Trial Outcomes & Findings for Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis (NCT NCT03449758)

NCT ID: NCT03449758

Last Updated: 2022-04-28

Results Overview

RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological well-being, • sleep disturbance, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 84 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2022-04-28

Participant Flow

The study was conducted at 31 active centers in France. A total of 104 participants were screened between 05 March 2018 to 27 December 2018, of which 20 were screen failures. Screen failures were mainly due to inclusion criteria not met.

A total of 84 participants were enrolled and received treatment.

Participant milestones

Measure	Sarilumab Sarilumab 200 mg subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARD) during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Overall Study STARTED	84
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure	Sarilumab Sarilumab 200 mg subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARD) during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Overall Study Major protocol deviation	1
Overall Study Treatment inefficacy	5
Overall Study Adverse Event	9
Overall Study Consent withdrawal	1
Overall Study Other unspecified reason	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Age, Continuous	59.1 years STANDARD_DEVIATION 12.3 • n=84 Participants
Sex: Female, Male Female	63 Participants n=84 Participants
Sex: Female, Male Male	21 Participants n=84 Participants
Rheumatoid Arthritis Impact of Disease (RAID) - Baseline Total Score	5.8 score on a scale STANDARD_DEVIATION 1.9 • n=84 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological well-being, • sleep disturbance, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.

Outcome measures

Measure

Sarilumab n=62 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.

Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Week 24

-2.4 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological well-being, • sleep disturbances, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Rheumatoid Arthritis Impact of Disease Total Score at Baseline, Weeks 4, 12 and 24 Week 4	4.6 score on a scale Standard Deviation 2.1
Rheumatoid Arthritis Impact of Disease Total Score at Baseline, Weeks 4, 12 and 24 Week 12	3.9 score on a scale Standard Deviation 2.3
Rheumatoid Arthritis Impact of Disease Total Score at Baseline, Weeks 4, 12 and 24 Week 24	3.3 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline, Weeks 4 and 12

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

RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological wellbeing, • sleep disturbance, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Weeks 4 and 12 Week 4	-1.2 score on a scale Standard Deviation 1.6
Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Weeks 4 and 12 Week 12	-1.8 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

HADS questionnaire measures the presence and severity of anxiety and depression in both hospital and community settings. The questionnaire comprised of 14 items divided into 2 subscales: 7 items for anxiety subscale (HADS-A) and 7 items for depression subscale (HADS-D). Each item was scored on a 0 to 3 rating scale. The anxiety and depression subscales each ranged from 0 to 21 (0-7: normal, 8-10: borderline abnormal and 11-21: abnormal), where higher scores indicated greater severity of anxiety/depression. The subscales were independent for each result of depression and anxiety.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24 HADS-A: Baseline	8.1 score on a scale Standard Deviation 4.3
Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24 HADS-A: Week 4	7.2 score on a scale Standard Deviation 4.3
Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24 HADS-A: Week 12	6.1 score on a scale Standard Deviation 3.7
Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24 HADS-A: Week 24	6.6 score on a scale Standard Deviation 3.9
Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24 HADS-D: Baseline	7.0 score on a scale Standard Deviation 3.9
Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24 HADS-D: Week 4	6.6 score on a scale Standard Deviation 4.0
Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24 HADS-D: Week 12	5.7 score on a scale Standard Deviation 4.1
Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24 HADS-D: Week 24	5.5 score on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

HADS questionnaire measures the presence and severity of anxiety and depression in both hospital and community settings. The questionnaire comprised of 14 items divided into 2 subscales: 7 items for anxiety subscale (HADS-A) and 7 items for depression subscale (HADS-D). Each item was scored on a 0 to 3 rating scale. The anxiety and depression subscales each ranged from 0 to 21 (0-7: normal, 8-10: borderline abnormal and 11-21: abnormal), where higher scores indicated greater severity of anxiety/depression. The subscales were independent for each result of depression and anxiety.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Weeks 4, 12 and 24 HADS-A: Week 4	-1.0 score on a scale Standard Deviation 2.4
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Weeks 4, 12 and 24 HADS-A: Week 12	-2.1 score on a scale Standard Deviation 3.3
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Weeks 4, 12 and 24 HADS-A: Week 24	-1.9 score on a scale Standard Deviation 3.2
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Weeks 4, 12 and 24 HADS-D: Week 4	-0.4 score on a scale Standard Deviation 2.5
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Weeks 4, 12 and 24 HADS-D: Week 12	-1.2 score on a scale Standard Deviation 4.1
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Weeks 4, 12 and 24 HADS-D: Week 24	-1.7 score on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

MAThyS was a multi-dimensional self-administered questionnaire comprised of five dimensions (emotional reactivity, cognition speed, psychomotor function, motivation and sensory perception) divided into 20 items relating to individual states as perceived by participants for the preceding week (at each specified Week). Each item was measured on a visual analog scale (VAS; in centimeters [cm]) ranged from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state). Total MAThyS score was sum of the 20 items and that might vary from score range 0 to 200 with lower scores indicated general inhibition and higher scores indicated general excitation.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Multidimensional Assessment of Thymic States (MAThyS) Scale Total Score at Baseline, Weeks 4, 12 and 24 Baseline	88.4 cm Standard Deviation 21.1
Multidimensional Assessment of Thymic States (MAThyS) Scale Total Score at Baseline, Weeks 4, 12 and 24 Week 4	89.6 cm Standard Deviation 20.3
Multidimensional Assessment of Thymic States (MAThyS) Scale Total Score at Baseline, Weeks 4, 12 and 24 Week 12	94.8 cm Standard Deviation 13.6
Multidimensional Assessment of Thymic States (MAThyS) Scale Total Score at Baseline, Weeks 4, 12 and 24 Week 24	90.9 cm Standard Deviation 22.3

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

MAThyS was a multi-dimensional self-administered questionnaire comprised of five dimensions (emotional reactivity, cognition speed, psychomotor function, motivation and sensory perception) divided into 20 items relating to individual states as perceived by participants for the preceding week (at each specified Week). Each item was measured on a VAS (in cm) ranging from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state). Total MAThyS score was sum of the 20 items and that might vary from score range 0 to 200 with lower scores indicated general inhibition and higher scores indicated general excitation.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Multidimensional Assessment of Thymic States Scale Total Score at Weeks 4, 12 and 24 Week 4	-0.2 cm Standard Deviation 24.2
Change From Baseline in Multidimensional Assessment of Thymic States Scale Total Score at Weeks 4, 12 and 24 Week 12	2.9 cm Standard Deviation 17.7
Change From Baseline in Multidimensional Assessment of Thymic States Scale Total Score at Weeks 4, 12 and 24 Week 24	-1.1 cm Standard Deviation 23.4

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

FACIT-F was a 13-item questionnaire that assess fatigue in participants under chronic illness therapy. Participants scored each item on a 5-point Likert scale ranged from 0 to 4 (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The scores of each item were reversed during score calculations, so that higher score values indicated more favorable conditions. Total score was the sum of score from each item and resulted in a score range from 0 to 52, with higher score indicated better participant health status (lower level of fatigue).

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Scores at Baseline, Weeks 4, 12 and 24 Baseline	25.5 score on a scale Standard Deviation 10.3
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Scores at Baseline, Weeks 4, 12 and 24 Week 4	21.0 score on a scale Standard Deviation 10.5
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Scores at Baseline, Weeks 4, 12 and 24 Week 12	18.8 score on a scale Standard Deviation 9.7
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Scores at Baseline, Weeks 4, 12 and 24 Week 24	17.9 score on a scale Standard Deviation 11.4

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

FACIT-F was a 13-item questionnaire that assess fatigue in participants under chronic illness therapy. Participants scored each item on a 5-point Likert scale ranged from 0 to 4 (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The scores of each item were reversed during score calculations, so that higher score values indicated more favorable conditions. Total score was the sum of score from each item and resulted in a score range from 0 to 52, with higher score indicated better participant health status (lower level of fatigue).

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Total Scores at Weeks 4, 12 and 24 Week 4	-4.8 score on a scale Standard Deviation 8.0
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Total Scores at Weeks 4, 12 and 24 Week 12	-6.4 score on a scale Standard Deviation 9.1
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Total Scores at Weeks 4, 12 and 24 Week 24	-7.6 score on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

HAQ-DI was a participant-oriented questionnaire developed specifically to assess the extent of a RA participant's functional ability. 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 (at each specified visit) 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, and ranged from 0 to 3, where 0 = no disability and 3 = completely disabled, higher score indicated more disability.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 4, 12 and 24 Baseline	1.3 score on a scale Standard Deviation 0.8
Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 4, 12 and 24 Week 4	1.1 score on a scale Standard Deviation 0.7
Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 4, 12 and 24 Week 12	0.8 score on a scale Standard Deviation 0.7
Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 4, 12 and 24 Week 24	0.8 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

HAQ-DI was a participant-oriented questionnaire developed specifically to assess the extent of a RA participant's functional ability. 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 (at each specified visit) 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, and ranged from 0 to 3, where 0 = no disability and 3 = completely disabled, higher score indicated more disability.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Stanford Health Assessment Questionnaire Disability Index Total Score at Weeks 4, 12 and 24 Week 4	-0.2 score on a scale Standard Deviation 0.5
Change From Baseline in Stanford Health Assessment Questionnaire Disability Index Total Score at Weeks 4, 12 and 24 Week 12	-0.4 score on a scale Standard Deviation 0.6
Change From Baseline in Stanford Health Assessment Questionnaire Disability Index Total Score at Weeks 4, 12 and 24 Week 24	-0.5 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. At each specified time point, duration of morning stiffness was reported by the participant during the visit.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Duration of Morning Stiffness at Baseline, Weeks 4, 12, and 24 Baseline	72.3 minutes Standard Deviation 75.0
Duration of Morning Stiffness at Baseline, Weeks 4, 12, and 24 Week 4	34.7 minutes Standard Deviation 43.9
Duration of Morning Stiffness at Baseline, Weeks 4, 12, and 24 Week 12	28.9 minutes Standard Deviation 47.2
Duration of Morning Stiffness at Baseline, Weeks 4, 12, and 24 Week 24	21.3 minutes Standard Deviation 37.5

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. At each specified time point, duration of morning stiffness was reported by the participant during the visit.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Duration of Morning Stiffness at Weeks 4, 12, and 24 Week 4	-39.9 minutes Standard Deviation 67.9
Change From Baseline in Duration of Morning Stiffness at Weeks 4, 12, and 24 Week 12	-47.9 minutes Standard Deviation 76.8
Change From Baseline in Duration of Morning Stiffness at Weeks 4, 12, and 24 Week 24	-52.8 minutes Standard Deviation 72.3

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

IPAQ was a 27-item self-reported questionnaire designed to measure physical activity of participant. The score was reported in metabolic equivalent (MET)-minutes per week. MET minutes represented the amount of energy expended to carry out physical activity. For IPAQ total score, the minimum value is zero and there is no maximum. Higher scores mean better levels of physical activity.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
International Physical Activity Questionnaire (IPAQ) Total Score at Baseline, Weeks 4, 12 and 24 Baseline	1759.9 MET minutes per week Standard Deviation 1185.0
International Physical Activity Questionnaire (IPAQ) Total Score at Baseline, Weeks 4, 12 and 24 Week 4	1881.1 MET minutes per week Standard Deviation 1203.9
International Physical Activity Questionnaire (IPAQ) Total Score at Baseline, Weeks 4, 12 and 24 Week 12	2061.0 MET minutes per week Standard Deviation 1266.9
International Physical Activity Questionnaire (IPAQ) Total Score at Baseline, Weeks 4, 12 and 24 Week 24	2089.5 MET minutes per week Standard Deviation 1476.4

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

IPAQ was a 27-item self-reported questionnaire designed to measure physical activity of participant. The score was reported in MET minutes per week. MET minutes represented the amount of energy expended to carry out physical activity. For IPAQ total score, the minimum value is zero and there is no maximum. Higher scores mean better levels of physical activity.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in International Physical Activity Questionnaire Total Score at Weeks 4, 12 and 24 Week 4	175.6 MET minutes per week Standard Deviation 1177.7
Change From Baseline in International Physical Activity Questionnaire Total Score at Weeks 4, 12 and 24 Week 12	533.4 MET minutes per week Standard Deviation 1509.7
Change From Baseline in International Physical Activity Questionnaire Total Score at Weeks 4, 12 and 24 Week 24	382.0 MET minutes per week Standard Deviation 1719.8

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

PtGA of disease activity was measured using a 100 millimeters (mm) horizontal VAS ranged from 0=no pain to 100=maximum pain imaginable, where higher score indicated more disease activity.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Patient Global Assessment (PtGA) of Disease Activity Score by Visual Analog Scale (VAS) at Baseline, Weeks 4, 12 and 24 Baseline	61.1 mm Standard Deviation 22.4
Patient Global Assessment (PtGA) of Disease Activity Score by Visual Analog Scale (VAS) at Baseline, Weeks 4, 12 and 24 Week 4	44.1 mm Standard Deviation 25.6
Patient Global Assessment (PtGA) of Disease Activity Score by Visual Analog Scale (VAS) at Baseline, Weeks 4, 12 and 24 Week 12	36.6 mm Standard Deviation 26.7
Patient Global Assessment (PtGA) of Disease Activity Score by Visual Analog Scale (VAS) at Baseline, Weeks 4, 12 and 24 Week 24	34.6 mm Standard Deviation 25.6

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

PtGA of disease activity was measured using a 100 mm horizontal VAS ranged from 0=no pain to 100=maximum pain imaginable, where higher score indicated more disease activity.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Patient Global Assessment of Disease Activity Score by Visual Analog Scale at Weeks 4, 12, and 24 Week 4	-17.2 mm Standard Deviation 24.2
Change From Baseline in Patient Global Assessment of Disease Activity Score by Visual Analog Scale at Weeks 4, 12, and 24 Week 12	-24.3 mm Standard Deviation 31.8
Change From Baseline in Patient Global Assessment of Disease Activity Score by Visual Analog Scale at Weeks 4, 12, and 24 Week 24	-26.7 mm Standard Deviation 29.6

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

ESR was a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h).

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Erythrocyte Sedimentation Rate (ESR) at Baseline, Weeks 4, 12, and 24 Baseline	28.8 mm/h Standard Deviation 23.4
Erythrocyte Sedimentation Rate (ESR) at Baseline, Weeks 4, 12, and 24 Week 4	10.5 mm/h Standard Deviation 15.5
Erythrocyte Sedimentation Rate (ESR) at Baseline, Weeks 4, 12, and 24 Week 12	9.2 mm/h Standard Deviation 15.3
Erythrocyte Sedimentation Rate (ESR) at Baseline, Weeks 4, 12, and 24 Week 24	8.4 mm/h Standard Deviation 11.3

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

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

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24 Week 4	-18.1 mm/h Standard Deviation 21.1
Change From Baseline in Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24 Week 12	-19.5 mm/h Standard Deviation 25.1
Change From Baseline in Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24 Week 24	-22.0 mm/h Standard Deviation 23.2

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

DAS28-ESR was a composite score that included 4 variables: tender joint count (TJC) (based on 28 joints); swollen joint count (SJC) (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score ranged from 0-10, higher score indicated more disease activity. The DAS28-ESR score provided a number indicating the current disease activity of the RA. A DAS28-ESR score above 5.1 indicated high disease activity, DAS28-ESR score less than or equal to (<=) 3.2 indicated low disease activity (LDA), greater than (>) 3.2 to <=5.1 implied moderate disease activity and DAS28-ESR score below 2.6 indicated disease remission.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline, Weeks 4, 12, and 24 Baseline	5.0 score on a scale Standard Deviation 1.2
Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline, Weeks 4, 12, and 24 Week 4	3.1 score on a scale Standard Deviation 1.5
Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline, Weeks 4, 12, and 24 Week 12	2.6 score on a scale Standard Deviation 1.5
Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline, Weeks 4, 12, and 24 Week 24	2.3 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

DAS28-ESR was a composite score that included 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score ranged from 0-10, higher score indicated more disease activity. The DAS28-ESR score provided a number indicating the current disease activity of the RA. A DAS28-ESR score above 5.1 indicated high disease activity, DAS28-ESR score <= 3.2 indicated LDA, > 3.2 to <=5.1 implied moderate disease activity and DAS28-ESR score below 2.6 indicated disease remission.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24 Week 4	-1.8 score on a scale Standard Deviation 1.1
Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24 Week 12	-2.3 score on a scale Standard Deviation 1.6
Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24 Week 24	-2.7 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

CDAI was 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 disease activity (in cm), and physician's global assessment of disease (in cm). CDAI total score ranges from 0 to 76 with a lower score indicating less disease activity. A CDAI score of <=2.8 represents clinical remission and a score of <=10.0 represents LDA.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Clinical Disease Activity Index (CDAI) Total Score at Baseline, Weeks 4, 12, and 24 Baseline	22.5 score on a scale Standard Deviation 11.2
Clinical Disease Activity Index (CDAI) Total Score at Baseline, Weeks 4, 12, and 24 Week 4	12.6 score on a scale Standard Deviation 9.8
Clinical Disease Activity Index (CDAI) Total Score at Baseline, Weeks 4, 12, and 24 Week 12	9.9 score on a scale Standard Deviation 10.4
Clinical Disease Activity Index (CDAI) Total Score at Baseline, Weeks 4, 12, and 24 Week 24	8.1 score on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

CDAI was 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 disease activity (in cm), and physician's global assessment of disease (in cm). CDAI total score ranges from 0 to 76 with a lower score indicating less disease activity. A CDAI score of <=2.8 represents clinical remission and a score of <=10.0 represents LDA.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Clinical Disease Activity Index Total Score at Weeks 4, 12, and 24 Week 4	-9.8 score on a scale Standard Deviation 8.1
Change From Baseline in Clinical Disease Activity Index Total Score at Weeks 4, 12, and 24 Week 12	-12.2 score on a scale Standard Deviation 13.2
Change From Baseline in Clinical Disease Activity Index Total Score at Weeks 4, 12, and 24 Week 24	-14.6 score on a scale Standard Deviation 12.6

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

Number of joints with swelling are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Number of Swollen Joints at Baseline, Weeks 4, 12, and 24 Baseline	6.3 joints Standard Deviation 5.1
Number of Swollen Joints at Baseline, Weeks 4, 12, and 24 Week 4	2.5 joints Standard Deviation 3.2
Number of Swollen Joints at Baseline, Weeks 4, 12, and 24 Week 12	1.9 joints Standard Deviation 3.6
Number of Swollen Joints at Baseline, Weeks 4, 12, and 24 Week 24	1.6 joints Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

Number of joints with swelling are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Number of Swelling Joints at Weeks 4, 12, and 24 Week 4	-3.9 joints Standard Deviation 4.3
Change From Baseline in Number of Swelling Joints at Weeks 4, 12, and 24 Week 12	-4.1 joints Standard Deviation 5.1
Change From Baseline in Number of Swelling Joints at Weeks 4, 12, and 24 Week 24	-4.7 joints Standard Deviation 5.2

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

Number of joints with tenderness are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Number of Tender Joints at Baseline, Weeks 4, 12, and 24 Baseline	7.3 joints Standard Deviation 5.8
Number of Tender Joints at Baseline, Weeks 4, 12, and 24 Week 4	4.7 joints Standard Deviation 5.4
Number of Tender Joints at Baseline, Weeks 4, 12, and 24 Week 12	3.5 joints Standard Deviation 5.2
Number of Tender Joints at Baseline, Weeks 4, 12, and 24 Week 24	2.5 joints Standard Deviation 4.1

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12 and 24

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

Number of joints with tenderness are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Change From Baseline in Number of Tender Joints at Weeks 4, 12, and 24 Week 4	-2.5 joints Standard Deviation 4.5
Change From Baseline in Number of Tender Joints at Weeks 4, 12, and 24 Week 12	-3.7 joints Standard Deviation 6.5
Change From Baseline in Number of Tender Joints at Weeks 4, 12, and 24 Week 24	-4.8 joints Standard Deviation 6.4

SECONDARY outcome

Timeframe: Weeks 12 and 24

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

DAS28-ESR was a composite score that included 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable) marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score ranged from 0-10, higher score indicated more disease activity. The DAS28-ESR score provided a number indicating the current disease activity of the RA. A DAS28-ESR score above 5.1 indicated high disease activity, DAS28-ESR score <= 3.2 indicated LDA, > 3.2 to <=5.1 implied moderate disease activity and DAS28-ESR score below 2.6 indicated disease remission.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Number of Participants Achieving Low Disease Activity (DAS28 ESR Score <=3.2) and Remission (DAS28 ESR Score <2.6) at Weeks 12, and 24 LDA: Week 12	12 Participants
Number of Participants Achieving Low Disease Activity (DAS28 ESR Score <=3.2) and Remission (DAS28 ESR Score <2.6) at Weeks 12, and 24 LDA: Week 24	4 Participants
Number of Participants Achieving Low Disease Activity (DAS28 ESR Score <=3.2) and Remission (DAS28 ESR Score <2.6) at Weeks 12, and 24 Remission: Week 12	40 Participants
Number of Participants Achieving Low Disease Activity (DAS28 ESR Score <=3.2) and Remission (DAS28 ESR Score <2.6) at Weeks 12, and 24 Remission: Week 24	45 Participants

SECONDARY outcome

Timeframe: Weeks 12 and 24

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

CDAI was a composite index constructed to measure clinical remission in RA that does not included a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global disease activity (in cm), and physician's global assessment (in cm). Total score ranged from 0 to 76 with a lower score indicated less disease activity. A CDAI score of <=2.8 represents clinical remission and a score of <=10.0 represents LDA.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Number of Participants Achieving Clinical Disease Activity Index: Low Disease Activity (CDAI Score <=10.0) and Remission (CDAI Score <=2.8) Weeks 12, and 24 LDA: Week 12	29 Participants
Number of Participants Achieving Clinical Disease Activity Index: Low Disease Activity (CDAI Score <=10.0) and Remission (CDAI Score <=2.8) Weeks 12, and 24 LDA: Week 24	29 Participants
Number of Participants Achieving Clinical Disease Activity Index: Low Disease Activity (CDAI Score <=10.0) and Remission (CDAI Score <=2.8) Weeks 12, and 24 Remission: Week 12	18 Participants
Number of Participants Achieving Clinical Disease Activity Index: Low Disease Activity (CDAI Score <=10.0) and Remission (CDAI Score <=2.8) Weeks 12, and 24 Remission: Week 24	20 Participants

SECONDARY outcome

Timeframe: Baseline up to end of study (up to 39.7 weeks)

Population: Analysis was performed on safety population which included participants who signed the informed consent form and had exposed to at least one dose or part of a dose of study drug.

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the study treatment. SAE: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks.

Outcome measures

Measure	Sarilumab n=84 Participants Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAE	10 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAE	76 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) AE leading to death	0 Participants

Adverse Events

Sarilumab

Serious events: 10 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sarilumab n=84 participants at risk Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to 39.7 weeks.
Blood and lymphatic system disorders Neutropenia	1.2% 1/84 • Number of events 2 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Immune system disorders Drug Hypersensitivity	1.2% 1/84 • Number of events 1 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Infections and infestations Pneumonia	1.2% 1/84 • Number of events 1 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	1.2% 1/84 • Number of events 1 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Arthritis	1.2% 1/84 • Number of events 1 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Back Pain	1.2% 1/84 • Number of events 1 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	1.2% 1/84 • Number of events 1 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	1.2% 1/84 • Number of events 2 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Nervous system disorders Polyneuropathy	1.2% 1/84 • Number of events 1 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	1.2% 1/84 • Number of events 1 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Angioedema	1.2% 1/84 • Number of events 2 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Urticaria	1.2% 1/84 • Number of events 1 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.

Other adverse events

Measure	Sarilumab n=84 participants at risk Sarilumab 200 mg SC injection q2w from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with MTX or other csDMARD during the randomized 6-months (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to 39.7 weeks.
Blood and lymphatic system disorders Neutropenia	19.0% 16/84 • Number of events 19 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Gastrointestinal disorders Diarrhoea	6.0% 5/84 • Number of events 5 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Gastrointestinal disorders Nausea	11.9% 10/84 • Number of events 11 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
General disorders Asthenia	10.7% 9/84 • Number of events 10 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
General disorders Fatigue	10.7% 9/84 • Number of events 9 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
General disorders Injection Site Erythema	6.0% 5/84 • Number of events 7 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
General disorders Injection Site Pruritus	6.0% 5/84 • Number of events 6 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Infections and infestations Bronchitis	11.9% 10/84 • Number of events 11 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Infections and infestations Nasopharyngitis	10.7% 9/84 • Number of events 10 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Nervous system disorders Headache	10.7% 9/84 • Number of events 10 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Pruritus	7.1% 6/84 • Number of events 6 • All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug. Reported AEs were TEAEs which were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks. Analysis was performed on safety population.

Additional Information

Trial Transparency Team

Sanofi

Phone: 800-633-1610

Email: Contact-US@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
• Publication restrictions are in place

Restriction type: OTHER