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A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01706926
Collaborator
MedImmune Ltd (Industry)
420
Enrollment
43
Locations
4
Arms
17
Duration (Months)
9.8
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with moderate-to-severe adult onset Rheumatoid Arthritis (RA).

Condition or Disease Intervention/Treatment Phase
  • Biological: Mavrilimumab 30 mg
  • Biological: Mavrilimumab 100 mg
  • Biological: Mavrilimumab 150 mg
  • Other: Placebo
 Phase 2

Detailed Description

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis, there is still significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. The aim of the study is to explore the optimum dose of mavrilimumab for further clinical development and more fully investigate the efficacy and safety profile of mavrilimumab after longer drug exposure (that is, 24 weeks). The results of this study will form the basis for future clinical studies with mavrilimumab.

Study Design

Study Type:
Interventional
Actual Enrollment :
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.

Other: Placebo
Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.
Experimental: Mavrilimumab 30 mg

Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Biological: Mavrilimumab 30 mg
Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks
Other Names:
  • CAM-3001

    		•
    Experimental: Mavrilimumab 100 mg

    Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

    Biological: Mavrilimumab 100 mg
    Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.
    Other Names:
  • CAM-3001

    		•
    Experimental: Mavrilimumab 150 mg

    Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

    Biological: Mavrilimumab 150 mg
    Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.
    Other Names:
  • CAM-3001

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85 [Baseline and Day 85]

      DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.

    2. Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 [Day 169]

      ACR20 was defined as >=20 percent (%) improvement, in: SJC and TJC and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.

    Secondary Outcome Measures

    1. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [Baseline up to Day 169]

      An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.

    2. Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) [Baseline up to Day 169]

      Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and urinalysis.

    3. Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) [Baseline up to Day 169]

      Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.

    4. Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169 [Day 169]

      Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), and forced vital capacity (FVC). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=<) 15 percent (%), more than (>) 15 to =<20%, and >20%.

    5. Dyspnea Score at Day 169 [Day 169]

      Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.

    6. Oxygen Saturation Level at Day 169 [Day 169]

      Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.

    7. Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169 [Day 169]

      ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

    8. Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169 [Day 169]

      ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

    9. Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169 [Baseline up to Day 169]

      ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.

    10. Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169 [Day 169]

      DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.

    11. Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169 [Day 169]

      DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.

    12. Mean Change From Baseline in Swollen and Tender Joint Count at Day 169 [Baseline and Day 169]

      Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.

    13. Mean Change From Baseline in Patient Assessment of Pain at Day 169 [Baseline and Day 169]

      Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

    14. Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169 [Baseline and Day 169]

      Participants responded to a question, "Considering all the ways your arthritis affects you, how are you feeling today?" by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly.

    15. Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169 [Baseline and Day 169]

      Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 centimeter (cm) VAS, where 0 cm = very good and 10 cm = very bad.

    16. Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169 [Baseline and Day 169]

      HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.

    17. Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169 [Baseline, Day 169]

      CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.

    18. Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169 [Baseline, Day 169]

      ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.

    19. Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169 [Day 169]

      The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3.

    20. Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169 [Day 169]

      The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.

    21. Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169 [Day 169]

      ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.

    22. Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169 [Baseline and Day 169]

      FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.

    23. Serum Concentrations of Mavrilimumab [Baseline, Day 8, 15, 29, 85, 141, and 169]

      Serum concentrations after multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.

    24. Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit [Day 1 to Day 169]

      Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • A diagnosis of adult onset Rheumatoid Arthritis (RA) in line with the protocol

    • Moderately active disease in line with the protocol

    • A pre-defined number of swollen joints in line with the protocol

    • Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)

    • No evidence of respiratory disease.

    Exclusion Criteria:

    • A rheumatic autoimmune disease other than RA, or significant systemic extra-articular involvement secondary to RA

    • A history of, or current, inflammatory joint disease other than RA

    • Previous treatment with the investigational drug

    • Discontinuation of a biologic DMARD due to lack of efficacy

    • Non-compliant concurrent medications

    • Non-compliance with medical history criteria.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Ciudad Autonoma de Buenos Aire Argentina
    2 Research Site Rosario Argentina
    3 Research Site San Miguel de Tucuman Argentina
    4 Research Site Plovdiv Bulgaria
    5 Research Site Sofia Bulgaria
    6 Research Site Santiago Chile
    7 Research Site Vina del Mar Chile
    8 Research Site Barranquilla Colombia
    9 Research Site Bogota Colombia
    10 Research Site Bruntal Czech Republic
    11 Research Site Jihlava Czech Republic
    12 Research Site Ostrava - Trebovice Czech Republic
    13 Research Site Praha 2 Czech Republic
    14 Research Site Praha 4 Czech Republic
    15 Research Site Zlin Czech Republic
    16 Research Site Tallinn Estonia
    17 Research Site Hildesheim Germany
    18 Research Site Köln Germany
    19 Research Site Magdeburg Germany
    20 Research Site Budapest Hungary
    21 Research Site Debrecen Hungary
    22 Research Site Gdynia Poland
    23 Research Site Grodzisk Mazowiecki Poland
    24 Research Site Katowice Poland
    25 Research Site Krakow Poland
    26 Research Site Warszawa Poland
    27 Research Site Wroclaw Poland
    28 Research Site Barnaul Russian Federation
    29 Research Site Kazan Russian Federation
    30 Research Site Moscow Russian Federation
    31 Research Site Novosibirsk Russian Federation
    32 Research Site St. Petersburg Russian Federation
    33 Research Site Yaroslavl Russian Federation
    34 Research Site Belgrade Serbia
    35 Research Site Niska Banja Serbia
    36 Research Site Durban South Africa
    37 Research Site Barcelona Spain
    38 Research Site Santiago de Compostela Spain
    39 Research Site Donetsk Ukraine
    40 Research Site Kharkiv Ukraine
    41 Research Site Kiev Ukraine
    42 Research Site Lutsk Ukraine
    43 Research Site Vinnytsia Ukraine

    Sponsors and Collaborators

    • MedImmune LLC
    • MedImmune Ltd

    Investigators

    • Study Director: Marius Albulescu, MD, MedImmune Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MedImmune LLC
    ClinicalTrials.gov Identifier:
    NCT01706926
    Other Study ID Numbers:
    • CD-IA-CAM-3001-1071
    First Posted:
    Oct 15, 2012
    Last Update Posted:
    Sep 27, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by MedImmune LLC
    Rheumatoid Arthritis
    Mavrilimumab
    CAM-3001
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Mavrilimumab
    Antibodies, Monoclonal

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 420 participants were screened out of which 326 participants were randomized and received investigational product in the study.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Period Title: Overall Study
    STARTED 81 81 85 79
    COMPLETED 75 77 79 74
    NOT COMPLETED 6 4 6 5

    Baseline Characteristics

    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg Total
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Total of all reporting groups
    Overall Participants 81 81 85 79 326
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52.8
    (10.6)
    51.2
    (11.6)
    50.8
    (11.9)
    52.6
    (10.3)
    51.8
    (11.1)
    Sex: Female, Male (Count of Participants)
    Female
    75
    92.6%
    70
    86.4%
    70
    82.4%
    67
    84.8%
    282
    86.5%
    Male
    6
    7.4%
    11
    13.6%
    15
    17.6%
    12
    15.2%
    44
    13.5%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85
    Description DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.
    Time Frame Baseline and Day 85

    Outcome Measure Data

    Analysis Population Description
    The modified intent-to-treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Baseline (n=81, 81, 85, 79)
    5.78
    (0.090)
    5.73
    (0.104)
    5.91
    (0.096)
    5.67
    (0.086)
    Change at Day 85 (n=77, 76, 79, 78)
    -0.68
    (0.136)
    -1.37
    (0.136)
    -1.64
    (0.132)
    -1.90
    (0.136)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95 percent (%) confidence interval (CI) was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -0.69
    Confidence Interval (2-Sided) 95%
    -1.06 to -0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.193
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -0.96
    Confidence Interval (2-Sided) 95%
    -1.33 to -0.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.190
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -1.22
    Confidence Interval (2-Sided) 95%
    -1.60 to -0.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.193
    Estimation Comments
    2. Primary Outcome
    Title Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169
    Description ACR20 was defined as >=20 percent (%) improvement, in: SJC and TJC and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Number [percentage of participants]
    24.7
    30.5%
    50.6
    62.5%
    61.2
    72%
    73.4
    92.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 25.9
    Confidence Interval (2-Sided) 95%
    11.5 to 40.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 36.5
    Confidence Interval (2-Sided) 95%
    22.5 to 50.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 48.7
    Confidence Interval (2-Sided) 95%
    35.2 to 62.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    3. Secondary Outcome
    Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
    Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.
    Time Frame Baseline up to Day 169

    Outcome Measure Data

    Analysis Population Description
    The safety population included all participants who received any dose of investigational product.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    TEAEs
    46.9
    57.9%
    50.6
    62.5%
    42.4
    49.9%
    54.4
    68.9%
    TESAEs
    1.2
    1.5%
    4.9
    6%
    5.9
    6.9%
    2.5
    3.2%
    4. Secondary Outcome
    Title Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
    Description Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and urinalysis.
    Time Frame Baseline up to Day 169

    Outcome Measure Data

    Analysis Population Description
    The safety population included all participants who received any dose of investigational product.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Anemia
    1
    1.2%
    1
    1.2%
    0
    0%
    0
    0%
    Eosinophilia
    0
    0%
    0
    0%
    1
    1.2%
    0
    0%
    Leukocytosis
    2
    2.5%
    0
    0%
    0
    0%
    0
    0%
    Lymphopenia
    0
    0%
    0
    0%
    0
    0%
    1
    1.3%
    Neutropenia
    1
    1.2%
    0
    0%
    0
    0%
    3
    3.8%
    Alanine aminotransferase increased
    0
    0%
    1
    1.2%
    1
    1.2%
    1
    1.3%
    Aspartate aminotransferase increased
    0
    0%
    1
    1.2%
    1
    1.2%
    0
    0%
    Gamma-glutamyltransferase increased
    0
    0%
    1
    1.2%
    0
    0%
    0
    0%
    Hypertransaminasaemia
    0
    0%
    0
    0%
    2
    2.4%
    2
    2.5%
    Dislipidaemia
    0
    0%
    0
    0%
    1
    1.2%
    0
    0%
    Hypercholesterolaemia
    1
    1.2%
    0
    0%
    1
    1.2%
    0
    0%
    Hyperlipidaemia
    0
    0%
    2
    2.5%
    0
    0%
    3
    3.8%
    Hyperkalaemia
    0
    0%
    0
    0%
    0
    0%
    1
    1.3%
    5. Secondary Outcome
    Title Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
    Description Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.
    Time Frame Baseline up to Day 169

    Outcome Measure Data

    Analysis Population Description
    The safety population included all participants who received any dose of investigational product.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Hypertension
    2
    2.5%
    4
    4.9%
    4
    4.7%
    3
    3.8%
    Weight increased
    1
    1.2%
    1
    1.2%
    1
    1.2%
    0
    0%
    Pyrexia
    0
    0%
    1
    1.2%
    0
    0%
    0
    0%
    Hot flush
    0
    0%
    0
    0%
    1
    1.2%
    0
    0%
    6. Secondary Outcome
    Title Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169
    Description Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), and forced vital capacity (FVC). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=<) 15 percent (%), more than (>) 15 to =<20%, and >20%.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    The safety population included all participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    FEV1 =<15% (n=42,67,75,75)
    97.6
    98.5
    96.0
    89.3
    FEV1 >15 to 20% (n=42,67,75,75)
    0.0
    0.0
    1.3
    6.7
    FEV1 >20% (n=42,67,75,75)
    2.4
    1.5
    2.7
    4.0
    FEV6 =<15% (n=41,66,71,68)
    97.6
    97.0
    94.4
    89.7
    FEV6 >15 to 20% (n=41,66,71,68)
    0.0
    1.5
    1.4
    1.5
    FEV6 >20% (n=41,66,71,68)
    2.4
    1.5
    4.2
    8.8
    FVC =<15% (n=42,67,75,75)
    97.6
    98.5
    94.7
    94.7
    FVC >15 to 20% (n=42,67,75,75)
    0.0
    0.0
    1.3
    2.7
    FVC >20% (n=42,67,75,75)
    2.4
    1.5
    4.0
    2.7
    7. Secondary Outcome
    Title Dyspnea Score at Day 169
    Description Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    The safety population included all participants who received any dose of investigational product. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 41 65 73 74
    Mean (Standard Deviation) [units on a scale]
    0.38
    (0.62)
    0.22
    (0.54)
    0.32
    (0.73)
    0.28
    (0.64)
    8. Secondary Outcome
    Title Oxygen Saturation Level at Day 169
    Description Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    The safety population included all participants who received any dose of investigational product. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 40 65 73 74
    Mean (Standard Deviation) [percent saturation]
    97.4
    (1.4)
    97.4
    (1.1)
    97.4
    (1.1)
    97.3
    (1.2)
    9. Secondary Outcome
    Title Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169
    Description ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Number [percentage of participants]
    12.3
    15.2%
    28.4
    35.1%
    25.9
    30.5%
    40.5
    51.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 16.0
    Confidence Interval (2-Sided) 95%
    3.9 to 28.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.030
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 13.5
    Confidence Interval (2-Sided) 95%
    1.8 to 25.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 28.2
    Confidence Interval (2-Sided) 95%
    15.2 to 41.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    10. Secondary Outcome
    Title Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169
    Description ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Number [percentage of participants]
    3.7
    4.6%
    12.3
    15.2%
    10.6
    12.5%
    13.9
    17.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.079
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 8.6
    Confidence Interval (2-Sided) 95%
    0.4 to 16.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.133
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 6.9
    Confidence Interval (2-Sided) 95%
    -0.8 to 14.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.026
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 10.2
    Confidence Interval (2-Sided) 95%
    1.5 to 18.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.
    11. Secondary Outcome
    Title Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169
    Description ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.
    Time Frame Baseline up to Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 38 63 72 74
    Mean (Standard Error) [units on a scale]
    13.25
    (4.630)
    29.04
    (3.828)
    30.24
    (3.623)
    40.72
    (3.644)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted Mean difference
    Estimated Value 15.79
    Confidence Interval (2-Sided) 95%
    3.96 to 27.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.007
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value 16.99
    Confidence Interval (2-Sided) 95%
    5.42 to 28.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.879
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value 27.47
    Confidence Interval (2-Sided) 95%
    15.87 to 39.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.892
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.
    12. Secondary Outcome
    Title Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169
    Description DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    No response
    65.4
    (0.090) 80.7%
    30.9
    (0.104) 38.1%
    28.2
    (0.096) 33.2%
    19.0
    (0.086) 24.1%
    Moderate response
    25.9
    (0.136) 32%
    35.8
    (0.136) 44.2%
    40.0
    (0.132) 47.1%
    41.8
    (0.136) 52.9%
    Good response
    8.6
    10.6%
    33.3
    41.1%
    31.8
    37.4%
    39.2
    49.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Proportional odds analysis
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.70
    Confidence Interval (2-Sided) 95%
    2.56 to 8.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios greater than (>) one favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Proportional odds analysis
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.81
    Confidence Interval (2-Sided) 95%
    2.64 to 8.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios >one favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Proportional odds analysis
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.11
    Confidence Interval (2-Sided) 95%
    3.85 to 13.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios >one favored mavrilimumab.
    13. Secondary Outcome
    Title Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169
    Description DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    DAS28 (CRP) Remission
    4.9
    6%
    21.0
    25.9%
    17.6
    20.7%
    19.0
    24.1%
    Low Disease Activity
    8.6
    10.6%
    33.3
    41.1%
    31.8
    37.4%
    41.8
    52.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 16.0
    Confidence Interval (2-Sided) 95%
    6.0 to 26.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.014
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 12.7
    Confidence Interval (2-Sided) 95%
    3.3 to 22.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 14.0
    Confidence Interval (2-Sided) 95%
    4.2 to 23.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments The analysis reported DAS28 (CRP) low disease activity response.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 24.7
    Confidence Interval (2-Sided) 95%
    12.7 to 36.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments The analysis reported DAS28 (CRP) low disease activity response.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 23.1
    Confidence Interval (2-Sided) 95%
    11.5 to 34.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments The analysis reported DAS28 (CRP) low disease activity response.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 33.1
    Confidence Interval (2-Sided) 95%
    20.7 to 45.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.
    14. Secondary Outcome
    Title Mean Change From Baseline in Swollen and Tender Joint Count at Day 169
    Description Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.
    Time Frame Baseline and Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    SJC: Baseline (n=81,81,85,79)
    14.44
    (0.765)
    17.80
    (1.126)
    16.82
    (0.930)
    15.72
    (0.795)
    SJC: Change at Day 169 (n=40,65,73,74)
    -4.97
    (0.932)
    -10.65
    (0.809)
    -11.18
    (0.771)
    -11.96
    (0.787)
    TJC: Baseline (n=81,81,85,79)
    26.26
    (1.250)
    27.48
    (1.553)
    26.96
    (1.544)
    26.70
    (1.284)
    TJC: Change at Day 169 (n=40,65,73,74)
    -7.90
    (1.447)
    -15.14
    (1.265)
    -16.35
    (1.207)
    -18.32
    (1.234)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments Analysis reported for change from baseline in swollen joint count at Day 169.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -5.68
    Confidence Interval (2-Sided) 95%
    -8.12 to -3.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.237
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments Analysis reported for change from baseline in swollen joint count at Day 169.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -6.21
    Confidence Interval (2-Sided) 95%
    -8.60 to -3.82
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.211
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments Analysis reported for change from baseline in swollen joint count at Day 169.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -7.00
    Confidence Interval (2-Sided) 95%
    -9.40 to -4.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.219
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments Analysis reported for change from baseline in tender joint count at Day 169.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -7.24
    Confidence Interval (2-Sided) 95%
    -11.02 to -3.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.922
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments Analysis reported for change from baseline in tender joint count at Day 169.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -8.45
    Confidence Interval (2-Sided) 95%
    -12.16 to -4.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.884
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments Analysis reported for change from baseline in tender joint count at Day 169.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -10.42
    Confidence Interval (2-Sided) 95%
    -14.17 to -6.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.901
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    15. Secondary Outcome
    Title Mean Change From Baseline in Patient Assessment of Pain at Day 169
    Description Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
    Time Frame Baseline and Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Baseline (n=81, 81, 85, 79)
    62.16
    (2.093)
    62.65
    (2.110)
    63.58
    (2.034)
    62.35
    (2.217)
    Change at Day 169 (n=40, 65, 73, 74)
    -15.20
    (3.006)
    -23.14
    (2.563)
    -23.31
    (2.446)
    -26.53
    (2.483)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.045
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -7.94
    Confidence Interval (2-Sided) 95%
    -15.72 to -0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.950
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.037
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -8.11
    Confidence Interval (2-Sided) 95%
    -15.73 to -0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.876
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -11.32
    Confidence Interval (2-Sided) 95%
    -19.00 to -3.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.899
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    16. Secondary Outcome
    Title Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169
    Description Participants responded to a question, "Considering all the ways your arthritis affects you, how are you feeling today?" by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly.
    Time Frame Baseline and Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Baseline (n=81, 81, 85, 79)
    64.86
    (1.892)
    63.79
    (2.074)
    63.71
    (1.957)
    62.39
    (2.099)
    Change at Day 169 (n=40, 65, 73, 74)
    -20.21
    (3.148)
    -21.06
    (2.685)
    -22.40
    (2.560)
    -25.69
    (2.600)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.837
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -0.85
    Confidence Interval (2-Sided) 95%
    -8.99 to 7.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.137
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.589
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -2.19
    Confidence Interval (2-Sided) 95%
    -10.18 to 5.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.058
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.180
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -5.48
    Confidence Interval (2-Sided) 95%
    -13.52 to 2.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.083
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    17. Secondary Outcome
    Title Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169
    Description Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 centimeter (cm) VAS, where 0 cm = very good and 10 cm = very bad.
    Time Frame Baseline and Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Baseline (n=81, 81, 85, 79)
    6.60
    (0.168)
    6.60
    (0.162)
    6.81
    (0.144)
    6.42
    (0.166)
    Change at Day 169 (n=40, 65, 73, 74)
    -2.39
    (0.305)
    -3.81
    (0.254)
    -3.85
    (0.241)
    -3.95
    (0.243)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -1.41
    Confidence Interval (2-Sided) 95%
    -2.20 to -0.63
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.397
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -1.46
    Confidence Interval (2-Sided) 95%
    -2.23 to -0.69
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.389
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -1.56
    Confidence Interval (2-Sided) 95%
    -2.33 to -0.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.391
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    18. Secondary Outcome
    Title Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169
    Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.
    Time Frame Baseline and Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Baseline (n=81, 80, 85, 79)
    1.63
    (0.054)
    1.52
    (0.070)
    1.58
    (0.056)
    1.58
    (0.059)
    Change at Day 169 (n=40, 65, 73, 74)
    -0.29
    (0.081)
    -0.37
    (0.072)
    -0.46
    (0.068)
    -0.55
    (0.069)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.479
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -0.08
    Confidence Interval (2-Sided) 95%
    -0.29 to 0.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.108
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.124
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -0.16
    Confidence Interval (2-Sided) 95%
    -0.37 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.106
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.017
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value -0.26
    Confidence Interval (2-Sided) 95%
    -0.47 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.107
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    19. Secondary Outcome
    Title Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169
    Description CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.
    Time Frame Baseline, Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "N" (Number of participants analyzed) signifies those participants who were evaluable for this measure.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 38 63 72 74
    Geometric Mean (Geometric Coefficient of Variation) [ratio]
    1.2971
    (83.3)
    0.8784
    (102.8)
    0.5197
    (287.4)
    0.5856
    (153.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.017
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted geometric mean ratio
    Estimated Value 0.64
    Confidence Interval (2-Sided) 95%
    0.45 to 0.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted geometric mean ratio
    Estimated Value 0.46
    Confidence Interval (2-Sided) 95%
    0.32 to 0.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted geometric mean ratio
    Estimated Value 0.44
    Confidence Interval (2-Sided) 95%
    0.31 to 0.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
    20. Secondary Outcome
    Title Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169
    Description ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.
    Time Frame Baseline, Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "N" (Number of participants analyzed) signifies those participants who were evaluable for this measure.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 40 64 73 74
    Geometric Mean (Geometric Coefficient of Variation) [ratio]
    0.89
    (57.0)
    0.67
    (56.4)
    0.62
    (55.3)
    0.58
    (61.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted geometric mean ratio
    Estimated Value 0.72
    Confidence Interval (2-Sided) 95%
    0.58 to 0.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted geometric mean ratio
    Estimated Value 0.68
    Confidence Interval (2-Sided) 95%
    0.55 to 0.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted geometric mean ratio
    Estimated Value 0.61
    Confidence Interval (2-Sided) 95%
    0.49 to 0.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.
    21. Secondary Outcome
    Title Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169
    Description The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Number [percentage of participants]
    1.2
    (0.054) 1.5%
    6.2
    (0.070) 7.7%
    2.4
    (0.056) 2.8%
    5.1
    (0.059) 6.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.210
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 4.9
    Confidence Interval (2-Sided) 95%
    -0.8 to 10.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 1.1
    Confidence Interval (2-Sided) 95%
    -2.9 to 5.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.207
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 3.8
    Confidence Interval (2-Sided) 95%
    -1.6 to 9.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
    22. Secondary Outcome
    Title Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169
    Description The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Number [percentage of participants]
    1.2
    (0.054) 1.5%
    6.2
    (0.070) 7.7%
    3.5
    (0.056) 4.1%
    7.6
    (0.059) 9.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.210
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 4.9
    Confidence Interval (2-Sided) 95%
    -0.8 to 10.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.621
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 2.3
    Confidence Interval (2-Sided) 95%
    -2.3 to 6.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.062
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 6.4
    Confidence Interval (2-Sided) 95%
    0.0 to 12.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
    23. Secondary Outcome
    Title Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169
    Description ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.
    Time Frame Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Number [percentage of participants]
    0.0
    (0.054) 0%
    3.7
    (0.070) 4.6%
    1.2
    (0.056) 1.4%
    1.3
    (0.059) 1.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.245
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 3.7
    Confidence Interval (2-Sided) 95%
    -0.4 to 7.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    -1.1 to 3.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.494
    Comments
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Percent difference
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    -1.2 to 3.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.
    24. Secondary Outcome
    Title Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169
    Description FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.
    Time Frame Baseline and Day 169

    Outcome Measure Data

    Analysis Population Description
    The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Baseline (n=79, 80, 84, 79)
    26.75
    (0.824)
    28.91
    (1.078)
    28.45
    (0.998)
    27.82
    (0.950)
    Change at Day 169 (n=40, 65, 73, 74)
    4.53
    (1.225)
    5.72
    (1.039)
    6.80
    (0.988)
    8.45
    (0.997)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 30 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.463
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value 1.18
    Confidence Interval (2-Sided) 95%
    -1.99 to 4.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.608
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences >0 favored mavrilimumab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 100 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.151
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value 2.27
    Confidence Interval (2-Sided) 95%
    -0.83 to 5.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.574
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences >0 favored mavrilimumab.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Mavrilimumab 150 mg
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.014
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Adjusted mean difference
    Estimated Value 3.92
    Confidence Interval (2-Sided) 95%
    0.81 to 7.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.578
    Estimation Comments An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences >0 favored mavrilimumab.
    25. Secondary Outcome
    Title Serum Concentrations of Mavrilimumab
    Description Serum concentrations after multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.
    Time Frame Baseline, Day 8, 15, 29, 85, 141, and 169

    Outcome Measure Data

    Analysis Population Description
    The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here "n" signifies participants who were evaluable for the specified time point for each arm, respectively.
    Arm/Group Title Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 85 79
    Baseline (n=80, 85, 79)
    0.00
    (894.4)
    0.00
    (NA)
    0.00
    (862.0)
    Day 8 (n=78, 83, 78)
    617.49
    (111.8)
    3563.31
    (49.3)
    6087.06
    (43.4)
    Day 15 (n=78, 84, 78)
    154.60
    (194.2)
    2479.96
    (52.1)
    4616.35
    (42.6)
    Day 29 (n=77, 85, 76)
    217.67
    (248.3)
    4503.97
    (54.8)
    7843.66
    (42.9)
    Day 85 (n=74, 81, 77)
    201.57
    (162.8)
    6538.22
    (52.7)
    13213.93
    (50.1)
    Day 141 (n=67, 75, 71)
    258.77
    (136.9)
    2932.80
    (75.6)
    9241.31
    (52.1)
    Day 169 (n=63, 73, 74)
    348.97
    (141.2)
    5282.37
    (62.0)
    9178.47
    (56.6)
    26. Secondary Outcome
    Title Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit
    Description Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.
    Time Frame Day 1 to Day 169

    Outcome Measure Data

    Analysis Population Description
    The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Measure Participants 81 81 85 79
    Number [percentage of participants]
    2.5
    3.1%
    16.0
    19.8%
    3.5
    4.1%
    0.0
    0%

    Adverse Events

    Time Frame Baseline up to Day 169
    Adverse Event Reporting Description
    Arm/Group Title Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Arm/Group Description Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    All Cause Mortality
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/81 (1.2%) 4/81 (4.9%) 5/85 (5.9%) 2/79 (2.5%)
    Cardiac disorders
    Atrial tachycardia 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Supraventricular tachycardia 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Gastrointestinal disorders
    Dyspepsia 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Hepatobiliary disorders
    Cholelithiasis 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Infections and infestations
    Pneumonia 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Injury, poisoning and procedural complications
    Lower limb fracture 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Tendon rupture 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Rheumatoid arthritis 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of the cervix 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Squamous cell carcinoma of lung 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Reproductive system and breast disorders
    Cystocele 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Skin and subcutaneous tissue disorders
    Angioedema 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Other (Not Including Serious) Adverse Events
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 38/81 (46.9%) 41/81 (50.6%) 36/85 (42.4%) 43/79 (54.4%)
    Blood and lymphatic system disorders
    Anaemia 1/81 (1.2%) 1 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Eosinophilia 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Leukocytosis 2/81 (2.5%) 2 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Lymphopenia 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Neutropenia 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 3/79 (3.8%) 4
    Cardiac disorders
    Arrhythmia supraventricular 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Cardiac failure 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Cardiovascular insufficiency 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Ear and labyrinth disorders
    Vertigo 0/81 (0%) 0 1/81 (1.2%) 1 1/85 (1.2%) 1 0/79 (0%) 0
    Endocrine disorders
    Hypothyroidism 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 1/79 (1.3%) 1
    Eye disorders
    Conjunctival haemorrhage 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Conjunctivitis 0/81 (0%) 0 0/81 (0%) 0 2/85 (2.4%) 2 0/79 (0%) 0
    Keratitis 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Abdominal pain upper 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Cheilitis 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Constipation 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Dental caries 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 1/79 (1.3%) 1
    Diarrhoea 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 2/79 (2.5%) 2
    Dyspepsia 1/81 (1.2%) 1 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Gastritis 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 2/79 (2.5%) 2
    Gingival swelling 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Haemorrhoids 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Irritable bowel syndrome 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Mouth cyst 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Nausea 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Vomiting 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    General disorders
    Fatigue 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Feeling hot 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Influenza like illness 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 1/79 (1.3%) 1
    Injection site erythema 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 3
    Injection site haematoma 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Injection site reaction 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Injection site swelling 1/81 (1.2%) 1 1/81 (1.2%) 2 0/85 (0%) 0 1/79 (1.3%) 2
    Oedema peripheral 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Pyrexia 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Hepatobiliary disorders
    Hypertransaminasaemia 0/81 (0%) 0 0/81 (0%) 0 2/85 (2.4%) 2 2/79 (2.5%) 2
    Immune system disorders
    Allergy to arthropod bite 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Drug hypersensitivity 1/81 (1.2%) 1 1/81 (1.2%) 1 0/85 (0%) 0 2/79 (2.5%) 2
    Hypersensitivity 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Infections and infestations
    Body tinea 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Bronchitis 6/81 (7.4%) 6 3/81 (3.7%) 3 1/85 (1.2%) 1 4/79 (5.1%) 4
    Cellulitis 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Cystitis 0/81 (0%) 0 1/81 (1.2%) 1 1/85 (1.2%) 1 0/79 (0%) 0
    Ear infection 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Escherichia urinary tract infection 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Fungal skin infection 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 1/79 (1.3%) 1
    Gastroenteritis 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 2/79 (2.5%) 2
    Gastrointestinal viral infection 2/81 (2.5%) 2 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Gingivitis 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Herpes simplex 2/81 (2.5%) 2 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Influenza 0/81 (0%) 0 1/81 (1.2%) 1 3/85 (3.5%) 3 1/79 (1.3%) 1
    Lyme disease 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Nasopharyngitis 6/81 (7.4%) 6 4/81 (4.9%) 5 3/85 (3.5%) 4 6/79 (7.6%) 6
    Omphalitis 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Periodontitis 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Pharyngitis 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 1/79 (1.3%) 1
    Pneumonia 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Respiratory tract infection viral 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 1/79 (1.3%) 1
    Rhinitis 0/81 (0%) 0 2/81 (2.5%) 2 0/85 (0%) 0 2/79 (2.5%) 2
    Sinusitis 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Skin infection 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Tinea pedis 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Tinea versicolour 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Tonsillitis 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Upper respiratory tract infection 1/81 (1.2%) 1 2/81 (2.5%) 2 1/85 (1.2%) 1 1/79 (1.3%) 1
    Urinary tract infection 1/81 (1.2%) 1 2/81 (2.5%) 2 1/85 (1.2%) 1 1/79 (1.3%) 1
    Viral upper respiratory tract infection 0/81 (0%) 0 2/81 (2.5%) 2 1/85 (1.2%) 1 1/79 (1.3%) 1
    Injury, poisoning and procedural complications
    Alcohol poisoning 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Animal bite 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Bone contusion 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Chemical poisoning 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Clavicle fracture 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Contusion 1/81 (1.2%) 1 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Epicondylitis 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Fall 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Injection related reaction 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Laceration 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Limb injury 0/81 (0%) 0 0/81 (0%) 0 2/85 (2.4%) 2 0/79 (0%) 0
    Muscle contusion 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 1/79 (1.3%) 1
    Investigations
    Alanine aminotransferase increased 0/81 (0%) 0 1/81 (1.2%) 1 1/85 (1.2%) 1 1/79 (1.3%) 1
    Aspartate aminotransferase increased 0/81 (0%) 0 1/81 (1.2%) 1 1/85 (1.2%) 1 0/79 (0%) 0
    Blood pressure increased 1/81 (1.2%) 2 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Gamma-glutamyltransferase increased 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Weight increased 1/81 (1.2%) 1 1/81 (1.2%) 1 1/85 (1.2%) 1 0/79 (0%) 0
    Metabolism and nutrition disorders
    Dyslipidaemia 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Hypercholesterolaemia 1/81 (1.2%) 1 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Hyperkalaemia 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Hyperlipidaemia 0/81 (0%) 0 2/81 (2.5%) 2 0/85 (0%) 0 3/79 (3.8%) 3
    Musculoskeletal and connective tissue disorders
    Back pain 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Joint swelling 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Muscle spasms 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Osteoarthritis 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Pain in extremity 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Rheumatoid arthritis 4/81 (4.9%) 6 2/81 (2.5%) 3 2/85 (2.4%) 2 0/79 (0%) 0
    Rheumatoid nodule 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Rotator cuff syndrome 0/81 (0%) 0 1/81 (1.2%) 1 1/85 (1.2%) 1 0/79 (0%) 0
    Sjogren's syndrome 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Spinal osteoarthritis 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Spinal pain 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Tendonitis 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Nervous system disorders
    Headache 2/81 (2.5%) 2 5/81 (6.2%) 5 4/85 (4.7%) 4 6/79 (7.6%) 8
    Intercostal neuralgia 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Sciatica 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Psychiatric disorders
    Anxiety 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Depression 0/81 (0%) 0 2/81 (2.5%) 2 0/85 (0%) 0 1/79 (1.3%) 1
    Dyssomnia 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Insomnia 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Renal and urinary disorders
    Nephrolithiasis 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Renal colic 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Reproductive system and breast disorders
    Cervical dysplasia 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Endometriosis 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Uterine polyp 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Vaginal discharge 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Bronchospasm 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Chronic obstructive pulmonary disease 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Cough 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Obstructive airways disorder 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Oropharyngeal pain 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Pleural effusion 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Pulmonary mass 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Rhinorrhoea 1/81 (1.2%) 2 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Dermatitis contact 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Erythema 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Hyperhidrosis 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Intertrigo 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Pruritus 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 2/79 (2.5%) 2
    Rash 1/81 (1.2%) 1 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Urticaria 0/81 (0%) 0 0/81 (0%) 0 0/85 (0%) 0 1/79 (1.3%) 1
    Vascular disorders
    Haematoma 0/81 (0%) 0 1/81 (1.2%) 1 0/85 (0%) 0 0/79 (0%) 0
    Hot flush 0/81 (0%) 0 0/81 (0%) 0 1/85 (1.2%) 1 0/79 (0%) 0
    Hypertension 2/81 (2.5%) 2 4/81 (4.9%) 4 4/85 (4.7%) 5 3/79 (3.8%) 3
    Venous insufficiency 1/81 (1.2%) 1 0/81 (0%) 0 0/85 (0%) 0 0/79 (0%) 0

    Limitations/Caveats

    Non-compartmental analyses was not performed for pharmacokinetics parameters due to limited sampling schedule

    More Information

    Certain Agreements

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

    MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.

    Results Point of Contact

    Name/Title Marius Albulescu, Associate Medical Director
    Organization MedImmune, LLC
    Phone 301-398-0000
    Email albulescum@medimmune.com
    Responsible Party:
    MedImmune LLC
    ClinicalTrials.gov Identifier:
    NCT01706926
    Other Study ID Numbers:
    • CD-IA-CAM-3001-1071
    First Posted:
    Oct 15, 2012
    Last Update Posted:
    Sep 27, 2016
    Last Verified:
    Aug 1, 2016