Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

• Sponsor: Sanofi (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03600805
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 83
• Locations: 61
• Arms: 4
• Actual Duration (Months): 24.1
• Patients Per Site: 1.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Primary Objective:

To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course.

Secondary Objective:

• To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to:

• Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time.

• Cumulative CS (including prednisone) exposure.

• To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with GCA.

• To measure sarilumab serum concentrations in participants with GCA.

• To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

Condition or Disease	Intervention/Treatment	Phase
Giant Cell Arteritis	Drug: Sarilumab SAR153191; Drug: Sarilumab matching placebo; Drug: Prednisone; Drug: Prednisone matching placebo	Phase 3

Detailed Description

Study duration per participant was approximately 82 weeks, including an up to 6-week screening period, 52-week treatment period, and 24-week follow-up period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis
• Actual Study Start Date: Nov 20, 2018
• Actual Primary Completion Date: Nov 24, 2020
• Actual Study Completion Date: Nov 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Placebo+52 Week Taper Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Drug: Sarilumab matching placebo; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Drug: Prednisone; Pharmaceutical form: tablets or capsules Route of administration: oral administration; Drug: Prednisone matching placebo; Pharmaceutical form: capsules Route of administration: oral administration
Experimental: Placebo+26 Week Taper Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Drug: Sarilumab matching placebo; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Drug: Prednisone; Pharmaceutical form: tablets or capsules Route of administration: oral administration; Drug: Prednisone matching placebo; Pharmaceutical form: capsules Route of administration: oral administration
Placebo Comparator: Sarilumab 150mg q2w+26 Week Taper Participants received sarilumab 150 milligrams (mg) as SC injection q2w up to 52 weeks along with prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Drug: Sarilumab SAR153191; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Drug: Prednisone; Pharmaceutical form: tablets or capsules Route of administration: oral administration; Drug: Prednisone matching placebo; Pharmaceutical form: capsules Route of administration: oral administration
Placebo Comparator: Sarilumab 200mg q2w+26 Week Taper Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Drug: Sarilumab SAR153191; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Drug: Prednisone; Pharmaceutical form: tablets or capsules Route of administration: oral administration; Drug: Prednisone matching placebo; Pharmaceutical form: capsules Route of administration: oral administration

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Achieved Sustained Disease Remission at Week 52 [At Week 52]

   Disease remission was defined as resolution of signs and symptoms of giant cell arteries (GCA), and normalization of C-reactive protein (CRP) (<10 mg/L). Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in corticosteroid [CS] dose due to GCA or elevation of erythrocyte sedimentation rate [ESR] attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 52, normalization of CRP (to <10 mg/L, with absence of successive elevations to >=10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52.

2. Percentage of Participants Who Achieved Sustained Disease Remission at Week 24 [At Week 24]

   Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP <10 mg/L. Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 24, normalization of CRP (to <10 mg/L, with an absence of successive elevations to >=10 mg/L) from Week 12 through Week 24, and successful adherence to the prednisone taper from Week 12 through Week 24.

Secondary Outcome Measures

1. Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set [Up to Week 12]

   Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue corticosteroid (CS) due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12.

2. Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population [Up to Week 12]

   Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue CS due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12.

3. Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set [From Week 12 through Week 52]

   Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 52 were reported.

4. Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population [From Week 12 through Week 24]

   Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 24 were reported.

5. Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set [From Week 12 through Week 52]

   Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP.

6. Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population [From Week 12 through Week 24]

   Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP.

7. Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set [From Week 12 through Week 52]

   Successful adherence to the prednisone taper from Week 12 through Week 52 was defined as participants who did not take rescue therapy from Week 12 through Week 52 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage adverse event (AE) not related to GCA.

8. Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population [From Week 12 through Week 24]

   Successful adherence to the prednisone taper from Week 12 through Week 24 was defined as participants who did not take rescue therapy from Week 12 through Week 24 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage AE not related to GCA.

9. Total Cumulative Corticosteroid (Including Prednisone) Dose [Up to Week 52]

   Cumulative dose of CS used for GCA disease was defined as the dose taken up to the end of treatment, including expected prednisone in tapering regimen per protocol, CS used in rescue therapy and the use of commercial prednisone (an excess of <=100 mg of prednisone during the study treatment period employed to manage AE not related to GCA). The total cumulative CS dose was based on the total number of days with complete or partial intake, no imputation was done on missed tablets.

10. Time to First Giant Cell Arteritis Disease Flare [Up to Week 52]

    Time to first GCA flare was defined as the duration (in days) from randomization to first GCA flare after clinical remission (defined as resolution of signs and symptoms and normalization of CRP [<10 mg/L]) and up to 52 weeks. Disease flare was defined as either the recurrence of signs or symptoms attributable to active plus an increase in CS dose due to GCA or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Kaplan-Meier method was used for the analysis. Participants who never achieved remission were censored at randomization day; and those who achieved clinical remission and never flared were censored at the end of treatment assessment date up to Week 52.

11. Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population [At Week 24]

    GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 24 are reported in this outcome measure (OM). CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity.

12. Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52 [At Week 52]

    GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 52 are reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity.

13. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [From first dose (i.e., Day 1) up to 60 days after last dose (i.e., up to Week 60)]

    An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product (IMP) to the last dose of the SC IMP +60 days).

14. Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab [Pre-dose on Week 0 (Baseline), Weeks 2, 4, 12, 16, 24 and 52]

    Ctrough was pre dose concentration of drug. Data for this outcome measure was not planned to be collected and analyzed for placebo arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol.

15. Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24 [post-dose at Week 24]

    Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay.

16. Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response [From Day 1 (Baseline) up to last dose date of study drug + 60 days (i.e., up to Week 60)]

    ADA response categories: 1) Treatment-boosted ADA positive participant: Participant with a positive ADA assay response at Baseline and with at least a 4-fold increase in titer compared to Baseline during TEAE period. 2) Treatment-emergent ADA positive participant: Participant with non-positive assay (meaning negative or missing) response at Baseline but with a positive assay response during the TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Titer values were categorized as low (titer <1,000); moderate (1,000<= titer <=10,000) and high (titer >10,000).

17. Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 [Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    ESR is a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeters per hour.

18. Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 [Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    CRP is a protein made by the liver. CRP levels increase in blood when inflammation occurs in the body.

19. Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52 [Baseline, Weeks 2, 12, 24, and 52]

    Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic.

20. Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52 [Baseline, Weeks 2, 12, 24, and 52]

    Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. sIL-6R is one of the receptors that bind IL-6.

Eligibility Criteria

Criteria

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

Inclusion criteria :

• Diagnosis of GCA according to European League Against Rheumatism/American College of Rheumatology classification criteria.

• New onset active disease or refractory active disease.

• At least one of the symptoms of GCA within 6 weeks of baseline.

• Either erythrocyte sedimentation rate greater than or equal to (>=) 30 millimeter per hour or C-reactive protein >=10 mg per liter within 6 weeks of baseline.

• Received or were able to receive prednisone 20-60 mg/day for the treatment of active GCA.

Exclusion criteria:

• Organ transplantation recipient (except corneas, unless it is within 3 months prior to baseline visit).

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

• Any prior use of the following therapies, for the treatment of GCA:

• Janus kinase inhibitor (e.g., tofacitinib) within 4 weeks of baseline.

• Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to baseline level.

• Abatacept within 8 weeks of baseline.

• Anakinra within 1 week of baseline.

• Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks; infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or less than at least 5 half-lives had elapsed prior to baseline, whichever was longer.

• Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological Interleukin 6 (IL-6) IL-6/(R) antagonist (prior experience with IL-6/(R) antagonist that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline was not exclusionary).

• Use of any alkylating agents including cyclophosphamide within 6 months of baseline.

• Use of immunosuppressant, such as hydroxychloroquine, cyclosporine, azathioprine, mycophenolate mofetil or leflunomide within 4 weeks of baseline. (Use of methotrexate (MTX) not exceeding 25 mg per week and had been stable for at least 3 months prior to baseline was not exclusionary).

• Concurrent use of systemic CS for conditions other than GCA.

• Use of intervascular CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8 weeks of baseline for GCA therapy.

• Pregnant or breastfeeding woman.

• Participants with active or untreated latent tuberculosis.

• Participants with history of invasive opportunistic infections.

• Participants with fever associated with infection or chronic, persistent or recurring infections requiring active treatment.

• Participants with uncontrolled diabetes mellitus.

• Participants with non-healed or healing skin ulcers.

• Participants who received any live, attenuated vaccine within 3 months of baseline.

• Participants who are positive for hepatitis B, hepatitis C and/or HIV.

• Participants with a history of active or recurrent herpes zoster.

• Participants with a history of or prior articular or prosthetic joint infection.

• Prior or current history of malignancy.

• Participants who have had surgery within 4 weeks of screening or planned surgery during study.

• Participants with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation..

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 8400002	Boca Raton	Florida	United States	33486
2	Investigational Site Number 8400017	Gainesville	Florida	United States	32608
3	Investigational Site Number 8400014	Iowa City	Iowa	United States	52242
4	Investigational Site Number 8400018	Portland	Oregon	United States	97239
5	Investigational Site Number 8400019	Philadelphia	Pennsylvania	United States	19104
6	Investigational Site Number 8400011	Dallas	Texas	United States	75231
7	Investigational Site Number 0320001	Buenos Aires		Argentina	C1015ABO
8	Investigational Site Number 0320002	Caba		Argentina	C1181ACH
9	Investigational Site Number 0360003	Camberwell		Australia	3124
10	Investigational Site Number 0360006	Clayton		Australia	3168
11	Investigational Site Number 0360001	Kogarah		Australia	2217
12	Investigational Site Number 0560001	Leuven		Belgium	3000
13	Investigational Site Number 1240007	Hamilton		Canada	L8N 4A6
14	Investigational Site Number 1240010	Montreal		Canada	H4A 3T2
15	Investigational Site Number 1240001	Rimouski		Canada	G5L 5T1
16	Investigational Site Number 1240005	Sherbrooke		Canada	J1G 2E8
17	Investigational Site Number 1240003	Trois-Rivières		Canada	G8Z 1Y2
18	Investigational Site Number 1910001	Zagreb		Croatia	10000
19	Investigational Site Number 2080002	Aarhus C		Denmark	8000
20	Investigational Site Number 2080003	Svendborg		Denmark	5700
21	Investigational Site Number 2330001	Tallinn		Estonia	13419
22	Investigational Site Number 2500005	Brest Cedex		France	29609
23	Investigational Site Number 2500002	Montivilliers		France	76290
24	Investigational Site Number 2500003	Montpellier		France	34295
25	Investigational Site Number 2500007	Mulhouse		France	68100
26	Investigational Site Number 2500001	Paris		France	75014
27	Investigational Site Number 2500006	Pessac		France	33604
28	Investigational Site Number 2760001	Berlin		Germany	13125
29	Investigational Site Number 2760002	Dresden		Germany	01307
30	Investigational Site Number 2760003	Kirchheim Unter Teck		Germany	73230
31	Investigational Site Number 2760004	München		Germany	80336
32	Investigational Site Number 2760007	Tübingen		Germany	72076
33	Investigational Site Number 3480001	Debrecen		Hungary	4032
34	Investigational Site Number 3760006	Ashkelon		Israel	78278
35	Investigational Site Number 3760004	Haifa		Israel	34362
36	Investigational Site Number 3800001	Milano		Italy	20132
37	Investigational Site Number 3800005	Rozzano		Italy	20089
38	Investigational Site Number 5280007	Den Haag		Netherlands	2545 CH
39	Investigational Site Number 5280005	Leeuwarden		Netherlands	8934 AD
40	Investigational Site Number 5280009	Sittard-Geleen		Netherlands	6162 BG
41	Investigational Site Number 5280001	Venlo		Netherlands	5912 BL
42	Investigational Site Number 6200001	Almada		Portugal	2801-951
43	Investigational Site Number 6200005	Aveiro		Portugal	3810-501
44	Investigational Site Number 6200004	Ponte De Lima		Portugal	4990-041
45	Investigational Site Number 6430005	Kemerovo		Russian Federation	650000
46	Investigational Site Number 6430002	Moscow		Russian Federation	115404
47	Investigational Site Number 6430003	Moscow		Russian Federation	123182
48	Investigational Site Number 7050001	Ljubljana		Slovenia	1000
49	Investigational Site Number 7240010	Bilbao		Spain	48013
50	Investigational Site Number 7240011	La Coruña		Spain	15006
51	Investigational Site Number 7240014	Madrid		Spain	28046
52	Investigational Site Number 7240016	Sabadell		Spain	08208
53	Investigational Site Number 7240015	Santa Cruz De Tenerife		Spain	38320
54	Investigational Site Number 7520001	Uppsala		Sweden	751 85
55	Investigational Site Number 7520003	Örebro		Sweden	701 85
56	Investigational Site Number 7560002	St. Gallen		Switzerland	9007
57	Investigational Site Number 8260006	Aberdeen		United Kingdom	AB25 2ZN
58	Investigational Site Number 8260004	Gateshead		United Kingdom	NE9 6SX
59	Investigational Site Number 8260003	Leeds		United Kingdom	LS7 4SA
60	Investigational Site Number 8260005	Manchester		United Kingdom	M13 9WL
61	Investigational Site Number 8260011	Portsmouth		United Kingdom	PO6 3LY

Sponsors and Collaborators

• Sanofi
• Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

• Study Protocol - Sep 12, 2018
• Statistical Analysis Plan - Jan 8, 2021

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT03600805
• Other Study ID Numbers: EFC15068; 2017-002988-18; U1111-1200-2184
• First Posted: Jul 26, 2018
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis; Prednisone

Study Results

Participant Flow

Recruitment Details	Study was conducted at 48 active centers in 19 countries. A total of 125 participants were screened between 20 November 2018 and 19 March 2020, of whom 42 participants were screen failures. Screen failures were mainly due to not meeting inclusion criteria. A total of 83 participants were enrolled and randomized in the study.
Pre-assignment Detail	Participants were randomized to 4 treatments arms in 2:1:1:2 ratio by interactive response technology stratified by starting dose of prednisone at Baseline (less than [<] 30 milligrams per day (mg/day) or greater than or equal to [>=] 30 mg/day).

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Period Title: Overall Study
STARTED	28	14	14	27
Week 52 Analysis Set Population	10	6	7	13
COMPLETED	9	6	6	8
NOT COMPLETED	19	8	8	19

Baseline Characteristics

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper	Total Title
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Overall Participants	28	14	14	27	83
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.4 (7.7)	69.5 (5.4)	67.1 (7.9)	73.4 (8.6)	71.0 (7.9)
Sex: Female, Male (Count of Participants)
Female	22 78.6%	9 64.3%	13 92.9%	23 85.2%	67 80.7%
Male	6 21.4%	5 35.7%	1 7.1%	4 14.8%	16 19.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	1 7.1%	0 0%	1 1.2%
White	23 82.1%	13 92.9%	11 78.6%	25 92.6%	72 86.7%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	5 17.9%	1 7.1%	2 14.3%	2 7.4%	10 12%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved Sustained Disease Remission at Week 52
Description	Disease remission was defined as resolution of signs and symptoms of giant cell arteries (GCA), and normalization of C-reactive protein (CRP) (<10 mg/L). Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in corticosteroid [CS] dose due to GCA or elevation of erythrocyte sedimentation rate [ESR] attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 52, normalization of CRP (to <10 mg/L, with absence of successive elevations to >=10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52.
Time Frame	At Week 52

Outcome Measure Data

Analysis Population Description

Analysis was performed on Week 52 analysis set population that included randomized participants who had opportunity to complete the 52-week treatment period (randomized prior to October 16th, 2019).

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	10	6	7	13
Number [percentage of participants]	30.0 107.1%	0 0%	42.9 306.4%	46.2 171.1%

2. Primary Outcome

Title	Percentage of Participants Who Achieved Sustained Disease Remission at Week 24
Description	Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP <10 mg/L. Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 24, normalization of CRP (to <10 mg/L, with an absence of successive elevations to >=10 mg/L) from Week 12 through Week 24, and successful adherence to the prednisone taper from Week 12 through Week 24.
Time Frame	At Week 24

Outcome Measure Data

Analysis Population Description

Analysis was performed on intent-to-treat (ITT) population that included participants who were allocated to a randomized treatment regardless of whether the treatment kit was used, and were analyzed according to the treatment group allocated by randomization.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Number [percentage of participants]	39.3 140.4%	7.1 50.7%	42.9 306.4%	48.1 178.1%

3. Secondary Outcome

Title	Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set
Description	Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue corticosteroid (CS) due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

Analysis was performed on Week 52 analysis set.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	10	6	7	13
Count of Participants [Participants]	7 25%	3 21.4%	4 28.6%	7 25.9%

4. Secondary Outcome

Title	Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population
Description	Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue CS due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Count of Participants [Participants]	16 57.1%	6 42.9%	9 64.3%	15 55.6%

5. Secondary Outcome

Title	Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set
Description	Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 52 were reported.
Time Frame	From Week 12 through Week 52

Outcome Measure Data

Analysis Population Description

Analysis was performed on Week 52 analysis set.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	10	6	7	13
Count of Participants [Participants]	7 25%	3 21.4%	4 28.6%	7 25.9%

6. Secondary Outcome

Title	Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population
Description	Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 24 were reported.
Time Frame	From Week 12 through Week 24

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Count of Participants [Participants]	21 75%	7 50%	10 71.4%	15 55.6%

7. Secondary Outcome

Title	Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set
Description	Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP.
Time Frame	From Week 12 through Week 52

Outcome Measure Data

Analysis Population Description

Analysis was performed on Week 52 analysis set.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	10	6	7	13
Count of Participants [Participants]	6 21.4%	3 21.4%	5 35.7%	8 29.6%

8. Secondary Outcome

Title	Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population
Description	Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP.
Time Frame	From Week 12 through Week 24

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Count of Participants [Participants]	20 71.4%	4 28.6%	11 78.6%	17 63%

9. Secondary Outcome

Title	Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set
Description	Successful adherence to the prednisone taper from Week 12 through Week 52 was defined as participants who did not take rescue therapy from Week 12 through Week 52 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage adverse event (AE) not related to GCA.
Time Frame	From Week 12 through Week 52

Outcome Measure Data

Analysis Population Description

Analysis was performed on Week 52 analysis set.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	10	6	7	13
Count of Participants [Participants]	6 21.4%	2 14.3%	3 21.4%	6 22.2%

10. Secondary Outcome

Title	Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population
Description	Successful adherence to the prednisone taper from Week 12 through Week 24 was defined as participants who did not take rescue therapy from Week 12 through Week 24 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage AE not related to GCA.
Time Frame	From Week 12 through Week 24

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Count of Participants [Participants]	18 64.3%	5 35.7%	7 50%	13 48.1%

11. Secondary Outcome

Title	Total Cumulative Corticosteroid (Including Prednisone) Dose
Description	Cumulative dose of CS used for GCA disease was defined as the dose taken up to the end of treatment, including expected prednisone in tapering regimen per protocol, CS used in rescue therapy and the use of commercial prednisone (an excess of <=100 mg of prednisone during the study treatment period employed to manage AE not related to GCA). The total cumulative CS dose was based on the total number of days with complete or partial intake, no imputation was done on missed tablets.
Time Frame	Up to Week 52

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Mean (Standard Deviation) [milligrams]	2577.3 (1018.3)	2270.7 (1418.0)	2177.1 (1326.7)	1643.1 (967.3)

12. Secondary Outcome

Title	Time to First Giant Cell Arteritis Disease Flare
Description	Time to first GCA flare was defined as the duration (in days) from randomization to first GCA flare after clinical remission (defined as resolution of signs and symptoms and normalization of CRP [<10 mg/L]) and up to 52 weeks. Disease flare was defined as either the recurrence of signs or symptoms attributable to active plus an increase in CS dose due to GCA or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Kaplan-Meier method was used for the analysis. Participants who never achieved remission were censored at randomization day; and those who achieved clinical remission and never flared were censored at the end of treatment assessment date up to Week 52.
Time Frame	Up to Week 52

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Median (95% Confidence Interval) [days]	NA	170.00	NA	NA

13. Secondary Outcome

Title	Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population
Description	GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 24 are reported in this outcome measure (OM). CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity.
Time Frame	At Week 24

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Cumulative worsening score	29.2 (30.8)	30.7 (33.2)	55.1 (43.1)	31.0 (42.9)
Aggregate improvement score	-21.6 (54.8)	-13.4 (44.3)	14.2 (55.0)	-3.3 (43.4)

14. Secondary Outcome

Title	Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52
Description	GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 52 are reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity.
Time Frame	At Week 52

Outcome Measure Data

Analysis Population Description

Analysis was performed on Week 52 analysis set. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	10	6	6	11
Cumulative worsening score	73.0 (50.3)	84.7 (33.4)	77.2 (41.7)	52.8 (39.0)
Aggregate improvement score	-19.5 (65.0)	31.2 (54.7)	23.7 (31.9)	-0.5 (51.5)

15. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Description	An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product (IMP) to the last dose of the SC IMP +60 days).
Time Frame	From first dose (i.e., Day 1) up to 60 days after last dose (i.e., up to Week 60)

Outcome Measure Data

Analysis Population Description

Analysis was performed on safety population that included participants who had received at least one dose or part of a dose of IMP and were analyzed according to the treatment actually received.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Any TEAE	24 85.7%	14 100%	13 92.9%	22 81.5%
Any treatment emergent SAE	2 7.1%	3 21.4%	2 14.3%	7 25.9%

16. Secondary Outcome

Title	Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab
Description	Ctrough was pre dose concentration of drug. Data for this outcome measure was not planned to be collected and analyzed for placebo arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol.
Time Frame	Pre-dose on Week 0 (Baseline), Weeks 2, 4, 12, 16, 24 and 52

Outcome Measure Data

Analysis Population Description

Analyzed on PK analysis population: participants who had received at least one dose or part of a dose of IMP, were analyzed according to the treatment actually received and had at least 1 post-dose non-missing serum sarilumab concentration value. Here, 'Number Analyzed' = participants with available data for each specified category.

Arm/Group Title	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	14	26
Baseline	0.00 (0.00)	0.00 (0.00)
Week 2	2099.29 (3114.92)	5400.82 (4124.63)
Week 4	4644.71 (5994.17)	11640.98 (8574.00)
Week 12	8371.33 (7608.42)	27586.00 (17496.07)
Week 16	8111.08 (5962.56)	28911.88 (20821.06)
Week 24	12926.67 (9509.92)	35451.74 (23953.29)
Week 52	19780.00 (21829.95)	46766.67 (21172.15)

17. Secondary Outcome

Title	Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24
Description	Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay.
Time Frame	post-dose at Week 24

Outcome Measure Data

Analysis Population Description

Analysis was performed on PK analysis population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol.

Arm/Group Title	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	11	13
Mean (Standard Deviation) [nanograms per milliliter]	25255.45 (17510.38)	44551.54 (28298.62)

18. Secondary Outcome

Title	Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response
Description	ADA response categories: 1) Treatment-boosted ADA positive participant: Participant with a positive ADA assay response at Baseline and with at least a 4-fold increase in titer compared to Baseline during TEAE period. 2) Treatment-emergent ADA positive participant: Participant with non-positive assay (meaning negative or missing) response at Baseline but with a positive assay response during the TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Titer values were categorized as low (titer <1,000); moderate (1,000<= titer <=10,000) and high (titer >10,000).
Time Frame	From Day 1 (Baseline) up to last dose date of study drug + 60 days (i.e., up to Week 60)

Outcome Measure Data

Analysis Population Description

Analysis was performed on ADA population that included participants who had received at least one dose or part of a dose of IMP, were analyzed according to the treatment actually received and had at least 1 non-missing ADA result in the ADA assay following the first dose of IMP.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	26	13	14	24
Treatment-boosted ADA positive participants	0 0%	0 0%	0 0%	0 0%
Treatment-emergent ADA positive participants	3.8 13.6%	0 0%	7.1 50.7%	0 0%

19. Secondary Outcome

Title	Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
Description	ESR is a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeters per hour.
Time Frame	Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population. Here, 'number analyzed' = participants with available data for each specified category.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Baseline	29.3 (27.3)	21.9 (16.2)	24.9 (22.0)	18.2 (16.8)
Week 2	-1.1 (17.9)	0.7 (11.4)	-10.4 (16.4)	-8.8 (12.4)
Week 4	-4.2 (21.4)	5.2 (19.7)	-13.3 (22.6)	-9.4 (15.2)
Week 8	-2.0 (22.7)	10.2 (12.6)	-11.9 (18.9)	-8.7 (16.1)
Week 12	-1.5 (24.9)	9.8 (13.3)	-14.7 (19.2)	-11.0 (14.1)
Week 16	-4.1 (22.7)	9.8 (16.5)	-13.5 (18.1)	-10.4 (12.7)
Week 20	-6.6 (23.7)	8.8 (14.6)	-18.2 (23.5)	-10.9 (12.2)
Week 24	-4.2 (22.0)	13.9 (16.1)	-16.4 (25.6)	-9.3 (11.5)
Week 32	-7.0 (21.3)	6.6 (16.2)	-9.4 (18.0)	-7.9 (10.6)
Week 40	-1.5 (22.3)	4.0 (18.1)	-10.1 (25.2)	-7.9 (8.6)
Week 52	-1.0 (27.0)	-1.4 (12.4)	-15.2 (19.0)	-7.0 (12.0)

20. Secondary Outcome

Title	Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
Description	CRP is a protein made by the liver. CRP levels increase in blood when inflammation occurs in the body.
Time Frame	Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population. Here, 'number analyzed' = participants with available data for each specified category.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Baseline	10.9 (20.0)	9.7 (18.3)	10.1 (12.4)	3.7 (6.2)
Week 2	0.4 (21.0)	-1.0 (21.2)	-3.5 (11.2)	-2.0 (7.6)
Week 4	-3.6 (19.3)	-2.2 (21.8)	-2.6 (18.7)	-1.9 (8.3)
Week 8	-4.0 (19.5)	-0.9 (17.0)	-3.5 (11.7)	-1.7 (5.5)
Week 12	-4.4 (22.0)	4.4 (18.9)	-3.3 (17.9)	-1.1 (8.4)
Week 16	-4.5 (20.7)	5.0 (23.9)	-5.0 (14.1)	-1.8 (3.0)
Week 20	-4.5 (21.1)	0.6 (17.6)	-4.9 (13.6)	-1.6 (2.9)
Week 24	-4.1 (19.5)	0.3 (32.6)	-3.1 (18.3)	-1.0 (4.5)
Week 32	-5.2 (19.6)	1.1 (35.4)	-5.8 (17.1)	-0.4 (6.5)
Week 40	-1.9 (22.3)	-9.2 (27.0)	-2.2 (11.1)	-2.8 (3.5)
Week 52	8.2 (27.4)	-13.8 (37.0)	-4.5 (5.2)	-4.6 (4.4)

21. Secondary Outcome

Title	Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52
Description	Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic.
Time Frame	Baseline, Weeks 2, 12, 24, and 52

Outcome Measure Data

Analysis Population Description

Analysis was performed on safety population. Here, 'number analyzed' = participants with available data for each specified category.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Baseline	10.91 (12.85)	8.74 (5.78)	11.03 (15.33)	7.71 (7.30)
Week 2	2.90 (17.46)	3.47 (10.30)	31.74 (31.13)	117.33 (245.28)
Week 12	-0.88 (12.60)	5.56 (8.08)	52.38 (47.46)	81.82 (50.85)
Week 24	-1.03 (7.15)	5.57 (19.81)	53.60 (53.71)	69.20 (46.89)
Week 52	0.43 (5.58)	2.82 (1.90)	42.14 (8.52)	33.28 (32.37)

22. Secondary Outcome

Title	Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52
Description	Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. sIL-6R is one of the receptors that bind IL-6.
Time Frame	Baseline, Weeks 2, 12, 24, and 52

Outcome Measure Data

Analysis Population Description

Analyzed on safety population. Here, 'Number Analyzed'=participants with available data for each specified category and '0' in number analyzed field signifies that no participants were available for assessments at specified time points in the respective arm.

Arm/Group Title	Placebo+52 Week Taper	Placebo+26 Week Taper	Sarilumab 150mg q2w+26 Week Taper	Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Measure Participants	28	14	14	27
Baseline	136.63 (260.57)	54.80 (18.48)	50.05 (17.84)	61.37 (72.43)
Week 2	212.19 (51.99)	224.87 (107.43)
Week 12	17.67	336.30 (107.49)	427.40 (124.97)
Week 24	-12.72 (3.97)	311.88 (184.32)	456.09 (118.07)
Week 52	-131.47 (356.65)	-9.69 (11.14)	377.23 (84.99)	471.16 (182.72)

Adverse Events

Time Frame	From first dose (i.e., Day 1) of study drug to last dose date of study drug + 60 days (i.e., up to Week 60)
Adverse Event Reporting Description	Reported AEs and deaths were treatment emergent AEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Arm/Group Title	Placebo+52 Week Taper		Placebo+26 Week Taper		Sarilumab 150mg q2w+26 Week Taper		Sarilumab 200mg q2w+26 Week Taper
Arm/Group Description	Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.		Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.		Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.		Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
All Cause Mortality
	Placebo+52 Week Taper		Placebo+26 Week Taper		Sarilumab 150mg q2w+26 Week Taper		Sarilumab 200mg q2w+26 Week Taper
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		1/14 (7.1%)		0/14 (0%)		2/27 (7.4%)
Serious Adverse Events
	Placebo+52 Week Taper		Placebo+26 Week Taper		Sarilumab 150mg q2w+26 Week Taper		Sarilumab 200mg q2w+26 Week Taper
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/28 (7.1%)		3/14 (21.4%)		2/14 (14.3%)		7/27 (25.9%)
Blood and lymphatic system disorders
Neutropenia	0/28 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	2/27 (7.4%)	2
Eye disorders
Blindness Unilateral	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Retinal Artery Occlusion	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Gastrointestinal disorders
Colitis Ulcerative	1/28 (3.6%)	1	0/14 (0%)	0	0/14 (0%)	0	0/27 (0%)	0
Hiatus Hernia	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Infections and infestations
Covid-19	0/28 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/27 (3.7%)	1
Cellulitis	0/28 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/27 (3.7%)	1
Lower Respiratory Tract Infection	1/28 (3.6%)	1	0/14 (0%)	0	0/14 (0%)	0	0/27 (0%)	0
Pyelonephritis	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Septic Shock	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Urosepsis	0/28 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/27 (3.7%)	1
Injury, poisoning and procedural complications
Femur Fracture	0/28 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/27 (3.7%)	1
Nervous system disorders
Cerebral Amyloid Angiopathy	0/28 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/27 (3.7%)	1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Vascular disorders
Aortic Dissection	0/28 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/27 (3.7%)	1
Deep Vein Thrombosis	1/28 (3.6%)	1	0/14 (0%)	0	0/14 (0%)	0	0/27 (0%)	0
Peripheral Vascular Disorder	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo+52 Week Taper		Placebo+26 Week Taper		Sarilumab 150mg q2w+26 Week Taper		Sarilumab 200mg q2w+26 Week Taper
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/28 (78.6%)		13/14 (92.9%)		13/14 (92.9%)		20/27 (74.1%)
Blood and lymphatic system disorders
Increased Tendency To Bruise	5/28 (17.9%)	5	3/14 (21.4%)	3	3/14 (21.4%)	3	3/27 (11.1%)	4
Neutropenia	0/28 (0%)	0	0/14 (0%)	0	2/14 (14.3%)	2	0/27 (0%)	0
Cardiac disorders
Atrial Fibrillation	0/28 (0%)	0	2/14 (14.3%)	2	0/14 (0%)	0	1/27 (3.7%)	1
Palpitations	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Ear and labyrinth disorders
Tinnitus	0/28 (0%)	0	2/14 (14.3%)	2	0/14 (0%)	0	0/27 (0%)	0
Vertigo	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	1/27 (3.7%)	1
Endocrine disorders
Adrenal Insufficiency	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Goitre	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Eye disorders
Amaurosis Fugax	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Cataract	1/28 (3.6%)	1	0/14 (0%)	0	2/14 (14.3%)	4	1/27 (3.7%)	1
Cataract Subcapsular	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Conjunctivitis Allergic	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Dry Eye	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Eye Irritation	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Keratitis	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Refraction Disorder	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Vision Blurred	0/28 (0%)	0	2/14 (14.3%)	2	0/14 (0%)	0	0/27 (0%)	0
Vitreous Floaters	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Gastrointestinal disorders
Abdominal Pain	1/28 (3.6%)	1	0/14 (0%)	0	0/14 (0%)	0	2/27 (7.4%)	3
Abdominal Pain Upper	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Constipation	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Dental Caries	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	1/27 (3.7%)	1
Diarrhoea	2/28 (7.1%)	4	2/14 (14.3%)	2	3/14 (21.4%)	3	3/27 (11.1%)	4
Dysphagia	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Inguinal Hernia	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Large Intestine Polyp	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Nausea	2/28 (7.1%)	2	0/14 (0%)	0	0/14 (0%)	0	0/27 (0%)	0
Vomiting	3/28 (10.7%)	3	0/14 (0%)	0	0/14 (0%)	0	1/27 (3.7%)	1
General disorders
Fatigue	2/28 (7.1%)	2	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Injection Site Erythema	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	9	0/27 (0%)	0
Injection Site Pain	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Injection Site Pruritus	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	1/27 (3.7%)	1
Injection Site Rash	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	1/27 (3.7%)	1
Injection Site Reaction	0/28 (0%)	0	0/14 (0%)	0	4/14 (28.6%)	8	1/27 (3.7%)	1
Injection Site Swelling	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Malaise	1/28 (3.6%)	1	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Oedema Peripheral	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	2/27 (7.4%)	2
Vessel Puncture Site Phlebitis	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Infections and infestations
Cellulitis	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Cystitis	2/28 (7.1%)	3	0/14 (0%)	0	0/14 (0%)	0	1/27 (3.7%)	1
Gastroenteritis	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Herpes Simplex	2/28 (7.1%)	4	0/14 (0%)	0	0/14 (0%)	0	1/27 (3.7%)	1
Herpes Zoster	1/28 (3.6%)	1	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Influenza	1/28 (3.6%)	1	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Localised Infection	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Nasopharyngitis	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	1/27 (3.7%)	1
Oral Candidiasis	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Oral Herpes	1/28 (3.6%)	1	0/14 (0%)	0	0/14 (0%)	0	2/27 (7.4%)	2
Respiratory Tract Infection	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Rhinitis	1/28 (3.6%)	1	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Sinusitis	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Tooth Infection	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Urinary Tract Infection Bacterial	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	1/27 (3.7%)	1
Viral Upper Respiratory Tract Infection	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Injury, poisoning and procedural complications
Arthropod Bite	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Contusion	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	1/27 (3.7%)	2
Fall	0/28 (0%)	0	2/14 (14.3%)	2	0/14 (0%)	0	4/27 (14.8%)	4
Post-Traumatic Pain	0/28 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	2/27 (7.4%)	2
Skin Laceration	0/28 (0%)	0	1/14 (7.1%)	1	1/14 (7.1%)	1	1/27 (3.7%)	2
Spinal Compression Fracture	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Stress Fracture	2/28 (7.1%)	2	0/14 (0%)	0	0/14 (0%)	0	0/27 (0%)	0
Vaccination Complication	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Investigations
Creatinine Renal Clearance Decreased	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
International Normalised Ratio Increased	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Weight Increased	0/28 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	2/27 (7.4%)	2
Metabolism and nutrition disorders
Decreased Appetite	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	1/27 (3.7%)	1
Glucose Tolerance Impaired	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Hypercholesterolaemia	2/28 (7.1%)	2	0/14 (0%)	0	0/14 (0%)	0	0/27 (0%)	0
Hyperlipidaemia	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	1/27 (3.7%)	1
Hypokalaemia	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Steroid Diabetes	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	2/28 (7.1%)	2	0/14 (0%)	0	4/14 (28.6%)	4	2/27 (7.4%)	3
Arthropathy	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Back Pain	0/28 (0%)	0	1/14 (7.1%)	1	1/14 (7.1%)	1	1/27 (3.7%)	1
Bursitis	1/28 (3.6%)	1	1/14 (7.1%)	1	2/14 (14.3%)	3	1/27 (3.7%)	1
Chondrocalcinosis	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Intervertebral Disc Protrusion	1/28 (3.6%)	1	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Muscle Spasms	1/28 (3.6%)	1	0/14 (0%)	0	1/14 (7.1%)	1	1/27 (3.7%)	1
Musculoskeletal Chest Pain	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	1/27 (3.7%)	1
Myopathy	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	1/27 (3.7%)	1
Osteoarthritis	2/28 (7.1%)	2	0/14 (0%)	0	1/14 (7.1%)	2	0/27 (0%)	0
Osteopenia	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Pain In Extremity	2/28 (7.1%)	2	0/14 (0%)	0	0/14 (0%)	0	0/27 (0%)	0
Pain In Jaw	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	1/27 (3.7%)	1
Rotator Cuff Syndrome	1/28 (3.6%)	1	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Spinal Osteoarthritis	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Nervous system disorders
Burning Sensation	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Cognitive Disorder	1/28 (3.6%)	1	3/14 (21.4%)	3	1/14 (7.1%)	1	1/27 (3.7%)	1
Decreased Vibratory Sense	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Dizziness	0/28 (0%)	0	1/14 (7.1%)	1	1/14 (7.1%)	1	0/27 (0%)	0
Headache	5/28 (17.9%)	6	2/14 (14.3%)	7	1/14 (7.1%)	1	4/27 (14.8%)	5
Memory Impairment	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Syncope	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Psychiatric disorders
Depressed Mood	0/28 (0%)	0	2/14 (14.3%)	3	0/14 (0%)	0	0/27 (0%)	0
Depression	5/28 (17.9%)	5	1/14 (7.1%)	1	0/14 (0%)	0	1/27 (3.7%)	1
Insomnia	3/28 (10.7%)	3	2/14 (14.3%)	2	2/14 (14.3%)	2	2/27 (7.4%)	2
Mania	2/28 (7.1%)	2	5/14 (35.7%)	5	1/14 (7.1%)	1	1/27 (3.7%)	2
Reproductive system and breast disorders
Uterine Polyp	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Respiratory, thoracic and mediastinal disorders
Allergic Cough	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Cough	3/28 (10.7%)	3	0/14 (0%)	0	0/14 (0%)	0	2/27 (7.4%)	2
Dyspnoea	0/28 (0%)	0	1/14 (7.1%)	1	1/14 (7.1%)	1	0/27 (0%)	0
Dyspnoea Exertional	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Emphysema	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Oropharyngeal Pain	0/28 (0%)	0	1/14 (7.1%)	1	2/14 (14.3%)	3	0/27 (0%)	0
Sleep Apnoea Syndrome	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	2/28 (7.1%)	2	0/14 (0%)	0	2/14 (14.3%)	2	0/27 (0%)	0
Ecchymosis	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Eczema	0/28 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	2/27 (7.4%)	2
Erythema	2/28 (7.1%)	2	0/14 (0%)	0	0/14 (0%)	0	1/27 (3.7%)	1
Hirsutism	2/28 (7.1%)	2	2/14 (14.3%)	2	1/14 (7.1%)	1	0/27 (0%)	0
Hyperhidrosis	1/28 (3.6%)	1	1/14 (7.1%)	1	1/14 (7.1%)	1	0/27 (0%)	0
Hypertrichosis	0/28 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	2/27 (7.4%)	2
Miliaria	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Night Sweats	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Photosensitivity Reaction	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Skin Atrophy	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Skin Discharge	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Skin Exfoliation	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Skin Fragility	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0
Skin Striae	0/28 (0%)	0	1/14 (7.1%)	1	2/14 (14.3%)	2	1/27 (3.7%)	1
Skin Ulcer	1/28 (3.6%)	1	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Urticaria	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	1/27 (3.7%)	1
Vascular disorders
Hypertension	0/28 (0%)	0	1/14 (7.1%)	1	1/14 (7.1%)	1	3/27 (11.1%)	3
Hypertensive Emergency	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	2	0/27 (0%)	0
Peripheral Arterial Occlusive Disease	0/28 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/27 (0%)	0
Phlebitis	0/28 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/27 (0%)	0

Limitations/Caveats

Study was prematurely discontinued due to protracted enrolment exacerbated by Covid-19 pandemic situation and not due to any safety issues from administration of sarilumab.

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Certain Agreements

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

The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.