Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

• ClinicalTrials.gov Identifier: NCT03600805
• Recruitment Status: Terminated
• First Posted: July 26, 2018
• Results First Posted: January 14, 2022
• Last Update Posted: March 28, 2022
• Sponsor: Sanofi
• 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

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 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
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).

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.	[Not Specified]
Overall Number of Baseline Participants		28	14	14	27	83
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%

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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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)
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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)

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 (%)		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%)
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
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

Limitations and 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.

More Information

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

• Name/Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement
• Phone: 800-633-1610 ext 6#
• EMail: Contact-US@sanofi.com

• 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