2, Week 12, Lift a Full Cup or Glass to Mouth	0	NA	NA	NA	NA
Par 2, Week 12, Open a New Milk Carton	0	NA	NA	NA	NA
Par 2, Week 12, Open r car doors	0	NA	NA	NA	NA
Par 2, Week 12, Open Jars Previously Opened	0	NA	NA	NA	NA
Par 2, Week 12, Turn Faucets On And Off	0	NA	NA	NA	NA
Par 2, Week 12, Get On and Off The Toilet	0	NA	NA	NA	NA
Par 2, Week 12, Take a Tub Bath	0	NA	NA	NA	NA
Par 2, Week 12, Wash and Dry Your Body	0	NA	NA	NA	NA
Par 2, Week 12, Bend Down Pick Up Clothing- Floor	1	NA	NA	NA	NA
Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head	1	NA	NA	NA	NA
Par 2, Week 12, Climb Up Five Steps	0	NA	NA	NA	NA
Par 2, Week 12, Walk Outdoors on Flat Ground	0	NA	NA	NA	NA
Par 2, Day 113, Able to Do Chores	0	NA	NA	NA	NA
Par 2, Day 113, Get In and Out of a car	1	NA	NA	NA	NA
Par 2, Day 113, Run Errands and Shop	0	NA	NA	NA	NA
Par 2, Day 113, Get In and Out of Bed	0	NA	NA	NA	NA
Par 2, Day 113, Stand Up From a Straight Chair	1	NA	NA	NA	NA
Par 2, Day 113, Dress yourself	0	NA	NA	NA	NA
Par 2, Day 113, Shampoo your hair	0	NA	NA	NA	NA
Par 2, Day 113, Cut your meat	0	NA	NA	NA	NA
Par 2, Day 113, Lift a Full Cup or Glass to Mouth	0	NA	NA	NA	NA
Par 2, Day 113, Open a New Milk Carton	0	NA	NA	NA	NA
Par 2, Day 113, Open car doors	0	NA	NA	NA	NA
Par 2, Day 113, Open Jars Previously Opened	0	NA	NA	NA	NA
Par 2, Day 113, Turn Faucets On And Off	0	NA	NA	NA	NA
Par 2, Day 113, Get On and Off The Toilet	0	NA	NA	NA	NA
Par 2, Day 113, Take a Tub Bath	0	NA	NA	NA	NA
Par 2, Day 113, Wash and Dry Your Body	0	NA	NA	NA	NA
Par 2, Day 113, Bend Down Pick Up Clothing- Floor	0	NA	NA	NA	NA
Par 2, Day 113, Reach-Get Down 5 Lb Obj Above Head	1	NA	NA	NA	NA
Par 2, Day 113, Climb Up Five Steps	0	NA	NA	NA	NA
Par 2, Day 113, Walk Outdoors on Flat Ground	0	NA	NA	NA	NA
Par 3, Day 65, Able to Do Chores	0	NA	NA	NA	NA
Par 3, Day 65, Get In and Out of a car	0	NA	NA	NA	NA
Par 3, Day 65, Run Errands and Shop	0	NA	NA	NA	NA
Par 3, Day 65, Get In and Out of Bed	1	NA	NA	NA	NA
Par 3, Day 65, Stand Up From a Straight Chair	1	NA	NA	NA	NA
Par 3, Day 65, Dress yourself	0	NA	NA	NA	NA
Par 3, Day 65, Shampoo your hair	0	NA	NA	NA	NA
Par 3, Day 65, Cut your meat	0	NA	NA	NA	NA
Par 3, Day 65, Lift a Full Cup or Glass to Mouth	0	NA	NA	NA	NA
Par 3, Day 65, Open a New Milk Carton	0	NA	NA	NA	NA
Par 3, Day 65, Open car doors	0	NA	NA	NA	NA
Par 3, Day 65, Open Jars Previously Opened	0	NA	NA	NA	NA
Par 3, Day 65, Turn Faucets On And Off	0	NA	NA	NA	NA
Par 3, Day 65, Get On and Off The Toilet	0	NA	NA	NA	NA
Par 3, Day 65, Take a Tub Bath	0	NA	NA	NA	NA
Par 3, Day 65, Wash and Dry Your Body	0	NA	NA	NA	NA
Par 3, Day 65, Bend Down Pick Up Clothing- Floor	0	NA	NA	NA	NA
Par 3, Day 65, Reach-Get Down 5 Lb Obj Above Head	1	NA	NA	NA	NA
Par 3, Day 65, Climb Up Five Steps	0	NA	NA	NA	NA
Par 3, Day 65, Walk Outdoors on Flat Ground	0	NA	NA	NA	NA
Par 4, Week 12, Able to Do Chores	NA	0	NA	NA	NA
Par 4, Week 12, Get In and Out of a car	NA	0	NA	NA	NA
Par 4, Week 12, Run Errands and Shop	NA	0	NA	NA	NA
Par 4, Week 12, Get In and Out of Bed	NA	0	NA	NA	NA
Par 4, Week 12, Stand Up From a Straight Chair	NA	0	NA	NA	NA
Par 4, Week 12, Dress yourself	NA	0	NA	NA	NA
Par 4, Week 12, Shampoo your hair	NA	0	NA	NA	NA
Par 4, Week 12, Cut your meat	NA	0	NA	NA	NA
Par 4, Week 12, Lift a Full Cup or Glass to Mouth	NA	0	NA	NA	NA
Par 4, Week 12, Open a New Milk Carton	NA	0	NA	NA	NA
Par 4, Week 12, Open car doors	NA	0	NA	NA	NA
Par 4, Week 12, Open Jars Previously Opened	NA	0	NA	NA	NA
Par 4, Week 12, Turn Faucets On And Off	NA	0	NA	NA	NA
Par 4, Week 12, Get On and Off The Toilet	NA	0	NA	NA	NA
Par 4, Week 12,Take a Tub Bath	NA	0	NA	NA	NA
Par 4, Week 12, Wash and Dry Your Body	NA	0	NA	NA	NA
Par 4, Week 12, Bend Down Pick Up Clothing- Floor	NA	0	NA	NA	NA
Par 4, Week 12, Reach-Get Down 5 Lb Obj Above Head	NA	0	NA	NA	NA
Par 4, Week 12, Climb Up Five Steps	NA	0	NA	NA	NA
Par 4, Week 12, Walk Outdoors on Flat Ground	NA	0	NA	NA	NA
Par 4, Day 373, Able to Do Chores	NA	0	NA	NA	NA
Par 4, Day 373, Get In and Out of a car	NA	0	NA	NA	NA
Par 4, Day 373, Run Errands and Shop	NA	0	NA	NA	NA
Par 4, Day 373, Get In and Out of Bed	NA	0	NA	NA	NA
Par 4, Day 373, Stand Up From a Straight Chair	NA	0	NA	NA	NA
Par 4, Day 373, Dress yourself	NA	0	NA	NA	NA
Par 4, Day 373, Shampoo your hair	NA	0	NA	NA	NA
Par 4, Day 373, Cut your meat	NA	0	NA	NA	NA
Par 4, Day 373, Lift a Full Cup or Glass to Mouth	NA	0	NA	NA	NA
Par 4, Day 373, Open a New Milk Carton	NA	0	NA	NA	NA
Par 4, Day 373, Open car doors	NA	0	NA	NA	NA
Par 4, Day 373, Open Jars Previously Opened	NA	0	NA	NA	NA
Par 4, Day 373, Turn Faucets On And Off	NA	0	NA	NA	NA
Par 4, Day 373, Get On and Off The Toilet	NA	0	NA	NA	NA
Par 4, Day 373,Take a Tub Bath	NA	0	NA	NA	NA
Par 4, Day 373, Wash and Dry Your Body	NA	0	NA	NA	NA
Par 4, Day 373, Bend Down Pick Up Clothing- Floor	NA	0	NA	NA	NA
Par 4, Day 373, Reach-Get Down 5 Lb Obj Above Head	NA	0	NA	NA	NA
Par 4, Day 373, Climb Up Five Steps	NA	0	NA	NA	NA
Par 4, Day 373, Walk Outdoors on Flat Ground	NA	0	NA	NA	NA
Par 5, Day 64, Able to Do Chores	NA	0	NA	NA	NA
Par 5, Day 64, Get In and Out of a car	NA	0	NA	NA	NA
Par 5, Day 64, Run Errands and Shop	NA	0	NA	NA	NA
Par 5, Day 64, Get In and Out of Bed	NA	0	NA	NA	NA
Par 5, Day 64, Stand Up From a Straight Chair	NA	0	NA	NA	NA
Par 5, Day 64, Dress yourself	NA	1	NA	NA	NA
Par 5, Day 64, Shampoo your hair	NA	0	NA	NA	NA
Par 5, Day 64, Cut your meat	NA	0	NA	NA	NA
Par 5, Day 64, Lift a Full Cup or Glass to Mouth	NA	0	NA	NA	NA
Par 5, Day 64, Open a New Milk Carton	NA	0	NA	NA	NA
Par 5, Day 64, Open car doors	NA	0	NA	NA	NA
Par 5, Day 64, Open Jars Previously Opened	NA	0	NA	NA	NA
Par 5, Day 64, Turn Faucets On And Off	NA	0	NA	NA	NA
Par 5, Day 64, Get On and Off The Toilet	NA	0	NA	NA	NA
Par 5, Day 64,Take a Tub Bath	NA	0	NA	NA	NA
Par 5, Day 64, Wash and Dry Your Body	NA	0	NA	NA	NA
Par 5, Day 64, Bend Down Pick Up Clothing- Floor	NA	1	NA	NA	NA
Par 5, Day 64, Reach-Get Down 5 Lb Obj Above Head	NA	1	NA	NA	NA
Par 5, Day 64, Climb Up Five Steps	NA	1	NA	NA	NA
Par 5, Day 64, Walk Outdoors on Flat Ground	NA	1	NA	NA	NA
Par 6, Day 85 Able to Do Chores	NA	NA	1	NA	NA
Par 6, Day 85, Get In and Out of a car	NA	NA	0	NA	NA
Par 6, Day 85, Run Errands and Shop	NA	NA	0	NA	NA
Par 6, Day 85, Get In and Out of Bed	NA	NA	0	NA	NA
Par 6, Day 85, Stand Up From a Straight Chair	NA	NA	0	NA	NA
Par 6, Day 85, Dress yourself	NA	NA	0	NA	NA
Par 6, Day 85,Shampoo your hair	NA	NA	0	NA	NA
Par 6, Day 85, Cut your meat	NA	NA	0	NA	NA
Par 6, Day 85, Lift a Full Cup or Glass to Mouth	NA	NA	0	NA	NA
Par 6, Day 85, Open a New Milk Carton	NA	NA	0	NA	NA
Par 6, Day 85, Open car doors	NA	NA	0	NA	NA
Par 6, Day 85, Open Jars Previously Opened	NA	NA	1	NA	NA
Par 6, Day 85, Turn Faucets On And Off	NA	NA	0	NA	NA
Par 6, Day 85, Get On and Off The Toilet	NA	NA	0	NA	NA
Par 6, Day 85,Take a Tub Bath	NA	NA	1	NA	NA
Par 6, Day 85, Wash and Dry Your Body	NA	NA	0	NA	NA
Par 6, Day 85, Bend Down Pick Up Clothing- Floor	NA	NA	0	NA	NA
Par 6, Day 85, Reach-Get Down 5 Lb Obj Above Head	NA	NA	0	NA	NA
Par 6, Day 85, Climb Up Five Steps	NA	NA	0	NA	NA
Par 6, Day 85, Walk Outdoors on Flat Ground	NA	NA	0	NA	NA
Par 7, Day 169, Able to Do Chores	NA	NA	NA	0	NA
Par 7, Day 169, Get In and Out of a car	NA	NA	NA	0	NA
Par 7, Day 169, Run Errands and Shop	NA	NA	NA	0	NA
Par 7, Day 169, Get In and Out of Bed	NA	NA	NA	0	NA
Par 7, Day 169, Stand Up From a Straight Chair	NA	NA	NA	0	NA
Par 7, Day 169, Dress yourself	NA	NA	NA	0	NA
Par 7, Day 169,Shampoo your hair	NA	NA	NA	0	NA
Par 7, Day 169, Cut your meat	NA	NA	NA	0	NA
Par 7, Day 169, Lift a Full Cup or Glass to Mouth	NA	NA	NA	0	NA
Par 7, Day 169, Open a New Milk Carton	NA	NA	NA	0	NA
Par 7, Day 169, Open car doors	NA	NA	NA	0	NA
Par 7, Day 169, Open Jars Previously Opened	NA	NA	NA	0	NA
Par 7, Day 169, Turn Faucets On And Off	NA	NA	NA	0	NA
Par 7, Day 169, Get On and Off The Toilet	NA	NA	NA	0	NA
Par 7, Day 169,Take a Tub Bath	NA	NA	NA	0	NA
Par 7, Day 169, Wash and Dry Your Body	NA	NA	NA	0	NA
Par 7, Day 169, Bend Down Pick Up Clothing- Floor	NA	NA	NA	0	NA
Par 7, Day 169, Reach-Get Down 5 Lb Obj Above Head	NA	NA	NA	0	NA
Par 7, Day 169, Climb Up Five Steps	NA	NA	NA	0	NA
Par 7, Day 169, Walk Outdoors on Flat Ground	NA	NA	NA	0	NA
Par 8, Week 12, Able to Do Chores	NA	NA	NA	NA	0
Par 8, Week 12, Get In and Out of a car	NA	NA	NA	NA	0
Par 8, Week 12, Run Errands and Shop	NA	NA	NA	NA	0
Par 8, Week 12, Get In and Out of Bed	NA	NA	NA	NA	0
Par 8, Week 12, Stand Up From a Straight Chair	NA	NA	NA	NA	0
Par 8, Week 12, Dress yourself	NA	NA	NA	NA	0
Par 8, Week 12,Shampoo your hair	NA	NA	NA	NA	0
Par 8, Week 12, Cut your meat	NA	NA	NA	NA	0
Par 8, Week 12, Lift a Full Cup or Glass to Mouth	NA	NA	NA	NA	0
Par 8, Week 12, Open a New Milk Carton	NA	NA	NA	NA	0
Par 8, Week 12, Open car doors	NA	NA	NA	NA	0
Par 8, Week 12, Open Jars Previously Opened	NA	NA	NA	NA	0
Par 8, Week 12, Turn Faucets On And Off	NA	NA	NA	NA	0
Par 8, Week 12, Get On and Off The Toilet	NA	NA	NA	NA	0
Par 8, Week 12,Take a Tub Bath	NA	NA	NA	NA	0
Par 8, Week 12, Wash and Dry Your Body	NA	NA	NA	NA	0
Par 8, Week 12, Bend Down Pick Up Clothing- Floor	NA	NA	NA	NA	0
Par 8, Week 12 Reach-Get Down 5 Lb Obj Above Head	NA	NA	NA	NA	0
Par 8, Week 12, Climb Up Five Steps	NA	NA	NA	NA	0
Par 8, Week 12, Walk Outdoors on Flat Ground	NA	NA	NA	NA	0
Par 8, Day 112, Able to Do Chores	NA	NA	NA	NA	0
Par 8, Day 112, Get In and Out of a car	NA	NA	NA	NA	0
Par 8, Day 112, Run Errands and Shop	NA	NA	NA	NA	0
Par 8, Day 112, Get In and Out of Bed	NA	NA	NA	NA	0
Par 8, Day 112, Stand Up From a Straight Chair	NA	NA	NA	NA	0
Par 8, Day 112, Dress yourself	NA	NA	NA	NA	0
Par 8, Day 112, Shampoo your hair	NA	NA	NA	NA	0
Par 8, Day 112, Cut your meat	NA	NA	NA	NA	0
Par 8, Day 112, Lift a Full Cup or Glass to Mout	NA	NA	NA	NA	0
Par 8, Day 112, Open a New Milk Carton	NA	NA	NA	NA	0
Par 8, Day 112, Open car doors	NA	NA	NA	NA	0
Par 8, Day 112, Open Jars Previously Opened	NA	NA	NA	NA	0
Par 8, Day 112, Turn Faucets On And Off	NA	NA	NA	NA	0
Par 8, Day 112, Get On and Off The Toilet	NA	NA	NA	NA	0
Par 8, Day 112, Take a Tub Bath	NA	NA	NA	NA	0
Par 8, Day 112, Wash and Dry Your Body	NA	NA	NA	NA	0
Par 8, Day 112, Bend Down Pick Up Clothing- Floor	NA	NA	NA	NA	0
Par 8, Day 112, Reach-Get Down 5 Lb Obj Above Head	NA	NA	NA	NA	0
Par 8, Day 112, Climb Up Five Steps	NA	NA	NA	NA	0
Par 8, Day 112, Walk Outdoors on Flat Ground	NA	NA	NA	NA	0

81. Secondary Outcome

Title	Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Description	The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	2	1	1	2	2
Par 1, Week 2	4.3	NA	NA	NA	NA
Par 1, Week 4	2.3	NA	NA	NA	NA
Par 1, Week 8	-0.2	NA	NA	NA	NA
Par 1, Week 12	4.0	NA	NA	NA	NA
Par 1, Week 16	4.7	NA	NA	NA	NA
Par 1, Week 24	2.2	NA	NA	NA	NA
Par 1, Week 36	0.4	NA	NA	NA	NA
Par 1, Day 339	-0.7	NA	NA	NA	NA
Par 2, Week 4	-1.0	NA	NA	NA	NA
Par 2, Week 8	-0.3	NA	NA	NA	NA
Par 2, Week 12	-0.6	NA	NA	NA	NA
Par 2, Week 16	-0.7	NA	NA	NA	NA
Par 2, Week 24	0.5	NA	NA	NA	NA
Par 2, Week 36	-0.6	NA	NA	NA	NA
Par 2, Week 38	0.9	NA	NA	NA	NA
Par 2, Week 40	-0.3	NA	NA	NA	NA
Par 2, Day 344	-0.7	NA	NA	NA	NA
Par 3,Par 3,, Day 113	NA	2.1	NA	NA	NA
Par 4, Week 4	NA	NA	-1.0	NA	NA
Par 4, Week 8	NA	NA	4.9	NA	NA
Par 4, Week 12	NA	NA	0.4	NA	NA
Par 5, Week 4	NA	NA	NA	2.0	NA
Par 5, Week 8	NA	NA	NA	NA	0.4
Par 5, Week 12	NA	NA	NA	0.2	NA
Par 5, Week 14	NA	NA	NA	1.0	NA
Par 5, Week 16	NA	NA	NA	1.0	NA
Par 5, Day 162	NA	NA	NA	0.8	NA
Par 6, Week 4	NA	NA	NA	-3.1	NA
Par 6, Week 8	NA	NA	NA	-3.2	NA
Par 6, Day 91	NA	NA	NA	-3.5	NA
Par 7, Week 2	NA	NA	NA	NA	-0.7
Par 7, Week 4	NA	NA	NA	NA	0.7
Par 7, Week 8	NA	NA	NA	NA	0.8
Par 7, Day 85	NA	NA	NA	NA	-0.4
Par 8, Week 2	NA	NA	NA	NA	-0.1
Par 8, Week 4	NA	NA	NA	NA	-3.7
Par 8, Day 87	NA	NA	NA	NA	-3.1
Par 6, Week 2	NA	NA	NA	-0.1	NA

82. Secondary Outcome

Title	Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Description	The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Time Frame	Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	6	4	3	2	2
Par 1, Day 30	0.2	NA	NA	NA	NA
Par 2, Day 29	-0.1	NA	NA	NA	NA
Par 3, Day 23	0.0	NA	NA	NA	NA
Par 4, Week 4	-0.2	NA	NA	NA	NA
Par 4, Week 8	0.1	NA	NA	NA	NA
Par 4, Week 12	0.0	NA	NA	NA	NA
Par 4, Day 113	0.0	NA	NA	NA	NA
Par 5, Week 4	0.1	NA	NA	NA	NA
Par 5, Week 8	0.4	NA	NA	NA	NA
Par 5, Day 85	2.3	NA	NA	NA	NA
Par 6, Week 4	-1.0	NA	NA	NA	NA
Par 6, Day 65	0.5	NA	NA	NA	NA
Par 7, Week 4	NA	1.0	NA	NA	NA
Par 7, Week 8	NA	0.0	NA	NA	NA
Par 7, Week 12	NA	0.0	NA	NA	NA
Par 7, Week 16	NA	0.2	NA	NA	NA
Par 7, Week 36	NA	0.2	NA	NA	NA
Par 7, Day 373	NA	0.9	NA	NA	NA
Par 8, Week 4	NA	-0.2	NA	NA	NA
Par 8, Day 64	NA	-0.4	NA	NA	NA
Par 9, Day 29	NA	0.1	NA	NA	NA
Par 10, Week 4	NA	0.0	NA	NA	NA
Par 10, Day 57	NA	-0.3	NA	NA	NA
Par 11, Week 4	NA	NA	-0.1	NA	NA
Par 11, Week 8	NA	NA	0.2	NA	NA
Par 11, Week 12	NA	NA	0.2	NA	NA
Par 11, Week 16	NA	NA	1.2	NA	NA
Par 11, Day 163	NA	NA	0.3	NA	NA
Par 12, Week 4	NA	NA	-0.8	NA	NA
Par 12, Week 8	NA	NA	-0.7	NA	NA
Par 12, Day 85	NA	NA	0.9	NA	NA
Par 13, Week 4	NA	NA	-0.7	NA	NA
Par 13, Day 59	NA	NA	1.0	NA	NA
Par 14, Week 4	NA	NA	NA	-0.4	NA
Par 14, Day 57	NA	NA	NA	-0.9	NA
Par 15, Day 169	NA	NA	NA	-1.1	NA
Par 16, Week 4	NA	NA	NA	NA	-0.3
Par 16, Week 12	NA	NA	NA	NA	-0.3
Par 16, Day 112	NA	NA	NA	NA	-0.1
Par 17, Week 8	NA	NA	NA	NA	0.2
Par 17, Day 85	NA	NA	NA	NA	-0.1

83. Secondary Outcome

Title	Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Description	In PhGA was based on "What is physician's assessment of the participant's current disease activity". PhGA used a 10 cm VAS ranging from 0 ("none") to 10 ("extremely active"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	2	1	1	2	2
Par 1, Week 2	0.0	NA	NA	NA	NA
Par 1, Week 4	-0.5	NA	NA	NA	NA
Par 1, Week 8	-1.2	NA	NA	NA	NA
Par 1, Week 12	-0.6	NA	NA	NA	NA
Par 1, Week 16	-0.9	NA	NA	NA	NA
Par 1, Week 24	-0.6	NA	NA	NA	NA
Par 1, Week 36	-1.1	NA	NA	NA	NA
Par 1, Day 339	-1.2	NA	NA	NA	NA
Par 2, Week 4	0.0	NA	NA	NA	NA
Par 2, Week 8	0.1	NA	NA	NA	NA
Par 2, Week 12	0.4	NA	NA	NA	NA
Par 2, Week 16	0.1	NA	NA	NA	NA
Par 2, Week 24	0.0	NA	NA	NA	NA
Par 2, Week 36	0.1	NA	NA	NA	NA
Par 2, Week 38	0.7	NA	NA	NA	NA
Par 2, Week 40	0.4	NA	NA	NA	NA
Par 2, Day 344	0.2	NA	NA	NA	NA
Par 3, Day 113	NA	-0.2	NA	NA	NA
Par 4, Week 4	NA	NA	-0.2	NA	NA
Par 4, Week 12	NA	NA	0.1	NA	NA
Par 5, Week 4	NA	NA	NA	1.8	NA
Par 5, Week 8	NA	NA	NA	-1.1	NA
Par 5, Week 12	NA	NA	NA	-0.7	NA
Par 5, Week 14	NA	NA	NA	1.5	NA
Par 5, Week 16	NA	NA	NA	-1.1	NA
Par 5, Day 162	NA	NA	NA	-0.4	NA
Par 6, Day 203	NA	NA	NA	7.6	NA
Par 7, Week 2	NA	NA	NA	NA	0.0
Par 7, Week 4	NA	NA	NA	NA	0.1
Par 7, Week 8	NA	NA	NA	NA	0.0
Par 7, Day 85	NA	NA	NA	NA	0.0
Par 8, Week 2	NA	NA	NA	NA	-6.0
Par 8, Week 4	NA	NA	NA	NA	-6.3

84. Secondary Outcome

Title	Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Description	In PhGA was based on "What is physician's assessment of the participant's current disease activity". PhGA used a 10 cm VAS ranging from 0 ("none") to 10 ("extremely active"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Time Frame	Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373

Outcome Measure Data

Analysis Population Description

ITT-Part B Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	6	4	3	2	2
Par 1, Day 30	0.0	NA	NA	NA	NA
Par 2, Day 29	0.1	NA	NA	NA	NA
Par 3, Day 23	0.0	NA	NA	NA	NA
Par 3, Week 12	0.7	NA	NA	NA	NA
Par 4, Day 113	0.0	NA	NA	NA	NA
Par 5, Week 4	-0.3	NA	NA	NA	NA
Par 5, Day 85	0.3	NA	NA	NA	NA
Par 6, Week 4	-0.2	NA	NA	NA	NA
Par 6, Day 65	-0.3	NA	NA	NA	NA
Par 7, Week 4	NA	0.2	NA	NA	NA
Par 7, Week 8	NA	0.0	NA	NA	NA
Par 7, Week 12	NA	0.2	NA	NA	NA
Par 7, Week 16	NA	0.4	NA	NA	NA
Par 7, Week 36	NA	0.2	NA	NA	NA
Par 7, Day 373	NA	0.0	NA	NA	NA
Par 8, Week 4	NA	0.4	NA	NA	NA
Par 8, Day 64	NA	0.1	NA	NA	NA
Par 9, Day 29	NA	0.2	NA	NA	NA
Par 10, Week 4	NA	0.0	NA	NA	NA
Par 10, Day 57	NA	0.1	NA	NA	NA
Par 11, Week 12	NA	NA	0.9	NA	NA
Par 11, Week 16	NA	NA	0.9	NA	NA
Par 11, Day 163	NA	NA	0.4	NA	NA
Par 12, Week 4	NA	NA	-0.1	NA	NA
Par 12, Week 8	NA	NA	0.1	NA	NA
Par 12, Day 85	NA	NA	-0.1	NA	NA
Par 13, Week 4	NA	NA	-0.6	NA	NA
Par 13, Day 59	NA	NA	-0.3	NA	NA
Par 14, Week 4	NA	NA	NA	-0.3	NA
Par 14, Day 57	NA	NA	NA	0.3	NA
Par 15, Day 169	NA	NA	NA	-0.5	NA
Par 16, Week 4	NA	NA	NA	NA	-0.1
Par 16, Week 12	NA	NA	NA	NA	0.0
Par 16, Day 112	NA	NA	NA	NA	0.4
Par 17, Week 8	NA	NA	NA	NA	0.1
Par 17, Day 85	NA	NA	NA	NA	0.2

85. Secondary Outcome

Title	Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Description	Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
Time Frame	Baseline (Day 1), Days 103 and 271

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	2	1	1	2	2
Par 1, Day 1: Much Better	1 2.4%	NA NaN	NA NaN	NA NaN	NA NaN
Par 2, Day 1: Much Better	1 2.4%	NA NaN	NA NaN	NA NaN	NA NaN
Par 2, Day 271: Worse	1 2.4%	NA NaN	NA NaN	NA NaN	NA NaN
Par 3, Day 1: Much Better	NA NaN	1 2.6%	NA NaN	NA NaN	NA NaN
Par 4, Day 1: Much Better	NA NaN	NA NaN	1 3.8%	NA NaN	NA NaN
Par 5,Day 1: Slightly Better	NA NaN	NA NaN	NA NaN	1 3.7%	NA NaN
Par 5, Day 103: No change	NA NaN	NA NaN	NA NaN	1 3.7%	NA NaN
Par 6, Day 1: Better	NA NaN	NA NaN	NA NaN	1 3.7%	NA NaN
Par 7, Day 1: Much Better	NA NaN	NA NaN	NA NaN	NA NaN	1 3.7%
Par 8, Day 1: Slightly Better	NA NaN	NA NaN	NA NaN	NA NaN	1 3.7%

86. Secondary Outcome

Title	Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Description	Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
Time Frame	Baseline (Day 1)

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	6	4	3	3	2
Par 1, Day 1: No change	1 2.4%	NA NaN	NA NaN	NA NaN	NA NaN
Par 2, Day 1: Much Better	1 2.4%	NA NaN	NA NaN	NA NaN	NA NaN
Par 3, Day 1: Much Better	1 2.4%	NA NaN	NA NaN	NA NaN	NA NaN
Par 4, Day 1: Much Better	1 2.4%	NA NaN	NA NaN	NA NaN	NA NaN
Par 5, Day 1: Better	1 2.4%	NA NaN	NA NaN	NA NaN	NA NaN
Par 6, Day 1: Much Better	1 2.4%	NA NaN	NA NaN	NA NaN	NA NaN
Par 7, Day 1: Much Better	NA NaN	1 2.6%	NA NaN	NA NaN	NA NaN
Par 8, Day 1: Better	NA NaN	1 2.6%	NA NaN	NA NaN	NA NaN
Par 9, Day 1: Much Better	NA NaN	1 2.6%	NA NaN	NA NaN	NA NaN
Par 10, Day 1: Better	NA NaN	1 2.6%	NA NaN	NA NaN	NA NaN
Par 11, Day 1: Much Better	NA NaN	NA NaN	1 3.8%	NA NaN	NA NaN
Par 12, Day 1: Much Better	NA NaN	NA NaN	1 3.8%	NA NaN	NA NaN
Par 13, Day 1: Better	NA NaN	NA NaN	1 3.8%	NA NaN	NA NaN
Par 14, Day 1: Better	NA NaN	NA NaN	NA NaN	1 3.7%	NA NaN
Par 15, Day 1: Much Better	NA NaN	NA NaN	NA NaN	1 3.7%	NA NaN
Par 16, Day 1: Much Better	NA NaN	NA NaN	NA NaN	1 3.7%	NA NaN
Par 17, Day 1: Much Better	NA NaN	NA NaN	NA NaN	NA NaN	1 3.7%
Par 18, Day 1: Much Better	NA NaN	NA NaN	NA NaN	NA NaN	1 3.7%

87. Secondary Outcome

Title	Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Description	Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	2	1	1	2	2
Week 2, n=1,1,0,1,2	0.00 (NA)	-0.20 (NA)	-3.70 (NA)	-4.20 (2.970)
Week 4, n=2,1,1,2,2	0.10 (0.000)	0.10 (NA)	0.10 (NA)	-2.35 (1.909)	-4.20 (2.828)
Week 8, n=2,1,1,2,1	0.10 (0.000)	-0.10 (NA)	0.30 (NA)	0.55 (6.010)	-2.10 (NA)
Week 12, n=2,1,1,1,0	0.10 (0.000)	-0.10 (NA)	0.10 (NA)	3.90 (NA)
Week 14, n=0,0,0,1,0	-30.20 (NA)
Week 16, n=2,0,0,1,0	0.40 (0.424)	-30.70 (NA)
Week 24, n=2,0,0,0,0	1.90 (2.546)
Week 36, n=2,0,0,0,0	0.80 (0.849)
Week 38, n=1,0,0,0,0	-0.10 (NA)
Week 40, n=1,0,0,0,0	0.00 (NA)

88. Secondary Outcome

Title	Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Description	Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	6	4	3	3	2
Week 4, n=3,3,2,1,2	-0.30 (0.361)	-0.23 (0.252)	0.05 (0.071)	6.10 (NA)	-0.55 (1.202)
Week 8, n=2,1,2,0,2	-0.05 (0.778)	0.00 (NA)	0.00 (0.000)	0.95 (0.636)
Week 12, n=1,1,1,1,1	-0.90 (NA)	0.00 (NA)	0.00 (NA)	-0.80 (NA)	0.70 (NA)
Week 16, n=0,1,1,1,0	0.00 (NA)	0.00 (NA)	-0.70 (NA)
Week 24, n=0,1,0,0,0	0.00 (NA)
Week 36, n=0,1,0,0,0	0.00 (NA)

89. Secondary Outcome

Title	Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Description	Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

Outcome Measure Data

Analysis Population Description

Safety-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	2	1	1	2	2
Week 2, n=1,1,0,1,1	-1.0 (NA)	4.0 (NA)	-14.0 (NA)	-7.0 (NA)
Week 4, n=2,1,1,2,2	0.5 (2.12)	4.0 (NA)	4.0 (NA)	-5.0 (16.97)	-29.5 (31.82)
Week 8, n=2,1,0,2,1	3.0 (7.07)	2.0 (NA)	-6.0 (15.56)	-7.0 (NA)
Week 12, n=2,1,1,1,0	0.0 (1.41)	2.0 (NA)	4.0 (NA)	10.0 (NA)
Week 14, n=0,0,0,1,0	-19.0 (NA)
Week 16, n=2,0,0,1,0	-0.5 (2.12)	-18.0 (NA)
Week 24, n=2,0,0,0,0	-1.5 (0.71)
Week 36, n=2,0,0,0,0	6.0 (11.31)
Week 38, n=1,0,0,0,0	-1.0 (NA)
Week 40, n=1,0,0,0,0	1.0 (NA)

90. Secondary Outcome

Title	Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Description	Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

Outcome Measure Data

Analysis Population Description

Safety-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	6	4	3	3	2
Week 4, n=3,3,3,1,2	-1.7 (5.03)	1.3 (1.53)	-1.0 (1.00)	8.0 (NA)	-2.0 (5.66)
Week 8, n=2,1,3,0,2	-1.0 (7.07)	2.0 (NA)	-2.0 (0.00)	0.0 (2.83)
Week 12, n=1,1,1,1,1	-6.0 (NA)	1.0 (NA)	0.0 (NA)	-6.0 (NA)	12.0 (NA)
Week 16, n=0,1,1,1,0	3.0 (NA)	1.0 (NA)	-4.0 (NA)
Week 24, n=0,1,0,0,0	1.0 (NA)
Week 36, n=0,1,0,0,0	1.0 (NA)

91. Secondary Outcome

Title	Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Description	EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	2	1	1	2	2
Par 1, Week 12	-12	NA	NA	NA	NA
Par 1, Week 24	1	NA	NA	NA	NA
Par 1, Day 339	8	NA	NA	NA	NA
Par 2, Week 12	3	NA	NA	NA	NA
Par 2, Week 24	14	NA	NA	NA	NA
Par 2, Day 344	-1	NA	NA	NA	NA
Par 3, Day 113	NA	1	NA	NA	NA
Par 4, Week 12	NA	NA	-4	NA	NA
Par 5, Week 12	NA	NA	NA	9	NA
Par 5, Day 162	NA	NA	NA	-15	NA
Par 6, Day 91	NA	NA	NA	20	NA
Par 7, Day 85	NA	NA	NA	NA	4
Par 8, Day 87	NA	NA	NA	NA	21

92. Secondary Outcome

Title	Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Description	EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 100 (Best imaginable health state) and 0 (Worst imaginable health state). Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time Frame	Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12

Outcome Measure Data

Analysis Population Description

ITT-Part B Population

Arm/Group Title	PartB:SIR 100 mg SC q2w+6 Month Prednisone	PartB:SIR 100 mg SC q2w+3 Month Prednisone	PartB:SIR 50 mg SC q4w+6 Month Prednisone	PartB:Placebo SC q2w + 6 Month Prednisone	PartB:Placebo SC q2w + 12 Month Prednisone
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in part A	Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in part A	Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in part A	Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in part A
Measure Participants	6	4	3	3	2
Par 1, Day 30	2	NA	NA	NA	NA
Par 2, Day 29	0	NA	NA	NA	NA
Par 3, Day 23	1	NA	NA	NA	NA
Par 4, Week 12	-2	NA	NA	NA	NA
Par 4, Day 113	-47	NA	NA	NA	NA
Par 5, Day 85	-1	NA	NA	NA	NA
Par 6, Day 65	20	NA	NA	NA	NA
Par 7, Week 12	NA	4	NA	NA	NA
Par 7, Day 373	NA	8	NA	NA	NA
Par 8, Day 64	NA	-2	NA	NA	NA
Par 9, Day 29	NA	-1	NA	NA	NA
Par 10, Day 57	NA	5	NA	NA	NA
Par 11, Week 12	NA	NA	-10	NA	NA
Par 11, Day 163	NA	NA	-12	NA	NA
Par 12, Day 85	NA	NA	-8	NA	NA
Par 13, Day 59	NA	NA	10	NA	NA
Par 14, Day 57	NA	NA	NA	-42	NA
Par 16, Day 169	NA	NA	NA	62	NA
Par 17, Week 12	NA	NA	NA	NA	9
Par 17, Day 112	NA	NA	NA	NA	7
Par 18, Day 85	NA	NA	NA	NA	-4

Adverse Events

Time Frame	On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Adverse Event Reporting Description	Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
Arm/Group Title	Part A:SIR 100 mg SC q2w+6 Month Prednisone		Part A:SIR 100 mg SC q2w+3 Month Prednisone		Part A: SIR 50 mg SC q4w+6 Month Prednisone		Part A:Placebo SC q2w + 6 Month Prednisone		Part A:Placebo SC q2w + 12 Month Prednisone		Part B:SIR 100 mg SC q2w+6 Month Prednisone+100mg OL SIR		Part B:SIR 100 mg SC q2w+3 Month Prednisone+100mg OL SIR		Part B:SIR 50 mg SC q4w+6 Month Prednisone+100mg OL SIR		Part B:Placebo SC q2w + 6 Month Prednisone+100mg OL SIR		Part B:Placebo SC q2w + 12 Month Prednisone+100mg OL SIR		Part B:SIR 100 mg SC q2w+6 Month Prednisone/ No 100mg OL SIR		Part B:SIR 100 mg SC q2w+3 Month Prednisone/ No 100mg OL SIR		Part B:SIR 50 mg SC q4w+6 Month Prednisone/ No 100mg OL SIR		Part B:Placebo SC q2w + 6 Month Prednisone/ No 100mg OL SIR		Part B:Placebo SC q2w + 12 Month Prednisone/ No 100mg OL SIR
Arm/Group Description	Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen		Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen		Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen		Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen		Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen		Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.		Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.		Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.		Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.		Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.		Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.		Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.		Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.		Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.		Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
All Cause Mortality
	Part A:SIR 100 mg SC q2w+6 Month Prednisone		Part A:SIR 100 mg SC q2w+3 Month Prednisone		Part A: SIR 50 mg SC q4w+6 Month Prednisone		Part A:Placebo SC q2w + 6 Month Prednisone		Part A:Placebo SC q2w + 12 Month Prednisone		Part B:SIR 100 mg SC q2w+6 Month Prednisone+100mg OL SIR		Part B:SIR 100 mg SC q2w+3 Month Prednisone+100mg OL SIR		Part B:SIR 50 mg SC q4w+6 Month Prednisone+100mg OL SIR		Part B:Placebo SC q2w + 6 Month Prednisone+100mg OL SIR		Part B:Placebo SC q2w + 12 Month Prednisone+100mg OL SIR		Part B:SIR 100 mg SC q2w+6 Month Prednisone/ No 100mg OL SIR		Part B:SIR 100 mg SC q2w+3 Month Prednisone/ No 100mg OL SIR		Part B:SIR 50 mg SC q4w+6 Month Prednisone/ No 100mg OL SIR		Part B:Placebo SC q2w + 6 Month Prednisone/ No 100mg OL SIR		Part B:Placebo SC q2w + 12 Month Prednisone/ No 100mg OL SIR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/39 (0%)		0/26 (0%)		0/27 (0%)		0/27 (0%)		0/2 (0%)		0/1 (0%)		0/1 (0%)		0/2 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/2 (0%)
Serious Adverse Events
	Part A:SIR 100 mg SC q2w+6 Month Prednisone		Part A:SIR 100 mg SC q2w+3 Month Prednisone		Part A: SIR 50 mg SC q4w+6 Month Prednisone		Part A:Placebo SC q2w + 6 Month Prednisone		Part A:Placebo SC q2w + 12 Month Prednisone		Part B:SIR 100 mg SC q2w+6 Month Prednisone+100mg OL SIR		Part B:SIR 100 mg SC q2w+3 Month Prednisone+100mg OL SIR		Part B:SIR 50 mg SC q4w+6 Month Prednisone+100mg OL SIR		Part B:Placebo SC q2w + 6 Month Prednisone+100mg OL SIR		Part B:Placebo SC q2w + 12 Month Prednisone+100mg OL SIR		Part B:SIR 100 mg SC q2w+6 Month Prednisone/ No 100mg OL SIR		Part B:SIR 100 mg SC q2w+3 Month Prednisone/ No 100mg OL SIR		Part B:SIR 50 mg SC q4w+6 Month Prednisone/ No 100mg OL SIR		Part B:Placebo SC q2w + 6 Month Prednisone/ No 100mg OL SIR		Part B:Placebo SC q2w + 12 Month Prednisone/ No 100mg OL SIR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/42 (19%)		6/39 (15.4%)		6/26 (23.1%)		5/27 (18.5%)		6/27 (22.2%)		0/2 (0%)		0/1 (0%)		0/1 (0%)		0/2 (0%)		0/2 (0%)		0/6 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/2 (0%)
Blood and lymphatic system disorders
Anaemia	1/42 (2.4%)	1	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Cardiac disorders
Angina pectoris	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Atrial fibrillation	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Ear and labyrinth disorders
Vertigo	0/42 (0%)	0	0/39 (0%)	0	1/26 (3.8%)	1	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Eye disorders
Retinal artery occlusion	0/42 (0%)	0	1/39 (2.6%)	1	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Gastrointestinal disorders
Large intestine polyp	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
General disorders
Asthenia	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Chest discomfort	0/42 (0%)	0	1/39 (2.6%)	1	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Pyrexia	0/42 (0%)	0	1/39 (2.6%)	1	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Hepatobiliary disorders
Hepatitis cholestatic	1/42 (2.4%)	1	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Infections and infestations
Clostridium difficile colitis	0/42 (0%)	0	0/39 (0%)	0	1/26 (3.8%)	1	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Escherichia sepsis	1/42 (2.4%)	1	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Metapneumovirus infection	1/42 (2.4%)	1	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Pneumonia	0/42 (0%)	0	0/39 (0%)	0	1/26 (3.8%)	1	1/27 (3.7%)	1	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Urinary tract infection	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Vestibular neuronitis	0/42 (0%)	0	1/39 (2.6%)	1	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Injury, poisoning and procedural complications
Brain contusion	1/42 (2.4%)	1	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Fall	1/42 (2.4%)	1	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Rib fracture	0/42 (0%)	0	0/39 (0%)	0	1/26 (3.8%)	1	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Spinal compression fracture	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Subdural haematoma	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Metabolism and nutrition disorders
Electrolyte imbalance	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	1/27 (3.7%)	1	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Spinal osteoarthritis	0/42 (0%)	0	0/39 (0%)	0	1/26 (3.8%)	1	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Synovial cyst	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	1/27 (3.7%)	2	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Tenosynovitis	0/42 (0%)	0	1/39 (2.6%)	1	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Squamous cell carcinoma	0/42 (0%)	0	1/39 (2.6%)	1	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Nervous system disorders
Headache	0/42 (0%)	0	1/39 (2.6%)	1	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Syncope	0/42 (0%)	0	0/39 (0%)	0	2/26 (7.7%)	2	1/27 (3.7%)	1	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Transient ischaemic attack	0/42 (0%)	0	1/39 (2.6%)	1	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Psychiatric disorders
Alcohol withdrawal syndrome	1/42 (2.4%)	1	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Renal and urinary disorders
Nephrolithiasis	0/42 (0%)	0	0/39 (0%)	0	1/26 (3.8%)	1	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Respiratory, thoracic and mediastinal disorders
Bronchiectasis	0/42 (0%)	0	0/36 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis	0/42 (0%)	0	0/39 (0%)	0	1/26 (3.8%)	1	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Skin ulcer	1/42 (2.4%)	1	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Vascular disorders
Temporal arteritis	1/42 (2.4%)	1	0/39 (0%)	0	0/26 (0%)	0	1/27 (3.7%)	1	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Other (Not Including Serious) Adverse Events
	Part A:SIR 100 mg SC q2w+6 Month Prednisone		Part A:SIR 100 mg SC q2w+3 Month Prednisone		Part A: SIR 50 mg SC q4w+6 Month Prednisone		Part A:Placebo SC q2w + 6 Month Prednisone		Part A:Placebo SC q2w + 12 Month Prednisone		Part B:SIR 100 mg SC q2w+6 Month Prednisone+100mg OL SIR		Part B:SIR 100 mg SC q2w+3 Month Prednisone+100mg OL SIR		Part B:SIR 50 mg SC q4w+6 Month Prednisone+100mg OL SIR		Part B:Placebo SC q2w + 6 Month Prednisone+100mg OL SIR		Part B:Placebo SC q2w + 12 Month Prednisone+100mg OL SIR		Part B:SIR 100 mg SC q2w+6 Month Prednisone/ No 100mg OL SIR		Part B:SIR 100 mg SC q2w+3 Month Prednisone/ No 100mg OL SIR		Part B:SIR 50 mg SC q4w+6 Month Prednisone/ No 100mg OL SIR		Part B:Placebo SC q2w + 6 Month Prednisone/ No 100mg OL SIR		Part B:Placebo SC q2w + 12 Month Prednisone/ No 100mg OL SIR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/42 (97.6%)		36/39 (92.3%)		25/26 (96.2%)		26/27 (96.3%)		24/27 (88.9%)		2/2 (100%)		1/1 (100%)		1/1 (100%)		2/2 (100%)		2/2 (100%)		4/6 (66.7%)		3/4 (75%)		2/3 (66.7%)		1/3 (33.3%)		0/2 (0%)
Blood and lymphatic system disorders
Thrombocytopenia	1/42 (2.4%)	1	4/39 (10.3%)	5	1/26 (3.8%)	1	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Ear and labyrinth disorders
Tinnitus	1/42 (2.4%)	1	1/39 (2.6%)	1	2/26 (7.7%)	3	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Endocrine disorders
Cushingoid	1/42 (2.4%)	1	2/39 (5.1%)	2	0/26 (0%)	0	1/27 (3.7%)	1	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Eye disorders
Blepharitis	0/42 (0%)	0	2/39 (5.1%)	2	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Cataract	0/42 (0%)	0	1/39 (2.6%)	1	1/26 (3.8%)	1	1/27 (3.7%)	1	2/27 (7.4%)	3	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Eye pain	1/42 (2.4%)	1	0/39 (0%)	0	1/26 (3.8%)	1	0/27 (0%)	0	2/27 (7.4%)	2	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Chalazion	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	1	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	0/42 (0%)	0	2/39 (5.1%)	2	3/26 (11.5%)	3	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Abdominal pain upper	2/42 (4.8%)	2	2/39 (5.1%)	4	2/26 (7.7%)	3	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Diarrhoea	5/42 (11.9%)	5	2/39 (5.1%)	2	5/26 (19.2%)	12	2/27 (7.4%)	3	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Faeces discoloured	0/42 (0%)	0	2/39 (5.1%)	2	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Gastritis	0/42 (0%)	0	0/39 (0%)	0	1/26 (3.8%)	1	2/27 (7.4%)	2	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Gastrooesophageal reflux disease	0/42 (0%)	0	1/39 (2.6%)	1	2/26 (7.7%)	2	2/27 (7.4%)	2	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/2 (50%)	3	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Haemorrhoids	0/42 (0%)	0	2/39 (5.1%)	3	0/26 (0%)	0	1/27 (3.7%)	1	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Nausea	3/42 (7.1%)	4	2/39 (5.1%)	2	2/26 (7.7%)	2	0/27 (0%)	0	2/27 (7.4%)	2	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/2 (0%)	0
Toothache	4/42 (9.5%)	4	1/39 (2.6%)	1	1/26 (3.8%)	1	2/27 (7.4%)	2	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Abdominal hernia	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Eructation	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	2	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Noninfective gingivitis	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Rectal haemorrhage	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	1/4 (25%)	1	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Dyspepsia	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Abdominal distension	0/42 (0%)	0	0/39 (0%)	0	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
General disorders
Asthenia	3/42 (7.1%)	3	1/39 (2.6%)	2	1/26 (3.8%)	1	1/27 (3.7%)	1	2/27 (7.4%)	2	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Fatigue	2/42 (4.8%)	2	3/39 (7.7%)	41	4/26 (15.4%)	5	2/27 (7.4%)	2	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/2 (0%)	0
Injection site erythema	9/42 (21.4%)	29	4/39 (10.3%)	4	2/26 (7.7%)	5	0/27 (0%)	0	0/27 (0%)	0	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Injection site pain	2/42 (4.8%)	2	3/39 (7.7%)	3	2/26 (7.7%)	6	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Injection site pruritus	3/42 (7.1%)	19	4/39 (10.3%)	7	1/26 (3.8%)	2	0/27 (0%)	0	0/27 (0%)	0	1/2 (50%)	3	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Injection site reaction	6/42 (14.3%)	9	2/39 (5.1%)	6	4/26 (15.4%)	13	0/27 (0%)	0	0/27 (0%)	0	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Injection site swelling	4/42 (9.5%)	6	4/39 (10.3%)	4	2/26 (7.7%)	8	0/27 (0%)	0	0/27 (0%)	0	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Injection site warmth	1/42 (2.4%)	3	2/39 (5.1%)	2	1/26 (3.8%)	1	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Oedema peripheral	5/42 (11.9%)	5	8/39 (20.5%)	14	3/26 (11.5%)	4	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Pain	1/42 (2.4%)	1	1/39 (2.6%)	11	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Infections and infestations
Bronchitis	1/42 (2.4%)	1	3/39 (7.7%)	3	0/26 (0%)	0	2/27 (7.4%)	2	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Gastroenteritis	1/42 (2.4%)	1	2/39 (5.1%)	2	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	1	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	0/2 (0%)	0
Nasopharyngitis	3/42 (7.1%)	3	2/39 (5.1%)	2	3/26 (11.5%)	4	1/27 (3.7%)	1	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/4 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/2 (0%)	0
Onychomycosis	0/42 (0%)	0	2/39 (5.1%)	3	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Oral herpes	0/42 (0%)	0	2/39 (5.1%)	2	1/26 (3.8%)	1	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Rhinitis	1/42 (2.4%)	1	0/39 (0%)	0	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Sinusitis	3/42 (7.1%)	3	3/39 (7.7%)	3	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Upper respiratory tract infection	2/42 (4.8%)	2	8/39 (20.5%)	8	2/26 (7.7%)	2	4/27 (14.8%)	5	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Urinary tract infection	3/42 (7.1%)	4	2/39 (5.1%)	2	2/26 (7.7%)	2	2/27 (7.4%)	2	4/27 (14.8%)	10	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	1	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Viral upper respiratory tract infection	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	1	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Injury, poisoning and procedural complications
Arthropod bite	1/42 (2.4%)	1	1/39 (2.6%)	1	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Contusion	3/42 (7.1%)	4	1/39 (2.6%)	1	2/26 (7.7%)	2	2/27 (7.4%)	2	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Fall	4/42 (9.5%)	8	2/39 (5.1%)	2	0/26 (0%)	0	0/27 (0%)	0	3/27 (11.1%)	3	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Joint dislocation	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	2/27 (7.4%)	3	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Ligament sprain	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	2/27 (7.4%)	2	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Limb injury	4/42 (9.5%)	5	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Road traffic accident	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	2/27 (7.4%)	2	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Tendon rupture	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	2/27 (7.4%)	2	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Foot fracture	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0	0/0 (NaN)	0	0/0 (NaN)	0	0/0 (NaN)	0
Laceration	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Limb traumatic amputation	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	1	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Procedural pain	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	1	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Investigations
C-reactive protein abnormal	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	2/27 (7.4%)	3	0/27 (0%)	0	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Low density lipoprotein increased	1/42 (2.4%)	1	0/39 (0%)	0	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Platelet count decreased	1/42 (2.4%)	1	0/39 (0%)	0	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Alanine aminotransferase increased	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	1	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Aspartate aminotransferase increased	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	1	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Metabolism and nutrition disorders
Hypercholesterolaemia	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	1	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Gout	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Vitamin D deficiency	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	1/4 (25%)	1	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	5/42 (11.9%)	7	4/39 (10.3%)	36	5/26 (19.2%)	6	1/27 (3.7%)	1	4/27 (14.8%)	6	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/2 (0%)	0
Back pain	7/42 (16.7%)	7	3/39 (7.7%)	9	3/26 (11.5%)	5	2/27 (7.4%)	2	4/27 (14.8%)	5	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Bursitis	1/42 (2.4%)	1	2/39 (5.1%)	2	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Muscle spasms	3/42 (7.1%)	6	5/39 (12.8%)	6	3/26 (11.5%)	3	1/27 (3.7%)	2	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Muscular weakness	1/42 (2.4%)	1	3/39 (7.7%)	4	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Musculoskeletal chest pain	2/42 (4.8%)	2	2/39 (5.1%)	3	2/26 (7.7%)	2	1/27 (3.7%)	1	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Musculoskeletal pain	3/42 (7.1%)	3	2/39 (5.1%)	7	1/26 (3.8%)	2	2/27 (7.4%)	2	4/27 (14.8%)	5	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Myalgia	0/42 (0%)	0	1/39 (2.6%)	1	2/26 (7.7%)	2	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Neck pain	1/42 (2.4%)	2	2/39 (5.1%)	5	1/26 (3.8%)	1	0/27 (0%)	0	0/27 (0%)	0	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Osteoarthritis	2/42 (4.8%)	2	1/39 (2.6%)	1	0/26 (0%)	0	0/27 (0%)	0	2/27 (7.4%)	3	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Pain in extremity	3/42 (7.1%)	3	2/39 (5.1%)	6	3/26 (11.5%)	5	2/27 (7.4%)	2	3/27 (11.1%)	3	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Pain in jaw	3/42 (7.1%)	3	2/39 (5.1%)	3	0/26 (0%)	0	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Polymyalgia rheumatica	1/42 (2.4%)	1	1/39 (2.6%)	1	0/26 (0%)	0	1/27 (3.7%)	1	2/27 (7.4%)	2	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Synovial cyst	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Intervertebral disc protrusion	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/2 (0%)	0
Nervous system disorders
Dizziness	3/42 (7.1%)	3	4/39 (10.3%)	5	2/26 (7.7%)	3	1/27 (3.7%)	1	3/27 (11.1%)	3	1/2 (50%)	1	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Headache	13/42 (31%)	20	7/39 (17.9%)	14	8/26 (30.8%)	16	7/27 (25.9%)	7	8/27 (29.6%)	13	0/2 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	1/2 (50%)	1	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/2 (0%)	0
Hypoaesthesia	1/42 (2.4%)	1	2/39 (5.1%)	3	0/26 (0%)	0	1/27 (3.7%)	4	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Paraesthesia	1/42 (2.4%)	1	2/39 (5.1%)	2	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Tremor	3/42 (7.1%)	3	3/39 (7.7%)	3	1/26 (3.8%)	1	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Syncope	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Psychiatric disorders
Insomnia	3/42 (7.1%)	3	2/39 (5.1%)	4	2/26 (7.7%)	2	1/27 (3.7%)	1	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Nervousness	0/42 (0%)	0	0/39 (0%)	0	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	8/42 (19%)	8	2/39 (5.1%)	3	2/26 (7.7%)	2	2/27 (7.4%)	3	3/27 (11.1%)	5	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	1	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Dyspnoea	2/42 (4.8%)	2	2/39 (5.1%)	8	1/26 (3.8%)	1	0/27 (0%)	0	2/27 (7.4%)	2	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Epistaxis	3/42 (7.1%)	4	2/39 (5.1%)	2	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Oropharyngeal pain	4/42 (9.5%)	4	1/39 (2.6%)	1	4/26 (15.4%)	4	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Rhinorrhoea	0/42 (0%)	0	0/39 (0%)	0	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	3/42 (7.1%)	3	2/39 (5.1%)	2	2/26 (7.7%)	2	0/27 (0%)	0	1/27 (3.7%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Hyperhidrosis	5/42 (11.9%)	5	1/39 (2.6%)	5	1/26 (3.8%)	1	1/27 (3.7%)	1	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Night sweats	2/42 (4.8%)	2	1/39 (2.6%)	1	2/26 (7.7%)	2	1/27 (3.7%)	1	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Pruritus	1/42 (2.4%)	1	0/39 (0%)	0	2/26 (7.7%)	2	1/27 (3.7%)	1	1/2 (50%)	1	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/2 (50%)	1	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Swelling face	1/42 (2.4%)	1	1/39 (2.6%)	1	2/26 (7.7%)	2	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Macule	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	1/2 (50%)	1	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Rash	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	0/27 (0%)	0	0/2 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/2 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Purpura	0/42 (0%)	0	0/39 (0%)	0	0/26 (0%)	0	0/27 (0%)	0	2/27 (7.4%)	2	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Vascular disorders
Hypertension	4/42 (9.5%)	5	2/39 (5.1%)	3	4/26 (15.4%)	4	0/27 (0%)	0	1/27 (3.7%)	2	0/2 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/2 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	1/4 (25%)	1	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.