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Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03600805
Recruitment Status : Terminated (Protracted recruitment timeline exacerbated by COVID-19 pandemic)
First Posted : July 26, 2018
Results First Posted : January 14, 2022
Last Update Posted : March 28, 2022
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Giant Cell Arteritis
Interventions Drug: Sarilumab SAR153191
Drug: Sarilumab matching placebo
Drug: Prednisone
Drug: Prednisone matching placebo
Enrollment 83
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 Details 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
Hide 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 [1] 10 6 7 13
Completed 9 6 6 8
Not Completed 19 8 8 19
Reason Not Completed
Adverse Event             2             1             1             7
Lack of Efficacy             2             1             0             0
Withdrawal by Subject             1             0             0             1
Other unspecified             14             6             7             11
[1]
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 Total Title
Hide 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. [Not Specified]
Overall Number of Baseline Participants 28 14 14 27 83
Hide Baseline Analysis Population Description
Analysis was performed on randomized population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 14 participants 14 participants 27 participants 83 participants
71.4  (7.7) 69.5  (5.4) 67.1  (7.9) 73.4  (8.6) 71.0  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 14 participants 14 participants 27 participants 83 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 14 participants 14 participants 27 participants 83 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
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
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   7.1%
0
   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
   0.0%
0
   0.0%
Unknown or Not Reported
5
  17.9%
1
   7.1%
2
  14.3%
2
   7.4%
10
  12.0%
1.Primary Outcome
Title Percentage of Participants Who Achieved Sustained Disease Remission at Week 52
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 10 6 7 13
Measure Type: Number
Unit of Measure: percentage of participants
30.0 0 42.9 46.2
2.Primary Outcome
Title Percentage of Participants Who Achieved Sustained Disease Remission at Week 24
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 28 14 14 27
Measure Type: Number
Unit of Measure: percentage of participants
39.3 7.1 42.9 48.1
3.Secondary Outcome
Title Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 10 6 7 13
Measure Type: Count of Participants
Unit of Measure: Participants
7
  70.0%
3
  50.0%
4
  57.1%
7
  53.8%
4.Secondary Outcome
Title Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 28 14 14 27
Measure Type: Count of Participants
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 10 6 7 13
Measure Type: Count of Participants
Unit of Measure: Participants
7
  70.0%
3
  50.0%
4
  57.1%
7
  53.8%
6.Secondary Outcome
Title Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 28 14 14 27
Measure Type: Count of Participants
Unit of Measure: Participants
21
  75.0%
7
  50.0%
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 10 6 7 13
Measure Type: Count of Participants
Unit of Measure: Participants
6
  60.0%
3
  50.0%
5
  71.4%
8
  61.5%
8.Secondary Outcome
Title Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 28 14 14 27
Measure Type: Count of Participants
Unit of Measure: Participants
20
  71.4%
4
  28.6%
11
  78.6%
17
  63.0%
9.Secondary Outcome
Title Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 10 6 7 13
Measure Type: Count of Participants
Unit of Measure: Participants
6
  60.0%
2
  33.3%
3
  42.9%
6
  46.2%
10.Secondary Outcome
Title Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 28 14 14 27
Measure Type: Count of Participants
Unit of Measure: Participants
18
  64.3%
5
  35.7%
7
  50.0%
13
  48.1%
11.Secondary Outcome
Title Total Cumulative Corticosteroid (Including Prednisone) Dose
Hide 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
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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
Hide 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 Number of Participants Analyzed 28 14 14 27
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
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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
Hide 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 Number of Participants Analyzed 28 14 14 27
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(141.000 to NA)
170.00 [2] 
(85.000 to NA)
NA [3] 
(58.000 to NA)
NA [3] 
(77.000 to NA)
[1]
Median and upper limit of 95% confidence interval (CI) was not estimable due to very low number of participants with the events.
[2]
Upper limit of 95% CI was not estimable due to very low number of participants with the events.
[3]
Median and upper limit of 95% CI was not estimable due to very low number of participants with the events.
13.Secondary Outcome
Title Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population
Hide 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
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Hide 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
Hide 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 Number of Participants Analyzed 28 14 14 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
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Hide 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
Hide 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 Number of Participants Analyzed 10 6 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Hide 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)
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Hide 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
Hide 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 Number of Participants Analyzed 28 14 14 27
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
24
  85.7%
14
 100.0%
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
Hide 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
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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
Hide 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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter
Baseline Number Analyzed 14 participants 26 participants
0.00  (0.00) 0.00  (0.00)
Week 2 Number Analyzed 14 participants 25 participants
2099.29  (3114.92) 5400.82  (4124.63)
Week 4 Number Analyzed 13 participants 25 participants
4644.71  (5994.17) 11640.98  (8574.00)
Week 12 Number Analyzed 13 participants 20 participants
8371.33  (7608.42) 27586.00  (17496.07)
Week 16 Number Analyzed 12 participants 17 participants
8111.08  (5962.56) 28911.88  (20821.06)
Week 24 Number Analyzed 12 participants 19 participants
12926.67  (9509.92) 35451.74  (23953.29)
Week 52 Number Analyzed 6 participants 9 participants
19780.00  (21829.95) 46766.67  (21172.15)
17.Secondary Outcome
Title Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24
Hide Description Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay.
Time Frame post-dose at Week 24
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Hide 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
Hide 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.
Overall Number of Participants Analyzed 11 13
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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)
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Hide 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
Hide 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 Number of Participants Analyzed 26 13 14 24
Measure Type: Number
Unit of Measure: percentage of participants
Treatment-boosted ADA positive participants 0 0 0 0
Treatment-emergent ADA positive participants 3.8 0 7.1 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 28 14 14 27
Mean (Standard Deviation)
Unit of Measure: millimeters per hour
Baseline Number Analyzed 28 participants 13 participants 14 participants 27 participants
29.3  (27.3) 21.9  (16.2) 24.9  (22.0) 18.2  (16.8)
Week 2 Number Analyzed 27 participants 11 participants 14 participants 24 participants
-1.1  (17.9) 0.7  (11.4) -10.4  (16.4) -8.8  (12.4)
Week 4 Number Analyzed 25 participants 10 participants 13 participants 25 participants
-4.2  (21.4) 5.2  (19.7) -13.3  (22.6) -9.4  (15.2)
Week 8 Number Analyzed 24 participants 13 participants 12 participants 24 participants
-2.0  (22.7) 10.2  (12.6) -11.9  (18.9) -8.7  (16.1)
Week 12 Number Analyzed 21 participants 13 participants 12 participants 23 participants
-1.5  (24.9) 9.8  (13.3) -14.7  (19.2) -11.0  (14.1)
Week 16 Number Analyzed 22 participants 12 participants 13 participants 19 participants
-4.1  (22.7) 9.8  (16.5) -13.5  (18.1) -10.4  (12.7)
Week 20 Number Analyzed 21 participants 11 participants 14 participants 20 participants
-6.6  (23.7) 8.8  (14.6) -18.2  (23.5) -10.9  (12.2)
Week 24 Number Analyzed 21 participants 10 participants 14 participants 22 participants
-4.2  (22.0) 13.9  (16.1) -16.4  (25.6) -9.3  (11.5)
Week 32 Number Analyzed 22 participants 10 participants 9 participants 17 participants
-7.0  (21.3) 6.6  (16.2) -9.4  (18.0) -7.9  (10.6)
Week 40 Number Analyzed 19 participants 8 participants 8 participants 14 participants
-1.5  (22.3) 4.0  (18.1) -10.1  (25.2) -7.9  (8.6)
Week 52 Number Analyzed 13 participants 7 participants 6 participants 10 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 28 14 14 27
Mean (Standard Deviation)
Unit of Measure: milligrams per liter
Baseline Number Analyzed 28 participants 14 participants 14 participants 27 participants
10.9  (20.0) 9.7  (18.3) 10.1  (12.4) 3.7  (6.2)
Week 2 Number Analyzed 26 participants 11 participants 14 participants 26 participants
0.4  (21.0) -1.0  (21.2) -3.5  (11.2) -2.0  (7.6)
Week 4 Number Analyzed 25 participants 11 participants 13 participants 25 participants
-3.6  (19.3) -2.2  (21.8) -2.6  (18.7) -1.9  (8.3)
Week 8 Number Analyzed 23 participants 12 participants 12 participants 21 participants
-4.0  (19.5) -0.9  (17.0) -3.5  (11.7) -1.7  (5.5)
Week 12 Number Analyzed 21 participants 12 participants 13 participants 21 participants
-4.4  (22.0) 4.4  (18.9) -3.3  (17.9) -1.1  (8.4)
Week 16 Number Analyzed 22 participants 11 participants 13 participants 16 participants
-4.5  (20.7) 5.0  (23.9) -5.0  (14.1) -1.8  (3.0)
Week 20 Number Analyzed 21 participants 9 participants 13 participants 18 participants
-4.5  (21.1) 0.6  (17.6) -4.9  (13.6) -1.6  (2.9)
Week 24 Number Analyzed 21 participants 7 participants 12 participants 18 participants
-4.1  (19.5) 0.3  (32.6) -3.1  (18.3) -1.0  (4.5)
Week 32 Number Analyzed 21 participants 7 participants 7 participants 14 participants
-5.2  (19.6) 1.1  (35.4) -5.8  (17.1) -0.4  (6.5)
Week 40 Number Analyzed 16 participants 6 participants 7 participants 10 participants
-1.9  (22.3) -9.2  (27.0) -2.2  (11.1) -2.8  (3.5)
Week 52 Number Analyzed 7 participants 4 participants 4 participants 5 participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 28 14 14 27
Mean (Standard Deviation)
Unit of Measure: nanograms per Liter
Baseline Number Analyzed 25 participants 12 participants 13 participants 23 participants
10.91  (12.85) 8.74  (5.78) 11.03  (15.33) 7.71  (7.30)
Week 2 Number Analyzed 23 participants 8 participants 13 participants 22 participants
2.90  (17.46) 3.47  (10.30) 31.74  (31.13) 117.33  (245.28)
Week 12 Number Analyzed 18 participants 7 participants 11 participants 17 participants
-0.88  (12.60) 5.56  (8.08) 52.38  (47.46) 81.82  (50.85)
Week 24 Number Analyzed 20 participants 4 participants 11 participants 15 participants
-1.03  (7.15) 5.57  (19.81) 53.60  (53.71) 69.20  (46.89)
Week 52 Number Analyzed 7 participants 3 participants 3 participants 6 participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 28 14 14 27
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter
Baseline Number Analyzed 27 participants 14 participants 13 participants 27 participants
136.63  (260.57) 54.80  (18.48) 50.05  (17.84) 61.37  (72.43)
Week 2 Number Analyzed 0 participants 0 participants 13 participants 26 participants
212.19  (51.99) 224.87  (107.43)
Week 12 Number Analyzed 1 participants 0 participants 12 participants 21 participants
17.67 336.30  (107.49) 427.40  (124.97)
Week 24 Number Analyzed 3 participants 0 participants 11 participants 18 participants
-12.72  (3.97) 311.88  (184.32) 456.09  (118.07)
Week 52 Number Analyzed 8 participants 2 participants 4 participants 7 participants
-131.47  (356.65) -9.69  (11.14) 377.23  (84.99) 471.16  (182.72)
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      1/14 (7.14%)      0/14 (0.00%)      2/27 (7.41%)    
Hide 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 (7.14%)      3/14 (21.43%)      2/14 (14.29%)      7/27 (25.93%)    
Blood and lymphatic system disorders         
Neutropenia  1  0/28 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 2/27 (7.41%)  2
Eye disorders         
Blindness Unilateral  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Retinal Artery Occlusion  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Gastrointestinal disorders         
Colitis Ulcerative  1  1/28 (3.57%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/27 (0.00%)  0
Hiatus Hernia  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Infections and infestations         
Covid-19  1  0/28 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/27 (3.70%)  1
Cellulitis  1  0/28 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/27 (3.70%)  1
Lower Respiratory Tract Infection  1  1/28 (3.57%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/27 (0.00%)  0
Pyelonephritis  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Septic Shock  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Urosepsis  1  0/28 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/27 (3.70%)  1
Injury, poisoning and procedural complications         
Femur Fracture  1  0/28 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/27 (3.70%)  1
Nervous system disorders         
Cerebral Amyloid Angiopathy  1  0/28 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders         
Acute Respiratory Failure  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Vascular disorders         
Aortic Dissection  1  0/28 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/27 (3.70%)  1
Deep Vein Thrombosis  1  1/28 (3.57%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/27 (0.00%)  0
Peripheral Vascular Disorder  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
1
Term from vocabulary, MedDRA23.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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 (78.57%)      13/14 (92.86%)      13/14 (92.86%)      20/27 (74.07%)    
Blood and lymphatic system disorders         
Increased Tendency To Bruise  1  5/28 (17.86%)  5 3/14 (21.43%)  3 3/14 (21.43%)  3 3/27 (11.11%)  4
Neutropenia  1  0/28 (0.00%)  0 0/14 (0.00%)  0 2/14 (14.29%)  2 0/27 (0.00%)  0
Cardiac disorders         
Atrial Fibrillation  1  0/28 (0.00%)  0 2/14 (14.29%)  2 0/14 (0.00%)  0 1/27 (3.70%)  1
Palpitations  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Ear and labyrinth disorders         
Tinnitus  1  0/28 (0.00%)  0 2/14 (14.29%)  2 0/14 (0.00%)  0 0/27 (0.00%)  0
Vertigo  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 1/27 (3.70%)  1
Endocrine disorders         
Adrenal Insufficiency  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Goitre  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Eye disorders         
Amaurosis Fugax  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Cataract  1  1/28 (3.57%)  1 0/14 (0.00%)  0 2/14 (14.29%)  4 1/27 (3.70%)  1
Cataract Subcapsular  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Conjunctivitis Allergic  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Dry Eye  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Eye Irritation  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Keratitis  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Refraction Disorder  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Vision Blurred  1  0/28 (0.00%)  0 2/14 (14.29%)  2 0/14 (0.00%)  0 0/27 (0.00%)  0
Vitreous Floaters  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Gastrointestinal disorders         
Abdominal Pain  1  1/28 (3.57%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 2/27 (7.41%)  3
Abdominal Pain Upper  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Constipation  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Dental Caries  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 1/27 (3.70%)  1
Diarrhoea  1  2/28 (7.14%)  4 2/14 (14.29%)  2 3/14 (21.43%)  3 3/27 (11.11%)  4
Dysphagia  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Inguinal Hernia  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Large Intestine Polyp  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Nausea  1  2/28 (7.14%)  2 0/14 (0.00%)  0 0/14 (0.00%)  0 0/27 (0.00%)  0
Vomiting  1  3/28 (10.71%)  3 0/14 (0.00%)  0 0/14 (0.00%)  0 1/27 (3.70%)  1
General disorders         
Fatigue  1  2/28 (7.14%)  2 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Injection Site Erythema  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  9 0/27 (0.00%)  0
Injection Site Pain  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Injection Site Pruritus  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 1/27 (3.70%)  1
Injection Site Rash  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 1/27 (3.70%)  1
Injection Site Reaction  1  0/28 (0.00%)  0 0/14 (0.00%)  0 4/14 (28.57%)  8 1/27 (3.70%)  1
Injection Site Swelling  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Malaise  1  1/28 (3.57%)  1 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Oedema Peripheral  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 2/27 (7.41%)  2
Vessel Puncture Site Phlebitis  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Infections and infestations         
Cellulitis  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Cystitis  1  2/28 (7.14%)  3 0/14 (0.00%)  0 0/14 (0.00%)  0 1/27 (3.70%)  1
Gastroenteritis  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Herpes Simplex  1  2/28 (7.14%)  4 0/14 (0.00%)  0 0/14 (0.00%)  0 1/27 (3.70%)  1
Herpes Zoster  1  1/28 (3.57%)  1 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Influenza  1  1/28 (3.57%)  1 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Localised Infection  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Nasopharyngitis  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 1/27 (3.70%)  1
Oral Candidiasis  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Oral Herpes  1  1/28 (3.57%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 2/27 (7.41%)  2
Respiratory Tract Infection  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Rhinitis  1  1/28 (3.57%)  1 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Sinusitis  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Tooth Infection  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Urinary Tract Infection Bacterial  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 1/27 (3.70%)  1
Viral Upper Respiratory Tract Infection  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Injury, poisoning and procedural complications         
Arthropod Bite  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Contusion  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 1/27 (3.70%)  2
Fall  1  0/28 (0.00%)  0 2/14 (14.29%)  2 0/14 (0.00%)  0 4/27 (14.81%)  4
Post-Traumatic Pain  1  0/28 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 2/27 (7.41%)  2
Skin Laceration  1  0/28 (0.00%)  0 1/14 (7.14%)  1 1/14 (7.14%)  1 1/27 (3.70%)  2
Spinal Compression Fracture  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Stress Fracture  1  2/28 (7.14%)  2 0/14 (0.00%)  0 0/14 (0.00%)  0 0/27 (0.00%)  0
Vaccination Complication  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Investigations         
Creatinine Renal Clearance Decreased  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
International Normalised Ratio Increased  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Weight Increased  1  0/28 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 2/27 (7.41%)  2
Metabolism and nutrition disorders         
Decreased Appetite  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 1/27 (3.70%)  1
Glucose Tolerance Impaired  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Hypercholesterolaemia  1  2/28 (7.14%)  2 0/14 (0.00%)  0 0/14 (0.00%)  0 0/27 (0.00%)  0
Hyperlipidaemia  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 1/27 (3.70%)  1
Hypokalaemia  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Steroid Diabetes  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  2/28 (7.14%)  2 0/14 (0.00%)  0 4/14 (28.57%)  4 2/27 (7.41%)  3
Arthropathy  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Back Pain  1  0/28 (0.00%)  0 1/14 (7.14%)  1 1/14 (7.14%)  1 1/27 (3.70%)  1
Bursitis  1  1/28 (3.57%)  1 1/14 (7.14%)  1 2/14 (14.29%)  3 1/27 (3.70%)  1
Chondrocalcinosis  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Intervertebral Disc Protrusion  1  1/28 (3.57%)  1 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Muscle Spasms  1  1/28 (3.57%)  1 0/14 (0.00%)  0 1/14 (7.14%)  1 1/27 (3.70%)  1
Musculoskeletal Chest Pain  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 1/27 (3.70%)  1
Myopathy  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 1/27 (3.70%)  1
Osteoarthritis  1  2/28 (7.14%)  2 0/14 (0.00%)  0 1/14 (7.14%)  2 0/27 (0.00%)  0
Osteopenia  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Pain In Extremity  1  2/28 (7.14%)  2 0/14 (0.00%)  0 0/14 (0.00%)  0 0/27 (0.00%)  0
Pain In Jaw  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 1/27 (3.70%)  1
Rotator Cuff Syndrome  1  1/28 (3.57%)  1 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Spinal Osteoarthritis  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Nervous system disorders         
Burning Sensation  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Cognitive Disorder  1  1/28 (3.57%)  1 3/14 (21.43%)  3 1/14 (7.14%)  1 1/27 (3.70%)  1
Decreased Vibratory Sense  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Dizziness  1  0/28 (0.00%)  0 1/14 (7.14%)  1 1/14 (7.14%)  1 0/27 (0.00%)  0
Headache  1  5/28 (17.86%)  6 2/14 (14.29%)  7 1/14 (7.14%)  1 4/27 (14.81%)  5
Memory Impairment  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Syncope  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Psychiatric disorders         
Depressed Mood  1  0/28 (0.00%)  0 2/14 (14.29%)  3 0/14 (0.00%)  0 0/27 (0.00%)  0
Depression  1  5/28 (17.86%)  5 1/14 (7.14%)  1 0/14 (0.00%)  0 1/27 (3.70%)  1
Insomnia  1  3/28 (10.71%)  3 2/14 (14.29%)  2 2/14 (14.29%)  2 2/27 (7.41%)  2
Mania  1  2/28 (7.14%)  2 5/14 (35.71%)  5 1/14 (7.14%)  1 1/27 (3.70%)  2
Reproductive system and breast disorders         
Uterine Polyp  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Allergic Cough  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Cough  1  3/28 (10.71%)  3 0/14 (0.00%)  0 0/14 (0.00%)  0 2/27 (7.41%)  2
Dyspnoea  1  0/28 (0.00%)  0 1/14 (7.14%)  1 1/14 (7.14%)  1 0/27 (0.00%)  0
Dyspnoea Exertional  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Emphysema  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Oropharyngeal Pain  1  0/28 (0.00%)  0 1/14 (7.14%)  1 2/14 (14.29%)  3 0/27 (0.00%)  0
Sleep Apnoea Syndrome  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Skin and subcutaneous tissue disorders         
Alopecia  1  2/28 (7.14%)  2 0/14 (0.00%)  0 2/14 (14.29%)  2 0/27 (0.00%)  0
Ecchymosis  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Eczema  1  0/28 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 2/27 (7.41%)  2
Erythema  1  2/28 (7.14%)  2 0/14 (0.00%)  0 0/14 (0.00%)  0 1/27 (3.70%)  1
Hirsutism  1  2/28 (7.14%)  2 2/14 (14.29%)  2 1/14 (7.14%)  1 0/27 (0.00%)  0
Hyperhidrosis  1  1/28 (3.57%)  1 1/14 (7.14%)  1 1/14 (7.14%)  1 0/27 (0.00%)  0
Hypertrichosis  1  0/28 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 2/27 (7.41%)  2
Miliaria  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Night Sweats  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Photosensitivity Reaction  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Skin Atrophy  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Skin Discharge  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Skin Exfoliation  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Skin Fragility  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
Skin Striae  1  0/28 (0.00%)  0 1/14 (7.14%)  1 2/14 (14.29%)  2 1/27 (3.70%)  1
Skin Ulcer  1  1/28 (3.57%)  1 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Urticaria  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 1/27 (3.70%)  1
Vascular disorders         
Hypertension  1  0/28 (0.00%)  0 1/14 (7.14%)  1 1/14 (7.14%)  1 3/27 (11.11%)  3
Hypertensive Emergency  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  2 0/27 (0.00%)  0
Peripheral Arterial Occlusive Disease  1  0/28 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/27 (0.00%)  0
Phlebitis  1  0/28 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/27 (0.00%)  0
1
Term from vocabulary, MedDRA23.1
Indicates events were collected by systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi aventis recherche & développement
Phone: 800-633-1610 ext 6#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03600805    
Other Study ID Numbers: EFC15068
2017-002988-18 ( EudraCT Number )
U1111-1200-2184 ( Other Identifier: UTN )
First Submitted: July 17, 2018
First Posted: July 26, 2018
Results First Submitted: November 18, 2021
Results First Posted: January 14, 2022
Last Update Posted: March 28, 2022