Trial Outcomes & Findings for Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH) (NCT NCT02332590)

NCT ID: NCT02332590

Last Updated: 2022-03-28

Results Overview

DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR and RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Least square (LS) mean and standard error (SE) at Week 24 were obtained using Mixed-effect model with repeated measures (MMRM) approach.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 369 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2022-03-28

Participant Flow

The study was conducted at 86 centers in 15 countries. A total of 540 participants were involved in the study from 28 January 2015 to 29-December-2020, of whom 369 participants were randomized and 171 were screen failures. Screen failures were mainly due to exclusion criteria met and inclusion criteria not met.

Participants were randomized in 1:1 ratio (Adalimumab 40 milligrams (mg) every 2 weeks [q2w]: Sarilumab 200 mg q2w) and treated for 24 weeks in double-blind (DB) period of the study. Out of 321 participants who completed DB period, 320 participants entered the open label extension (OLE) period of the study.

Participant milestones

Measure	Adalimumab 40 mg/Sarilumab 200 mg Adalimumab 40 mg subcutaneous (SC) injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (less than \[\<\] 20% improvement from baseline in tender joint count \[TJC\] and swollen joint count \[SJC\] for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period (up to 24 Weeks) STARTED	185	184
DB Period (up to 24 Weeks) Treated	184	184
DB Period (up to 24 Weeks) COMPLETED	156	165
DB Period (up to 24 Weeks) NOT COMPLETED	29	19
OLE Period (Week 24 up to Week 300) STARTED	155	165
OLE Period (Week 24 up to Week 300) COMPLETED	108	120
OLE Period (Week 24 up to Week 300) NOT COMPLETED	47	45

Reasons for withdrawal

Measure	Adalimumab 40 mg/Sarilumab 200 mg Adalimumab 40 mg subcutaneous (SC) injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (less than \[\<\] 20% improvement from baseline in tender joint count \[TJC\] and swollen joint count \[SJC\] for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period (up to 24 Weeks) Adverse Event	15	11
DB Period (up to 24 Weeks) Lack of Efficacy	4	2
DB Period (up to 24 Weeks) Poor compliance to protocol	3	1
DB Period (up to 24 Weeks) Randomized but not treated	1	0
DB Period (up to 24 Weeks) Other than specified above	6	5
OLE Period (Week 24 up to Week 300) Adverse Event	20	23
OLE Period (Week 24 up to Week 300) Lack of Efficacy	2	6
OLE Period (Week 24 up to Week 300) Poor compliance to protocol	5	1
OLE Period (Week 24 up to Week 300) Other Unspecified	20	15

Baseline Characteristics

Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

Baseline characteristics by cohort

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=185 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Total n=369 Participants Total of all reporting groups
Age, Continuous	53.6 years STANDARD_DEVIATION 11.9 • n=5 Participants	50.9 years STANDARD_DEVIATION 12.6 • n=7 Participants	52.2 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants	157 Participants n=7 Participants	307 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	27 Participants n=7 Participants	62 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/White	164 Participants n=5 Participants	171 Participants n=7 Participants	335 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Oriental	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Other	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Disease Activity Score 28 based on erythrocyte sedimentation rate (DAS28-ESR)	6.76 units on a scale STANDARD_DEVIATION 0.83 • n=5 Participants	6.83 units on a scale STANDARD_DEVIATION 0.76 • n=7 Participants	6.80 units on a scale STANDARD_DEVIATION 0.80 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Intent-to-treat (ITT) population included all participants. Overall Number of Participants Analyzed = participants with DAS28-ESR assessment at both baseline and Week 24.

DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR and RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Least square (LS) mean and standard error (SE) at Week 24 were obtained using Mixed-effect model with repeated measures (MMRM) approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=163 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in Disease Activity Score for 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Week 24	-2.20 units on a scale Standard Error 0.106	-3.28 units on a scale Standard Error 0.105

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population.

DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Participants who discontinued treatment prior to Week 24 were analyzed as non-responders.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=185 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Percentage of Participants Achieving Clinical Remission Score (DAS28-ESR <2.6) at Week 24	7.0 percentage of participants	26.6 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population.

ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (C-reactive protein [CRP] level); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by Health Assessment Questionnaire - Disability Index [HAQ-DI], with scoring range of 0 [better physical function] - 3 [worst physical function]). ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. Participants were analyzed as non-responders from the time they discontinued treatment.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=185 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Percentage of Participants Achieving ACR50 Criteria at Week 24	29.7 percentage of participants	45.7 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population.

ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (CRP level); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better physical function] - 3 [worst physical function]). ACR70 was defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments. Participants were analyzed as non-responders from the time they discontinued treatment.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=185 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Percentage of Participants Achieving ACR70 Criteria at Week 24	11.9 percentage of participants	23.4 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT population.

ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (CRP level); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better physical function] - 3 [worst physical function]). ACR20 was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments. Participants were analyzed as non-responders from the time they discontinued treatment.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=185 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Percentage of Participants Achieving ACR20 Criteria at Week 24	58.4 percentage of participants	71.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with HAQ-DI assessment at both baseline and Week 24.

Physical function was assessed by HAQ-DI. It consisted of at least 2 or 3 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=158 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in HAQ-DI at Week 24	-0.43 units on a scale Standard Error 0.045	-0.61 units on a scale Standard Error 0.045

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with SF-36 PCS score assessment at both baseline and Week 24.

SF-36 is a generic 36-item questionnaire consisting of 8 sub-scales, measures health-related quality of life (HRQL) in the last 4 weeks covering 2 summary measures: PCS and mental component summary (MCS). PCS with 4 sub-scales: physical function, role limitations due to physical problems, pain, and general health perception; and MCS with 4 sub-scales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a sub-scale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same sub-scale give the sub-scale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Both PCS and MCS range from 0-100 with higher scores indicating better physical and mental health. LS mean and SE at Week 24 by MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=157 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=159 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in Short-Form-36 (SF-36) - Physical Component Summary (PCS) Score at Week 24	6.09 units on a scale Standard Error 0.555	8.74 units on a scale Standard Error 0.555

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with FACIT-F score assessment both at baseline and Week 24.

The FACIT-F is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0-4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A total score ranged from 0 to 52, where higher score corresponds to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 24 by MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=158 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24	8.41 units on a scale Standard Error 0.709	10.18 units on a scale Standard Error 0.701

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with SF-36 - mental health component summary score assessment both at baseline and Week 24.

SF-36 is a generic 36-item questionnaire consisting of 8 sub-scales, measures HRQL in the last 4 weeks covering 2 summary measures: PCS and MCS. PCS with 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception; and MCS with 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same sub-scale give the sub-scale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Both PCS and MCS range from 0-100 with higher scores indicating better physical and mental health. LS mean and SE at Week 24 by MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=157 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=159 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in SF-36 - Mental Health Component Summary Score at Week 24	6.83 units on a scale Standard Error 0.774	7.86 units on a scale Standard Error 0.773

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with DAS28-CRP score assessment at both baseline and Week 24.

DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28-CRP score provides a number indicating the current disease activity of the RA. DAS28-CRP total score ranges from 2-10. A DAS28-CRP score above 5.1 means high disease activity, whereas a DAS28-CRP score below 3.2 indicates low disease activity and a DAS28-CRP score below 2.6 means disease remission. LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=156 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=163 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP Score) at Week 24	-1.97 units on a scale Standard Error 0.094	-2.86 units on a scale Standard Error 0.093

SECONDARY outcome

Timeframe: Week 24

Population: ITT population.

DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by hs-CRP in mg/L. The DAS28-CRP score provides a number indicating the current disease activity of the RA. DAS28-CRP total score ranges from 2-10. A DAS28-CRP score above 5.1 means high disease activity, whereas a DAS28-CRP score below 3.2 indicates low disease activity and a DAS28-CRP score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=185 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP <2.6) at Week 24	13.5 percentage of participants	34.2 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population.

DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=185 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Percentage of Participants Achieving Low Disease Activity (DAS28-ESR < 3.2) at Week 24	14.1 percentage of participants	42.9 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT population.

CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global assessment of disease activity (in cm), and physician's global assessment of disease activity (in cm). Total score ranges from 0 to 76 with a lower score indicating less disease activity. Participants were analyzed as non-responders from the time they discontinued treatment.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=185 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Remission (CDAI ≤2.8) at Week 24	2.7 percentage of participants	7.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with CDAI assessment both at baseline and Week 24.

CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global assessment of disease activity (in cm), and physician's global assessment of disease activity (VAS in cm). Total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. LS means and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=158 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in CDAI at Week 24	-25.20 units on a scale Standard Error 0.842	-28.94 units on a scale Standard Error 0.834

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with EQ-5D-3L score assessment both at baseline and Week 24. Here, Number Analyzed = participants with available data for specified category for each arm, respectively.

EQ-5D-3L is a standardized, generic measure of health outcome. EQ-5D was designed for self-completion by participants. EQ-5D was specifically included to address concerns regarding the health economic impact of RA. EQ-5D-3L comprises of 5 questions on mobility, self-care, pain/discomfort, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems). The 5-dimensional 3-level systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-3L-VAS records the participant's self-rated health on a vertical VAS that allows the participants to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=156 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=164 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) Scores at Week 24 EQ-5D Single index utility score	0.26 units on a scale Standard Error 0.019	0.32 units on a scale Standard Error 0.019
DB Period: Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) Scores at Week 24 EQ-5D VAS	19.94 units on a scale Standard Error 1.720	24.22 units on a scale Standard Error 1.686

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with RAID assessment both at baseline and Week 24.

RAID is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well-being, quality of sleep, and coping. The RAID is calculated based on 7 numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10 that corresponds to the 7 domains. The values for each of these domains are weighed by participant assessment of relative importance and combined in a single score with a total score range of 0 (not affected, very good) to 10 (most affected). LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=157 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=161 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) at Week 24	-2.30 units on a scale Standard Error 0.168	-3.08 units on a scale Standard Error 0.168

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with WPS-RA values available: Individual items assessment both at baseline and Week 24.

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days missed in the last month by the participant was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=60 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=70 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to Arthritis	0.05 days Standard Error 0.611	-0.28 days Standard Error 0.547

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with WPS-RA values available: Individual items assessment both at baseline and Week 24.

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by >= 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=60 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=70 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to Arthritis	-3.50 days Standard Error 0.525	-3.74 days Standard Error 0.456

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT Population. Number of participants analyzed = participants with WPS-RA values available: Individual items assessment both at baseline and Week 24.

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=60 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=69 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in WPS-RA at Week 24: Arthritis Interference With Work Productivity	-2.510 units on a scale Standard Error 0.3470	-2.919 units on a scale Standard Error 0.3073

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with WPS-RA values available: Individual items assessment both at baseline and Week 24.

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=163 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=169 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to Arthritis	-4.22 days Standard Error 0.405	-5.49 days Standard Error 0.400

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with WPS-RA values available: Individual items assessment both at baseline and Week 24.

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by >= 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=163 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=169 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by >= 50% Due to Arthritis	-4.87 days Standard Error 0.451	-6.70 days Standard Error 0.445

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with WPS-RA values available: Individual items assessment both at baseline and Week 24.

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=163 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=169 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to Arthritis	-3.33 days Standard Error 0.376	-4.14 days Standard Error 0.371

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed =participants with WPS-RA values available: Individual items assessment both at baseline and Week 24.

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=163 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=168 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to Arthritis	-2.57 days Standard Error 0.401	-3.43 days Standard Error 0.398

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with WPS-RA values available: Individual items assessment both at baseline and Week 24.

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=163 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=168 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity	-2.605 units on a scale Standard Error 0.2110	-3.276 units on a scale Standard Error 0.2099

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with morning stiffness VAS assessment both at baseline and Week 24.

RA is associated with stiffness of joints, especially in the morning after prolonged stationery state. The degree of stiffness can be an indicator of disease severity. The severity of morning stiffness was assessed on a VAS scale from 0 mm (no problem) to 100 mm (major problem). LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=156 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in Morning Stiffness VAS at Week 24	-29.29 mm Standard Error 1.970	-35.08 mm Standard Error 1.947

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with TJC and SJC assessment both at baseline and Week 24.

ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). 68 joints were assessed for tenderness (TJC scoring 0-68) and 66 joints for swelling (SJC scoring 0-66). The 66 SJC evaluated the following joints: temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, interphalangeal of thumb, distal interphalangeal, proximal interphalangeal, knee, ankle mortise, ankle tarsus, metatarsophalangeal, interphalangeal of great toe, and proximal/distal interphalangeal of the toes. The TJC examined hip joints, in addition to the joints assessed for SJC. Increase in number of tender joints/swollen joints indicated severity. LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=158 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=166 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in Individual ACR Component - TJC and SJC at Week 24 TJC	-16.45 joints Standard Error 0.781	-18.23 joints Standard Error 0.772
DB Period: Change From Baseline in Individual ACR Component - TJC and SJC at Week 24 SJC	-12.20 joints Standard Error 0.450	-13.44 joints Standard Error 0.444

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with individual ACR components assessment both at baseline and Week 24. Here, Number Analyzed = participants with available data for specified category for each arm, respectively.

ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). Physician global VAS & participant global VAS was done on 100 mm horizontal anchored VAS, ranging from 0 "no arthritis activity" to 100 "maximal arthritis activity" and Pain VAS on 100 mm VAS, ranging from 0 "no pain" to 100 "worst pain". LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=158 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=166 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 24 Physician global VAS	-37.80 mm Standard Error 1.431	-45.33 mm Standard Error 1.414
DB Period: Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 24 Participant global VAS	-24.82 mm Standard Error 1.752	-33.30 mm Standard Error 1.731
DB Period: Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 24 Pain VAS	-27.41 mm Standard Error 1.802	-36.19 mm Standard Error 1.776

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with CRP assessment both at baseline and Week 24.

ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). An elevated CRP level is considered a non-specific "marker" for RA. A decrease indicates improvement. LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=156 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=164 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in Individual ACR Component - CRP Level at Week 24	-2.91 mg/L Standard Error 1.461	-17.01 mg/L Standard Error 1.431

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population. Number of participants analyzed = participants with ESR assessment both at baseline and Week 24.

ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). The ESR is a blood test that can reveal inflammatory activity. Inflammation can cause the cells to clump together. The farther the red blood cells have descended, the greater the inflammatory response. LS mean and SE at Week 24 were obtained using MMRM approach.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=163 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=166 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Change From Baseline in Individual ACR Component- ESR Level at Week 24	-12.74 mm/hr Standard Error 1.398	-32.11 mm/hr Standard Error 1.388

SECONDARY outcome

Timeframe: From Week 0 to Week 24

Population: Analysis was performed on safety population (DB period) which consisted of all randomized participants who received at least one dose of study medication analyzed according to the treatment they have actually received.

Adverse event (AE) was defined as any untoward medical occurrence in participant who received investigational medicinal product (IMP) and did not necessarily had to have causal relationship with treatment. All reported AEs are TEAEs developed/worsened during 'on treatment period' (time from first dose of study drug up to day before first dose of open-label treatment for participants who completed 24-week randomized//DB treatment). SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=184 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	117 Participants	118 Participants
DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	13 Participants	9 Participants

SECONDARY outcome

Timeframe: From end of Week 24 (Baseline of OLE Period) up to last dose in OLE + 6 weeks of follow up (i.e. up to Week 306)

Population: Analysis was performed on safety population (OLE period) which included all randomized participants who continued OLE period and received at least one dose of the study medication during OLE period, analyzed according to the treatment they have actually received.

AE was defined as any untoward medical occurrence in participant who received IMP and did not necessarily had to have causal relationship with treatment. All reported AEs are TEAEs developed/worsened during 'on treatment period' (from end of week 24 [Baseline of OLE Period] up to last dose in OLE period + 6 weeks [follow-up], regardless of unplanned intermittent discontinuations). SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=155 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
OLE Period: Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events TEAE	135 Participants	143 Participants
OLE Period: Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events SAE	31 Participants	25 Participants

SECONDARY outcome

Timeframe: From Week 0 to Week 24

Population: Analysis was performed on safety population (DB Period). Here, 'number analyzed' = participants with available data for each specified category.

Criteria for potentially clinically significant laboratory abnormalities included:

• Hemoglobin (Hb): less than or equal to (<=) 115 grams per liter (g/L) (Male), <= 95 g/L (Female); greater than or equal to (>=) 185 g/L (18.5 g/dL) (Male), >= 165 g/L (16.5 g/dL) (Female); Decrease From Baseline (DFB) = 20 g/L (2 g/dL).
• Hematocrit: <= 0.37 volume/volume (v/v) (Male); <= 0.32 v/v (F); >= 0.55 v/v (Male); >= 0.5 v/v (Female).
• Red Blood Cells (RBCs): >=6 Tera/ liter (L).
• Platelets: < 50 Giga/L, 50 - 100 Giga/L, >= 700 Giga/L.
• White blood cells (WBC): < 3.0 Giga/L (Non-Black); < 2.0 Giga/L (Black), >= 16.0 Giga/L.
• Neutrophils: < 1.0 Giga/L, < 1.5 Giga/L (Non-Black); < 1.0 Giga/L (Black).
• Lymphocytes: < 0.5 Giga/L, >= 0.5 Giga/L - lower limit of normal (LLN), > 4.0 Giga/L.
• Monocytes: > 0.7 Giga/L.
• Basophils: > 0.1 Giga/L.
• Eosinophils: > 0.5 Giga/L or > upper limit of normal (ULN) (if ULN >= 0.5 Giga/L).

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=184 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Hb:<=115 g/L, <=95 g/L	12 Participants	7 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Hb: >=185 g/L, >=165 g/L	0 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Hb: DFB >=20 g/L	5 Participants	5 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Hematocrit: <= 0.37 v/v; <=0.32 v/v	21 Participants	10 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Hematocrit: >=0.55 v/v; >=0.5 v/v	1 Participants	3 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters RBCs: >=6 Tera/L	0 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Platelets: < 50 Giga/L	0 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Platelets: 50 - 100 Giga/L	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Platelets: >= 700 Giga/L	1 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters WBC: < 3.0 Giga/L (Non-Black); < 2.0 Giga/L (Black)	1 Participants	32 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters WBC: >= 16.0 Giga/L	8 Participants	5 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Neutrophils: < 1.0 Giga/L	2 Participants	19 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Neutrophils: < 1.5 Giga/L (Non-Black); < 1.0 Giga/L (Black)	7 Participants	50 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Lymphocytes: < 0.5 Giga/L	2 Participants	2 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Lymphocytes: >= 0.5 Giga/L - LLN	8 Participants	21 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Lymphocytes: > 4.0 Giga/L	17 Participants	6 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Monocytes: > 0.7 Giga/L	46 Participants	38 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Basophils: > 0.1 Giga/L	53 Participants	37 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters Eosinophils: > 0.5 Giga/L or > ULN (if ULN >= 0.5 Giga/L)	4 Participants	9 Participants

SECONDARY outcome

Timeframe: From end of Week 24 (Baseline of OLE Period) up to Week 300

Population: Analysis was performed on safety population (OLE Period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria for potentially clinically significant laboratory abnormalities included:

• Hb: <=115 g/L (Male), <= 95 g/L (Female); >=185 g/L (18.5 g/dL) (Male), >= 165 g/L (16.5 g/dL) (Female); DFB >= 20 g/L (2 g/dL).
• Hematocrit: <= 0.37 v/v (Male); <= 0.32 v/v (Female); >= 0.55 v/v (Male); >= 0.5 v/v (Female).
• RBCs: >=6 Tera/ L.
• Platelets: < 50 Giga/L, >=50 - 100 Giga/L, >= 700 Giga/L.
• WBC: < 3.0 Giga/L (Non-Black); < 2.0 Giga/L (Black), >= 16.0 Giga/L.
• Neutrophils: < 1.0 Giga/L, < 1.5 Giga/L (Non-Black); < 1.0 Giga/L (Black).
• Lymphocytes: < 0.5 Giga/L, >= 0.5 Giga/L - LLN, > 4.0 Giga/L.
• Monocytes: > 0.7 Giga/L.
• Basophils: > 0.1 Giga/L.
• Eosinophils: > 0.5 Giga/L or > ULN (if ULN >= 0.5 Giga/L).

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=154 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Hb:<=115 g/L, <=95 g/L	8 Participants	5 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Hb: >=185 g/L, >=165 g/L	3 Participants	3 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Hb: DFB >=20 g/L	13 Participants	13 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Hematocrit: <= 0.37 v/v; <=0.32 v/v	12 Participants	14 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Hematocrit: >=0.55 v/v; >=0.5 v/v	5 Participants	8 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters RBCs: >=6 Tera/L	3 Participants	2 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Platelets: < 50 Giga/L	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Platelets: >=50 - 100 Giga/L	4 Participants	4 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Platelets: >= 700 Giga/L	2 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters WBC: < 3.0 Giga/L (Non-Black); < 2.0 Giga/L (Black)	34 Participants	46 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters WBC: >= 16.0 Giga/L	11 Participants	7 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Neutrophils: < 1.0 Giga/L	24 Participants	25 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Neutrophils: < 1.5 Giga/L (Non-Black); < 1.0 Giga/L (Black)	62 Participants	69 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Lymphocytes: < 0.5 Giga/L	2 Participants	3 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Lymphocytes: >= 0.5 Giga/L - LLN	28 Participants	42 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Lymphocytes: > 4.0 Giga/L	15 Participants	7 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Monocytes: > 0.7 Giga/L	48 Participants	43 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Basophils: > 0.1 Giga/L	78 Participants	70 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters Eosinophils: > 0.5 Giga/L or > ULN (if ULN >= 0.5 Giga/L)	11 Participants	14 Participants

SECONDARY outcome

Timeframe: From Week 0 to Week 24

Population: Analysis was performed on safety population (DB Period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria for potentially clinically significant abnormalities:

• Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN.
• Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN.
• Alkaline phosphatase: >1.5 ULN.
• Total bilirubin (TBILI): >1.5 ULN; >2 ULN.
• Conjugated bilirubin (CBILI): >1.5 ULN.
• Unconjugated bilirubin: >1.5 ULN, >2 ULN.
• ALT >3 ULN and TBILI >2 ULN.
• CBILI >35% TBILI and TBILI >1.5 ULN.
• Albumin: <=25 g/L.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=183 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >1 ULN and <=1.5 ULN	16 Participants	22 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >1.5 ULN and <=3 ULN	7 Participants	13 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >3 ULN and <=5 ULN	3 Participants	2 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >5 ULN and <=10 ULN	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >10 ULN and <=20 ULN	1 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >20 ULN	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests Alkaline Phosphatase >1.5 ULN	6 Participants	2 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests TBILI >1.5 ULN	1 Participants	7 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests TBILI >2 ULN	0 Participants	2 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests CBILI >1.5 ULN	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests Unconjugated Bilirubin >1.5 ULN	5 Participants	13 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests Unconjugated Bilirubin >2 ULN	1 Participants	7 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT> 3 ULN and TBILI >2 ULN	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests CBILI >35% TBILI and TBILI >1.5 ULN	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests Albumin <=25 g/L	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >1 ULN and <=1.5 ULN	22 Participants	36 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >1.5 ULN and <=3 ULN	17 Participants	26 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >3 ULN and <=5 ULN	3 Participants	5 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >5 ULN and <=10 ULN	1 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >20 ULN	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >10 ULN and <=20 ULN	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From end of Week 24 (Baseline of OLE Period) up to Week 300

Population: Analysis was performed on safety population (OLE Period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria for potentially clinically significant abnormalities:

• ALT: >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN.
• AST: >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN.
• Alkaline phosphatase: >1.5 ULN.
• TBILI: >1.5 ULN; >2 ULN.
• CBILI: >1.5 ULN.
• Unconjugated bilirubin: >1.5 ULN, >2 ULN.
• ALT >3 ULN and TBILI >2 ULN.
• CBILI >35% TBILI and TBILI >1.5 ULN.
• Albumin: <=25 g/L.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=154 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >1 ULN and <=1.5 ULN	41 Participants	36 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >1.5 ULN and <=3 ULN	31 Participants	34 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >3 ULN and <=5 ULN	11 Participants	10 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >5 ULN and <=10 ULN	1 Participants	6 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >10 ULN and <=20 ULN	0 Participants	2 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT >20 ULN	1 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >1 ULN and <=1.5 ULN	25 Participants	39 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >1.5 ULN and <=3 ULN	23 Participants	17 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >3 ULN and <=5 ULN	2 Participants	7 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >5 ULN and <=10 ULN	2 Participants	2 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >10 ULN and <=20 ULN	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests AST >20 ULN	0 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests Alkaline Phosphatase >1.5 ULN	0 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests TBILI >1.5 ULN	11 Participants	6 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests TBILI >2 ULN	3 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests CBILI >1.5 ULN	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests Unconjugated Bilirubin >1.5 ULN	21 Participants	22 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests Unconjugated Bilirubin >2 ULN	11 Participants	10 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests ALT> 3 ULN and TBILI >2 ULN	1 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests CBILI >35% TBILI and TBILI >1.5 ULN	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests Albumin <=25 g/L	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Week 0 to Week 24

Population: Analysis was performed on safety population (DB Period). Here, 'number analyzed' = participants with available data for each specified category.

Criteria for potentially clinically significant abnormalities:

• Glucose: <=3.9 millimole/liter (mmol/L) and <LLN; >=11.1 mmol/L (unfasted [unfas]) or >=7 mmol/L (fasted [fas]).
• Hemoglobin A1c (HbA1c): >8%.
• Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L.
• LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L.
• Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=184 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Glucose <=3.9 mmol/L and <LLN	10 Participants	8 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Glucose >=11.1 mmol/L (unfas) or >=7 mmol/L (fas)	17 Participants	12 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters HbA1c >8%	3 Participants	3 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Total Cholesterol >=6.2 mmol/L	52 Participants	88 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Total Cholesterol >=7.74 mmol/L	15 Participants	14 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters LDL Cholesterol >=4.1 mmol/L	35 Participants	59 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters LDL Cholesterol >=4.9 mmol/L	18 Participants	20 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Triglycerides >=4.6 mmol/L	4 Participants	8 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Triglycerides >=5.6 mmol/L	3 Participants	6 Participants

SECONDARY outcome

Timeframe: From end of Week 24 (Baseline of OLE Period) up to Week 300

Population: Analysis was performed on safety population (OLE Period). Here, 'number analyzed' = participants with available data for each specified category.

Criteria for potentially clinically significant abnormalities:

• Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L (unfas) or >=7 mmol/L (fas).
• HbA1c: >8%.
• Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L.
• LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L.
• Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=155 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Glucose <=3.9 mmol/L and <LLN	5 Participants	6 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Glucose >=11.1 mmol/L (unfas) or >=7 mmol/L (fas)	20 Participants	14 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters HbA1c >8%	2 Participants	2 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Total Cholesterol >=6.2 mmol/L	77 Participants	69 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Total Cholesterol >=7.74 mmol/L	22 Participants	19 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters LDL Cholesterol >=4.1 mmol/L	57 Participants	48 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters LDL Cholesterol >=4.9 mmol/L	25 Participants	16 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Triglycerides >=4.6 mmol/L	13 Participants	6 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Triglycerides >=5.6 mmol/L	4 Participants	6 Participants

SECONDARY outcome

Timeframe: From Week 0 to Week 24

Population: Analysis was performed on safety population (DB Period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Number of participants with different post-baseline status of HDL: < 40 mg/dL, 40 - < 60 mg/dL, >= 60 mg/dL, is reported here.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=181 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein (HDL) HDL: < 40 mg/dL	5 Participants	7 Participants
DB Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein (HDL) HDL: >=60 mg/dL	119 Participants	132 Participants
DB Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein (HDL) HDL: 40 - < 60 mg/dL	57 Participants	45 Participants

SECONDARY outcome

Timeframe: From end of Week 24 (Baseline of OLE Period) up to Week 300

Population: Analysis was performed on safety population (OLE Period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Number of participants with different post-baseline status of HDL: < 40 mg/dL, 40 - < 60 mg/dL, >=60 mg/dL, is reported here.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=153 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
OLE Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein HDL: < 40 mg/dL	7 Participants	5 Participants
OLE Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein HDL: 40 - < 60 mg/dL	52 Participants	49 Participants
OLE Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein HDL: >=60 mg/dL	94 Participants	111 Participants

SECONDARY outcome

Timeframe: From Week 0 to Week 24

Population: Analysis was performed on safety population (DB Period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria for potentially clinically significant abnormalities:

• Creatinine: >=150 micromol/L (adults); >=30% change from baseline, >=100% change from baseline.
• Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to <60 mL/min; >=60 to <90 mL/min.
• Blood urea nitrogen: >=17 mmol/L.
• Uric acid: <120 micromol/L; >408 micromol/L.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=183 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine >=150 micromol/L (Adults)	0 Participants	3 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine >=30% change from baseline	19 Participants	23 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine >=100% change from baseline	0 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine Clearance <15 mL/min	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine clearance >=15 to <30 mL/min	0 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine clearance >=30 to <60 mL/min	21 Participants	22 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine clearance >=60 to <90 mL/min	74 Participants	65 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Blood Urea Nitrogen >=17 mmol/L	0 Participants	2 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Uric acid <120 micromol/L	4 Participants	3 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Uric acid >408 micromol/L	25 Participants	35 Participants

SECONDARY outcome

Timeframe: From end of Week 24 (Baseline of OLE Period) up to Week 300

Population: Analysis was performed on safety population (OLE Period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria for potentially clinically significant abnormalities:

• Creatinine: >=150 micromol/L (adults); >=30% change from baseline, >=100% change from baseline.
• Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to <60 mL/min; >=60 to <90 mL/min.
• Blood urea nitrogen: >=17 mmol/L.
• Uric acid: <120 micromol/L; >408 micromol/L.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=154 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine >=150 micromol/L (Adults)	2 Participants	2 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine >=30% change from baseline	63 Participants	62 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine >=100% change from baseline	5 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine Clearance <15 mL/min	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine clearance >=15 to <30 mL/min	1 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine clearance >=30 to <60 mL/min	34 Participants	24 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine clearance >=60 to <90 mL/min	66 Participants	81 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Blood Urea Nitrogen >=17 mmol/L	1 Participants	3 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Uric acid <120 micromol/L	2 Participants	3 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Uric acid >408 micromol/L	44 Participants	43 Participants

SECONDARY outcome

Timeframe: From Week 0 to Week 24

Population: Analysis was performed on safety population (DB period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria with potentially clinically significant urine abnormalities:

pH: <= 4.6; pH: >= 8.0.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=87 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=85 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Urinalysis pH <= 4.6	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Urinalysis pH >= 8.0	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From end of Week 24 (Baseline of OLE Period) up to Week 300

Population: Analysis was performed on safety population (OLE Period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria with potentially clinically significant urine abnormalities:

pH: <= 4.6; pH: >= 8.0.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=105 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=109 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Urinalysis pH <= 4.6	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Urinalysis pH >= 8.0	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Week 0 to Week 24

Population: Analysis was performed on safety population (DB Period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria for potentially clinically significant abnormalities:

• Sodium: <=129 mmol/L; >=160 mmol/L.
• Potassium: <3 mmol/L; >=5.5 mmol/L.
• Chloride: <80 mmol/L; >115 mmol/L.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=183 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Sodium <=129 mmol/L	1 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Sodium >=160 mmol/L	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Potassium <3 mmol/L	3 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Potassium >=5.5 mmol/L	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Chloride <80 mmol/L	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Chloride >115 mmol/L	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From end of Week 24 (Baseline of OLE Period) up to Week 300

Population: Analysis was performed on safety population (OLE Period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria for potentially clinically significant abnormalities:

• Sodium: <=129 mmol/L; >=160 mmol/L.
• Potassium: <3 mmol/L; >=5.5 mmol/L.
• Chloride: <80 mmol/L; >115 mmol/L.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=154 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Potassium >=5.5 mmol/L	6 Participants	7 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Chloride <80 mmol/L	1 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Chloride >115 mmol/L	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Sodium <=129 mmol/L	3 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Sodium >=160 mmol/L	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes Potassium <3 mmol/L	2 Participants	2 Participants

SECONDARY outcome

Timeframe: From Week 0 to Week 24

Population: Analysis was performed on safety population (DB Period). Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.

Criteria for potentially clinically significant ECG abnormalities:

• Heart rate (HR): <50 beats per minute (bpm); <50 bpm and DFB >=20 bpm; <40 bpm; <40 bpm and DFB >=20 bpm; <30 bpm; <30 bpm and DFB >=20 bpm; >90 bpm; >=90 bpm and increase from baseline (IFB) >=20 bpm; >100 bpm; >=100 bpm and IFB >=20 bpm; >120 bpm; >=120 bpm and IFB >=20 bpm.
• PR Interval: >200 millisecond (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%.
• QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%.
• QT Interval: >500 ms.
• QTc Bazett (QTc B): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms.
• QTc Fridericia (QTc F): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=163 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=162 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR <50 bpm	4 Participants	5 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR <50 bpm and DFB >=20 bpm	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR <40 bpm	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR <40 bpm and DFB >=20 bpm	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR <30 bpm	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR <30 bpm and DFB >=20 bpm	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR >90 bpm	11 Participants	2 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR >=90 bpm and IFB >=20 bpm	5 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR >100 bpm	2 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR >=100 bpm and IFB >=20 bpm	2 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR >120 bpm	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities HR >=120 bpm and IFB >=20 bpm	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities PR Interval >200 ms	11 Participants	5 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities PR Interval >200 ms and IFB >=25%	1 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities PR Interval >220 ms	4 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities PR Interval >220 ms and IFB >=25%	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities PR Interval >240 ms	1 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities PR Interval >240 ms and IFB >=25%	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QRS Interval >110 ms	3 Participants	9 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QRS Interval >110 ms and IFB >=25%	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QRS Interval >120 ms	1 Participants	2 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QRS Interval >120 ms and IFB >=25%	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QT Interval >500 ms	0 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTc B >450 ms	16 Participants	7 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTc B >500 ms	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTc B IFB >30 and <=60 ms	11 Participants	5 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTc B IFB >60 ms	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTc F>450 ms	7 Participants	5 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTc F>480 ms	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTc F>500 ms	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTc F IFB >30 and <=60 ms	9 Participants	3 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTc F IFB >60 ms	0 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities QTc B >480 ms	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From end of Week 24 (Baseline of OLE Period) up to Week 300

Population: Analysis was performed on safety population (OLE Period). Here, 'overall number analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.

Criteria for potentially clinically significant ECG abnormalities:

• HR: <50 bpm; <50 bpm and DFB >=20 bpm; <40 bpm; <40 bpm and DFB >=20 bpm; <30 bpm; <30 bpm and DFB >=20 bpm; >90 bpm; >=90 bpm and IFB >=20 bpm; >100 bpm; >=100 bpm and IFB >=20 bpm; >120 bpm; >=120 bpm and IFB >=20 bpm.
• PR Interval: >200 ms; >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%.
• QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%.
• QT Interval: >500 ms.
• QTc B: >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms.
• QTc F: >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=154 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=163 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QRS Interval >120 ms	3 Participants	7 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR <50 bpm	10 Participants	19 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR <50 bpm and DFB >=20 bpm	0 Participants	3 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR <40 bpm	1 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR <40 bpm and DFB >=20 bpm	0 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR <30 bpm	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR <30 bpm and DFB >=20 bpm	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR >90 bpm	16 Participants	11 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR >100 bpm	3 Participants	3 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR >=100 bpm and IFB >=20 bpm	2 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR >=120 bpm and IFB >=20 bpm	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities PR Interval >200 ms	17 Participants	14 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities PR Interval >200 ms and IFB >=25%	6 Participants	3 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities PR Interval >220 ms	8 Participants	6 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QRS Interval >110 ms	8 Participants	18 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QRS Interval >110 ms and IFB >=25%	2 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QRS Interval >120 ms and IFB >=25%	1 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QT Interval >500 ms	2 Participants	2 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QTc B >450 ms	35 Participants	33 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QTc B >480 ms	3 Participants	30 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QTc B >500 ms	1 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QTc B IFB >30 and <=60 ms	18 Participants	23 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QTc B IFB >60 ms	3 Participants	2 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QTc F>450 ms	16 Participants	16 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QTc F>480 ms	3 Participants	2 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QTc F>500 ms	0 Participants	1 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QTc F IFB >30 and <=60 ms	19 Participants	19 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities QTc F IFB >60 ms	4 Participants	3 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR >=90 bpm and IFB >=20 bpm	7 Participants	6 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities HR >120 bpm	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities PR Interval >220 ms and IFB >=25%	4 Participants	3 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities PR Interval >240 ms	2 Participants	2 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities PR Interval >240 ms and IFB >=25%	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From Week 0 to Week 24

Population: Analysis was performed on safety population (DB Period). Here, 'number analyzed' = participants with available data for each specified category.

Criteria for potentially clinically significant vital sign abnormalities:

Systolic blood pressure (SBP) supine: <=95 mmHg and DFB>=20 mmHg; >=160 mmHg and IFB >=20 mmHg.

Diastolic blood pressure (DBP) supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg.

SBP (Orthostatic): <=-20 mmHg. DBP (Orthostatic): <=-10 mmHg. HR supine: <=50 bpm and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm. Weight: >=5% DFB; >=5% IFB.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=184 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=184 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities SBP (supine) <=95 mmHg and DFB >=20 mmHg	4 Participants	3 Participants
DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities SBP (supine) >=160 mmHg and IFB >=20 mmHg	4 Participants	5 Participants
DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities DBP (supine) <=45 mmHg and DFB >=10 mmHg	1 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities DBP (supine) >=110 mmHg and IFB >=10 mmHg	1 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities SBP (orthostatic) <=-20 mmHg	13 Participants	10 Participants
DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities DBP (orthostatic) <=-10 mmHg	20 Participants	27 Participants
DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities HR (supine) <=50 bpm and DFB >= 20 bpm	2 Participants	1 Participants
DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities HR (supine) >=120 bpm and IFB >=20 bpm	1 Participants	0 Participants
DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities Weight >=5% DFB	12 Participants	6 Participants
DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities Weight >=5% IFB	21 Participants	23 Participants

SECONDARY outcome

Timeframe: From end of Week 24 (Baseline of OLE Period) up to Week 300

Population: Analysis was performed on safety population (OLE Period). Here, 'number analyzed' = participants with available data for each specified category.

Criteria for potentially clinically significant vital sign abnormalities:

SBP supine: <=95 mmHg and DFB >=20 mmHg; >=160 mmHg and IFB >=20 mmHg. DBP supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg. SBP (Orthostatic): <=-20 mmHg. DBP (Orthostatic): <=-10 mmHg. HR supine: <=50 bpm and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm. Weight: >=5% DFB; >=5% IFB.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=155 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=165 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities SBP (supine) <=95 mmHg and DFB >=20 mmHg	3 Participants	9 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities SBP (supine) >=160 mmHg and IFB >=20 mmHg	10 Participants	11 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities DBP (supine) <=45 mmHg and DFB >=10 mmHg	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities DBP (supine) >=110 mmHg and IFB >=10 mmHg	1 Participants	2 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities SBP (orthostatic) <=-20 mmHg	24 Participants	32 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities DBP (orthostatic) <=-10 mmHg	41 Participants	46 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities HR (supine) <=50 bpm and DFB >= 20 bpm	3 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities HR (supine) >=120 bpm and IFB >=20 bpm	0 Participants	0 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities Weight >=5% DFB	44 Participants	51 Participants
OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities Weight >=5% IFB	82 Participants	87 Participants

SECONDARY outcome

Timeframe: From Week 0 to Week 24

Population: Analysis was performed on ADA population which consisted of all participants who had signed informed consent and had been allocated to a randomized treatment; received at least 1 dose or part of a dose of IMP with at least 1 post-dose, evaluable ADA sample. Data for this outcome measure was not planned to be collected and analyzed for Adalimumab 40 mg/Sarilumab 200 mg arm.

Anti-drug antibody response was categorized as: Treatment emergent and Treatment-boosted. Treatment emergent ADAs was defined as a participant with no positive assay response at baseline but with a positive assay response during the TEAE period. Treatment boosted ADAs: defined as participants with a positive ADA assay response at baseline and with at least a 4-fold increase in titer compared to baseline during the TEAE period. TEAE period: time from first dose of study drug up to day before first dose of open-label treatment for participants who completed 24-week randomized/DB treatment.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=184 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Number of Participants With Treatment-emergent and Treatment-boosted Anti-drug Antibody (ADA) Response Treatment-emergent ADA	13 Participants	—
DB Period: Number of Participants With Treatment-emergent and Treatment-boosted Anti-drug Antibody (ADA) Response Treatment-boosted ADA	0 Participants	—

SECONDARY outcome

Timeframe: From Week 0 up to last dose in OLE + 6 weeks of follow-up (i.e. up to Week 306)

Population: Analysis was performed on immunogenicity population which consisted of all participants who received at least 1 dose or part of a dose of IMP with at least 1 post-dose, evaluable ADA sample.

Anti-drug antibody response was categorized as: Treatment emergent and Treatment-boosted. Treatment emergent ADAs was defined as a participant with no positive assay response at baseline but with a positive assay response during the entire TEAE period. Treatment boosted ADAs: defined as participants with a positive ADA assay response at baseline and with at least a 4-fold increase in titer compared to baseline during the entire TEAE period. Entire TEAE period: last OLE dose - first DB dose date + 6 weeks (follow-up), regardless of unplanned intermittent discontinuations.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=150 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=163 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
Number of Participants With Treatment-emergent and Treatment-boosted Anti-drug Antibody Response During Entire Treatment-emergent Adverse Event Period Treatment-emergent ADAs	11 Participants	11 Participants
Number of Participants With Treatment-emergent and Treatment-boosted Anti-drug Antibody Response During Entire Treatment-emergent Adverse Event Period Treatment-boosted ADAs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, and 24

Population: Analysis was performed on Pharmacokinetics population (DB period) which consisted of all randomized Sarilumab participants who received at least 1 dose of IMP with at least one post-dose, non-missing concentration of functional Sarilumab in serum concentration value. Here, 'number analyzed' = participants with available data for each specified category.

Data for this outcome measure was not planned to be collected and analyzed for "Adalimumab 40 mg/Sarilumab 200 mg" arm.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=184 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
DB Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 12	21355.19 nanograms per milliliter (ng/mL) Standard Deviation 14805.63	—
DB Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 16	23143.39 nanograms per milliliter (ng/mL) Standard Deviation 16508.71	—
DB Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 20	25252.43 nanograms per milliliter (ng/mL) Standard Deviation 17319.04	—
DB Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 24	24233.10 nanograms per milliliter (ng/mL) Standard Deviation 17581.72	—
DB Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Baseline	0.00 nanograms per milliliter (ng/mL) Standard Deviation 0.00	—
DB Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 2	5566.03 nanograms per milliliter (ng/mL) Standard Deviation 4843.57	—
DB Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 4	11209.64 nanograms per milliliter (ng/mL) Standard Deviation 8202.70	—

SECONDARY outcome

Timeframe: Pre-dose at Week 24 (Baseline of OLE period), 36, 48, 60, 84, 108, 132, 156, 180, 204, 228, 252, 276, 300 and 306

Population: Analysis was performed on Pharmacokinetics population (OLE period) which consisted of all participants from the randomized population who received at least 1 dose of IMP with at least one post-dose, non-missing serum sarilumab concentration. Here, 'number analyzed' = participants with available data for each specified category and '0' denotes that no participant was available for the assessment at the specified timepoint.

Outcome measures

Measure	Adalimumab 40 mg/Sarilumab 200 mg n=150 Participants Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during the DB period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (\< 20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).	Sarilumab 200 mg/Sarilumab 200 mg n=163 Participants Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 24 (Baseline of OLE period)	109.38 ng/mL Standard Deviation 1237.44	24403.72 ng/mL Standard Deviation 17588.31
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 36	18952.69 ng/mL Standard Deviation 15125.86	26006.07 ng/mL Standard Deviation 19194.79
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 48	21911.87 ng/mL Standard Deviation 17926.01	25571.16 ng/mL Standard Deviation 18958.00
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 60	21583.82 ng/mL Standard Deviation 17594.87	24005.78 ng/mL Standard Deviation 18541.46
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 84	23230.92 ng/mL Standard Deviation 18274.09	23873.23 ng/mL Standard Deviation 19794.57
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 108	20405.02 ng/mL Standard Deviation 15553.02	21023.55 ng/mL Standard Deviation 17792.89
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 132	20814.89 ng/mL Standard Deviation 17848.70	20021.53 ng/mL Standard Deviation 18580.91
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 156	23604.11 ng/mL Standard Deviation 19660.31	22423.29 ng/mL Standard Deviation 18757.11
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 180	18611.01 ng/mL Standard Deviation 16417.46	21856.85 ng/mL Standard Deviation 18612.43
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 204	17982.66 ng/mL Standard Deviation 16640.61	18244.96 ng/mL Standard Deviation 16383.47
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 228	19451.40 ng/mL Standard Deviation 17694.09	18315.19 ng/mL Standard Deviation 17525.62
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 252	19663.10 ng/mL Standard Deviation 16020.11	19224.47 ng/mL Standard Deviation 16964.41
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 276	19071.00 ng/mL Standard Deviation 18425.13	17014.75 ng/mL Standard Deviation 16207.18
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 300	—	9260.00 ng/mL Standard Deviation 8683.27
OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab Week 306 (Follow-up)	1237.01 ng/mL Standard Deviation 2856.88	2280.98 ng/mL Standard Deviation 7909.71

Adverse Events

DB Period - Adalimumab 40 mg

Serious events: 13 serious events

Other events: 62 other events

Deaths: 0 deaths

DB Period - Sarilumab 200 mg

Serious events: 9 serious events

Other events: 79 other events

Deaths: 1 deaths

OLE Period - Sarilumab 200 mg

Serious events: 56 serious events

Other events: 220 other events

Deaths: 8 deaths

Serious adverse events

Measure	DB Period - Adalimumab 40 mg n=184 participants at risk Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during DB period. The dosing frequency of adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.	DB Period - Sarilumab 200 mg n=184 participants at risk Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.	OLE Period - Sarilumab 200 mg n=320 participants at risk All participants who completed 24 weeks DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to maximum of additional 276 weeks (i.e. up to Week 300).
Cardiac disorders Cardiomyopathy	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Cardiac disorders Acute myocardial infarction	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Cardiac disorders Atrial fibrillation	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Cardiac disorders Atrial flutter	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Cardiac disorders Cardiac failure acute	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Arthritis bacterial	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Bone abscess	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Bullous erysipelas	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Bursitis infective	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Epididymitis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Erysipelas	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Mastitis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Osteomyelitis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Peritonitis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Pharyngotonsillitis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Pneumonia	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	1.6% 5/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Upper respiratory tract infection	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Urinary tract infection	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Vestibular neuronitis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage II	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant mesenteric neoplasm	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer metastatic	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Yolk sac tumour site unspecified	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Blood and lymphatic system disorders Anaemia	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.62% 2/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Blood and lymphatic system disorders Neutropenia	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Immune system disorders Serum sickness	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Endocrine disorders Thyroid mass	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Nervous system disorders Cerebral ischaemia	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Nervous system disorders Cerebrovascular accident	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Nervous system disorders Demyelinating polyneuropathy	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Nervous system disorders Headache	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Nervous system disorders Intracranial aneurysm	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Nervous system disorders Multiple sclerosis	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Nervous system disorders Syncope	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Eye disorders Cataract	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.62% 2/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Eye disorders Uveitis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Cardiac disorders Coronary artery disease	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Cardiac disorders Papillary muscle rupture	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Cardiac disorders Sinus node dysfunction	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Vascular disorders Aortic dissection	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Vascular disorders Haematoma	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Vascular disorders Iliac artery occlusion	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Vascular disorders Iliac artery stenosis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Vascular disorders Peripheral ischaemia	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Vascular disorders Thrombophlebitis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Gastrointestinal disorders Inguinal hernia	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Gastrointestinal disorders Intestinal obstruction	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Gastrointestinal disorders Large intestine polyp	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Gastrointestinal disorders Pancreatic necrosis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Gastrointestinal disorders Pancreatitis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Gastrointestinal disorders Pancreatitis acute	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.62% 2/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Gastrointestinal disorders Small intestinal obstruction	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Hepatobiliary disorders Biliary obstruction	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Hepatobiliary disorders Cholelithiasis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	1.2% 4/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Hepatobiliary disorders Cholestasis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Hepatobiliary disorders Hepatic haematoma	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Musculoskeletal and connective tissue disorders Arthritis	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	1.6% 5/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.94% 3/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Renal and urinary disorders Nephrolithiasis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Renal and urinary disorders Ureterolithiasis	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Reproductive system and breast disorders Uterovaginal prolapse	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
General disorders Non-cardiac chest pain	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Investigations Alanine aminotransferase increased	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Investigations Hepatic enzyme increased	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Injury, poisoning and procedural complications Concussion	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Injury, poisoning and procedural complications Head injury	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Product Issues Device defective	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Product Issues Device dislocation	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.00% 0/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	0.31% 1/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).

Other adverse events

Measure	DB Period - Adalimumab 40 mg n=184 participants at risk Adalimumab 40 mg SC injection in combination with placebo for sarilumab q2w for 24 weeks during DB period. The dosing frequency of adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.	DB Period - Sarilumab 200 mg n=184 participants at risk Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (\<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23.	OLE Period - Sarilumab 200 mg n=320 participants at risk All participants who completed 24 weeks DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to maximum of additional 276 weeks (i.e. up to Week 300).
Infections and infestations Bronchitis	3.8% 7/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	6.5% 12/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	12.8% 41/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Nasopharyngitis	7.6% 14/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	6.0% 11/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	18.8% 60/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Upper respiratory tract infection	3.8% 7/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	1.6% 3/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	11.2% 36/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Infections and infestations Urinary tract infection	2.2% 4/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	2.7% 5/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	9.4% 30/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Blood and lymphatic system disorders Neutropenia	0.54% 1/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	13.6% 25/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	18.4% 59/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Nervous system disorders Headache	6.5% 12/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	3.8% 7/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	5.3% 17/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Vascular disorders Hypertension	1.6% 3/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	2.2% 4/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	8.8% 28/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Gastrointestinal disorders Diarrhoea	3.3% 6/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	2.7% 5/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	6.2% 20/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Musculoskeletal and connective tissue disorders Back pain	1.6% 3/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	1.6% 3/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	6.6% 21/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	3.8% 7/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	1.6% 3/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	6.6% 21/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
General disorders Injection site erythema	3.8% 7/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	7.6% 14/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	8.1% 26/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Investigations Alanine aminotransferase increased	3.3% 6/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	3.8% 7/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	7.2% 23/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).
Injury, poisoning and procedural complications Accidental overdose	6.0% 11/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	2.7% 5/184 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).	12.2% 39/320 • All Adverse Events (AEs) were collected from up to Week 24 in DB period and from end of Week 24 (Baseline of OLE Period) up to Week 306 in OLE Period regardless of seriousness or relationship to study drug. Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (DB: time from first dose of study drug up to day before first dose of open-label treatment; OLE: from end of Week 24 \[Baseline of OLE Period\] up to last dose in OLE + 6 weeks \[follow-up\]). Analyzed on Safety population. For OLE, data was reported for pooled population (all participants received Sarilumab).

Additional Information

Trial Transparency Team

Sanofi

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Results disclosure agreements

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Restriction type: OTHER