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To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

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ClinicalTrials.gov Identifier: NCT01709578
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : August 8, 2017
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Sarilumab
Drug: placebo
Drug: hydroxychloroquine
Drug: methotrexate
Drug: sulfasalazine
Drug: leflunomide
Enrollment 546
Recruitment Details The study was conducted at 240 centers in 27 countries. A total of 1224 participants were screened between 29 October 2012 and 7 August 2014, of whom 546 participants were randomized and 678 were screen failures. Screen failures were mainly due to failure to meet inclusion criteria.
Pre-assignment Details Participants were randomized 1:1:1 (placebo q2w : sarilumab 150 mg q2w : sarilumab 200 mg q2w) via a centralized randomization system using an interactive voice response system stratified by region and number of previous anti- tumor necrosis factor (TNF) therapy (1 versus >1).
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description Placebo matched to sarilumab subcutaneous (SC) injection once every 2 weeks (q2w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD) for 24 weeks. Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Period Title: Overall Study
Started 181 181 184
Completed 101 125 133
Not Completed 80 56 51
Reason Not Completed
Rescued and entered in long term safety             63             25             26
Adverse Event             9             18             17
Lack of Efficacy             5             4             2
Poor compliance to protocol             1             2             1
Other, not related to safety or efficacy             2             7             5
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w Total
Hide Arm/Group Description Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 181 181 184 546
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 181 participants 181 participants 184 participants 546 participants
51.9  (12.4) 54.0  (11.7) 52.9  (12.9) 52.9  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 181 participants 184 participants 546 participants
Female
154
  85.1%
142
  78.5%
151
  82.1%
447
  81.9%
Male
27
  14.9%
39
  21.5%
33
  17.9%
99
  18.1%
1.Primary Outcome
Title Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24
Hide Description ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant (C-reactive Protein levels [CRP]); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by (health assessment questionnaire disability index [HAQ-DI]). ACR20 is 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 of the ACR.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 181 181 184
Measure Type: Number
Unit of Measure: percentage of participants
33.7 55.8 60.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 150 mg q2w
Comments A hierarchical testing procedure was used to control type I error rate at 0.05 and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.025 level
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.711
Confidence Interval (2-Sided) 95%
1.730 to 4.247
Estimation Comments Sarilumab 150 mg q2w vs Placebo q2w
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 200 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.025 level
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.284
Confidence Interval (2-Sided) 95%
2.108 to 5.115
Estimation Comments Sarilumab 200 mg q2w vs Placebo q2w
2.Primary Outcome
Title Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
Hide Description Physical function was assessed by HAQ-DI. It consisted of at least 2 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. Least-squares (LS) means and standard errors (SE) at Week 12 were obtained from a mixed-effect model with repeated measures (MMRM) with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = number of participants with HAQ-DI assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 170 165 171
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.26  (0.043) -0.46  (0.044) -0.47  (0.043)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 150 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments Threshold for significance at 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.202
Confidence Interval (2-Sided) 95%
-0.318 to -0.086
Estimation Comments Sarilumab 150 mg q2w vs Placebo q2w
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 200 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments Threshold for significance at 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.210
Confidence Interval (2-Sided) 95%
-0.325 to -0.095
Estimation Comments Sarilumab 200 mg q2w vs Placebo q2w
3.Secondary Outcome
Title Change From Baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 24
Hide Description DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline DAS28-CRP score as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = number of participants with DAS28--CRP Score assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 99 126 136
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.38  (0.119) -2.35  (0.111) -2.82  (0.108)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 150 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.971
Confidence Interval (2-Sided) 95%
-1.283 to -0.658
Estimation Comments Sarilumab 150 mg q2w vs Placebo q2w
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 200 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.444
Confidence Interval (2-Sided) 95%
-1.752 to -1.135
Estimation Comments Sarilumab 200 mg q2w vs Placebo q2w
4.Secondary Outcome
Title Percentage of Participants Achieving ACR50 Criteria at Week 24
Hide Description ACR responses are assessed with a composite rating scale that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 181 181 184
Measure Type: Number
Unit of Measure: Percentage of participants
18.2 37.0 40.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 150 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.025 level
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.958
Confidence Interval (2-Sided) 95%
1.764 to 4.959
Estimation Comments Sarilumab 150 mg q2w vs Placebo q2w
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 200 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance was 0.025 level
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.374
Confidence Interval (2-Sided) 95%
2.045 to 5.566
Estimation Comments Sarilumab 200 mg q2w vs Placebo q2w
5.Secondary Outcome
Title Percentage of Participants Achieving ACR70 Criteria at Week 24
Hide Description ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is 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 of the ACR.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 181 181 184
Measure Type: Number
Unit of Measure: Percentage of participants
7.2 19.9 16.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 150 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Threshold for significance at 0.025 level
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.607
Confidence Interval (2-Sided) 95%
1.774 to 7.332
Estimation Comments Sarilumab 150 mg q2w vs Placebo q2w
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 200 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0056
Comments Threshold for significance at 0.025 level
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.653
Confidence Interval (2-Sided) 95%
1.308 to 5.383
Estimation Comments Sarilumab 200 mg q2w vs Placebo q2w
6.Secondary Outcome
Title Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 24
Hide Description DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR rheumatoid arthritis core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 181 181 184
Measure Type: Number
Unit of Measure: Percentage of participants
7.2 24.9 28.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 150 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.025 level
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.622
Confidence Interval (2-Sided) 95%
2.339 to 9.132
Estimation Comments Sarilumab 150 mg q2w vs Placebo q2w
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 200 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.025 level
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.801
Confidence Interval (2-Sided) 95%
2.948 to 11.413
Estimation Comments Sarilumab 200 mg q2w vs Placebo q2w
7.Secondary Outcome
Title Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24
Hide Description 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: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline CDAI as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed=number of participants with CDAI assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 100 127 136
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-16.35  (1.195) -23.65  (1.136) -26.08  (1.109)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 150 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.306
Confidence Interval (2-Sided) 95%
-10.444 to -4.167
Estimation Comments Sarilumab 150 mg q2w vs Placebo q2w
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 200 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.727
Confidence Interval (2-Sided) 95%
-12.833 to -6.622
Estimation Comments Sarilumab 200 mg q2w vs Placebo q2w
8.Secondary Outcome
Title Change From Baseline in HAQ-DI at Week 24
Hide Description Physical function was assessed by HAQ-DI. It consisted of at least 2 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 means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = number of participants with HAQ-DI assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 101 127 136
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.34  (0.051) -0.52  (0.049) -0.58  (0.048)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 150 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments Threshold for significance was 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.183
Confidence Interval (2-Sided) 95%
-0.318 to -0.048
Estimation Comments Sarilumab 150 mg q2w vs Placebo q2w
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 200 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments Threshold for significance was 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.242
Confidence Interval (2-Sided) 95%
-0.376 to -0.109
Estimation Comments Sarilumab 200 mg q2w vs Placebo q2w
9.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Component Summary Scores (PCS) at Week 24
Hide Description SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS had 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS had 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 subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 24 by MMRM with treatment,region,number of previous anti TNFs,visit,and treatment-by-visit interaction as fixed effects and baseline SF-36 (PCS) as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with SF-36 PCS assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 99 123 134
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.40  (0.692) 7.65  (0.653) 8.48  (0.630)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 150 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments Threshold for significance at 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.250
Confidence Interval (2-Sided) 95%
1.450 to 5.049
Estimation Comments Sarilumab 150 mg q2w vs Placebo q2w
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 200 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.075
Confidence Interval (2-Sided) 95%
2.305 to 5.846
Estimation Comments Sarilumab 200 mg q2w vs Placebo q2w
10.Secondary Outcome
Title Change From Baseline in SF-36 MCS at Week 24
Hide Description SF-36 is a generic 36-item questionnaire measuring HRQL covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 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 subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline SF-36 MCS as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed=participants with SF-36 MCS assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 99 123 134
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.74  (0.902) 6.26  (0.848) 6.76  (0.817)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 150 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2026
Comments Threshold for significance at 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.515
Confidence Interval (2-Sided) 95%
-0.818 to 3.848
Estimation Comments Sarilumab 150 mg q2w vs Placebo q2w
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo q2w, Sarilumab 200 mg q2w
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0854
Comments Threshold for significance at 0.025 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.013
Confidence Interval (2-Sided) 95%
-0.282 to 4.309
Estimation Comments Sarilumab 200 mg q2w vs Placebo q2w
11.Secondary Outcome
Title Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-fatigue) Score at Week 24
Hide Description The FACIT-Fatigue 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 ranging from 0 to 52. A higher score corresponded to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline FACIT-fatigue as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of Participants analyzed = number of participants with FACIT-fatigue score assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 98 126 136
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
6.82  (0.863) 9.86  (0.802) 10.06  (0.778)
12.Secondary Outcome
Title Change From Baseline in Morning Stiffness VAS at Week 24
Hide Description 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 from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline Morning Stiffness as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = number of participants with morning stiffness VAS assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 101 127 136
Least Squares Mean (Standard Error)
Unit of Measure: mm
-21.66  (2.390) -32.30  (2.213) -33.79  (2.148)
13.Secondary Outcome
Title Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to RA
Hide Description 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 was interviewer-administered and was 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 from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed=participants with WPS-RA individual items assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 32 43 45
Least Squares Mean (Standard Error)
Unit of Measure: Days
-2.01  (0.458) -2.87  (0.438) -3.19  (0.447)
14.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to RA
Hide Description 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 was interviewer-administered and was 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 participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 32 43 45
Least Squares Mean (Standard Error)
Unit of Measure: Days
-3.64  (0.589) -4.26  (0.521) -4.34  (0.535)
15.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 24: RA Interference With Work Productivity
Hide Description 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 was interviewer-administered and was 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 is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 32 42 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.632  (0.4186) -2.422  (0.3719) -2.727  (0.3700)
16.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to RA
Hide Description 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 was interviewer-administered and was 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 participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 101 126 133
Least Squares Mean (Standard Error)
Unit of Measure: Days
-3.50  (0.590) -6.13  (0.551) -6.18  (0.537)
17.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by ≥ 50% Due to RA
Hide Description 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 was interviewer-administered and was 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 participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 101 125 133
Least Squares Mean (Standard Error)
Unit of Measure: Days
-3.36  (0.632) -4.60  (0.591) -4.88  (0.574)
18.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to RA
Hide Description 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 was interviewer-administered and was 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 participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 101 127 133
Least Squares Mean (Standard Error)
Unit of Measure: Days
-1.97  (0.479) -3.51  (0.446) -4.12  (0.435)
19.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to RA
Hide Description 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 was interviewer-administered and was 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 from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 101 126 133
Least Squares Mean (Standard Error)
Unit of Measure: Days
-1.60  (0.567) -3.87  (0.536) -3.86  (0.523)
20.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity
Hide Description 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 was interviewer-administered and was 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 from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 100 126 132
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.970  (0.2438) -3.096  (0.2238) -3.269  (0.2186)
21.Secondary Outcome
Title Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Scores at Week 24
Hide Description 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. Range of the final RAID value is 0-10 where 0= not affected, very good and 10 = most affected weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). A higher RAID value indicate worse status and lower indicate not affected. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline RAID as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = number of participants with RAID score assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 99 126 136
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.80  (0.203) -2.55  (0.189) -2.80  (0.183)
22.Secondary Outcome
Title Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) VAS Scores at Week 24
Hide Description The EQ-5D-3L is a standardized, generic measure of health outcome. It was designed for self-completion by participants. It was specifically included to address concerns regarding the health economic impact of RA. The EQ-5D-3L comprises 5 questions on mobility, self-care, pain, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems) and a vertical VAS that allows the participants to indicate their health state today that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline EQ-5D-3L Scores as a covariate.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = number of participants with EQ-5D-3L score assessment at both baseline and Week 24.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 96 126 133
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
14.85  (2.098) 20.06  (1.891) 18.40  (1.842)
23.Secondary Outcome
Title Percentage of Participants Achieving ACR20, ACR50 and ACR70 Criteria at Week 12
Hide Description ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR20 is 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 of the ACR. 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. ACR70 is 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 of the ACR.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 181 181 184
Measure Type: Number
Unit of Measure: Percentage of participants
ACR20 37.6 54.1 62.5
ACR50 13.3 30.4 33.2
ACR70 2.2 13.8 14.7
24.Secondary Outcome
Title Change From Baseline in DAS28-CRP at Week 12
Hide Description DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR rheumatoid arthritis core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline DAS score as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = number of participants with DAS28-CRP- Score assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 168 163 169
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.97  (0.104) -2.13  (0.105) -2.45  (0.103)
25.Secondary Outcome
Title Percentage of Participants Achieving Clinical Remission Score (DAS28--CRP <2.6) at Week 12
Hide Description DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH 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 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 181 181 184
Measure Type: Number
Unit of Measure: Percentage of participants
3.9 17.1 17.9
26.Secondary Outcome
Title Change From Baseline in SF-36 at Week 12
Hide Description SF-36 is a generic 36-item questionnaire measuring HRQL covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 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 subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline SF-36 as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed=participants with SF-36 assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 169 160 165
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Physical Component Summary Score at Week 12 3.74  (0.582) 6.93  (0.596) 6.84  (0.584)
Mental Component Summary Score at Week 12 3.50  (0.738) 5.14  (0.758) 6.47  (0.741)
27.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 12: Work Days Missed Due to RA
Hide Description 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 was interviewer-administered and was 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 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed=participants with WPS-RA individual items assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 54 54 56
Least Squares Mean (Standard Error)
Unit of Measure: Days
-1.20  (0.581) -1.97  (0.571) -2.98  (0.585)
28.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 12: Days With Work Productivity Reduced by ≥ 50% Due to RA
Hide Description 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 was interviewer-administered and was 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 participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 54 54 56
Least Squares Mean (Standard Error)
Unit of Measure: Days
-1.69  (0.784) -4.24  (0.773) -3.20  (0.785)
29.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 12: RA Interference With Work Productivity
Hide Description 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 was interviewer-administered and was 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 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 53 54 56
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.043  (0.3803) -1.924  (0.3742) -1.873  (0.3764)
30.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 12: House Work Days Missed Due to RA
Hide Description 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 was interviewer-administered and was 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 participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 170 164 169
Least Squares Mean (Standard Error)
Unit of Measure: Days
-2.10  (0.551) -5.52  (0.563) -5.54  (0.553)
31.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 12: Days With Household Work Productivity Reduced by ≥ 50% Due to RA
Hide Description 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 was interviewer-administered and was 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 participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 169 163 169
Least Squares Mean (Standard Error)
Unit of Measure: Days
-2.60  (0.576) -3.97  (0.587) -3.98  (0.575)
32.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 12: Days With Family/Social/Leisure Activities Missed Due to RA
Hide Description 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 was interviewer-administered and was 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 participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 170 164 169
Least Squares Mean (Standard Error)
Unit of Measure: Days
-2.23  (0.433) -2.53  (0.442) -3.26  (0.434)
33.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 12: Days With Outside Help Hired Due to RA
Hide Description 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 was interviewer-administered and was 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 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 170 164 169
Least Squares Mean (Standard Error)
Unit of Measure: Days
-0.77  (0.558) -3.07  (0.570) -2.94  (0.560)
34.Secondary Outcome
Title Change From Baseline in WPS-RA at Week 12: RA Interference With Household Work Productivity
Hide Description 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 was interviewer-administered and was 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 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 169 164 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.210  (0.2428) -2.772  (0.2474) -2.404  (0.2443)
35.Secondary Outcome
Title Change From Baseline in the FACIT-fatigue at Week 12
Hide Description The FACIT-Fatigue 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 ranging from 0 to 52. A higher score corresponded to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline FACIT-fatigue as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of Participants analyzed = number of participants with FACIT-fatigue score assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 169 165 172
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.56  (0.721) 8.02  (0.729) 9.45  (0.714)
36.Secondary Outcome
Title Change From Baseline in EQ-5D-3L VAS Scores at Week 12
Hide Description The EQ-5D-3L is a standardized, generic measure of health outcome. EQ-5D was designed for self-completion by participants. The EQ-5D was specifically included to address concerns regarding the health economic impact of RA. The EQ-5D-3L comprises 5 questions on mobility, self-care, pain, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems) and a vertical VAS that allows the participants to indicate their health state today that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline EQ-5D-3L scores as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = number of participants with EQ-5D-3L score assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 167 163 171
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
8.39  (1.699) 17.16  (1.720) 15.23  (1.680)
37.Secondary Outcome
Title Change From Baseline in RAID Scores at Week 12
Hide Description RAID score 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 NRS questions. Range of the final RAID value is 0-10 where 0= not affected, very good and 10 = most affected weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). A higher RAID value indicates worse status and lower indicates not affected. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline RAID scores as a covariate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = number of participants with RAID score assessment at both baseline and Week 12.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 167 162 171
Mean (Standard Error)
Unit of Measure: units on a scale
-1.34  (0.163) -2.27  (0.165) -2.47  (0.161)
38.Secondary Outcome
Title Change From Baseline in Individual ACR Components - TJC and SJC at Week 12 and Week 24
Hide Description ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS,HAQ-DI & CRP. 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 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number analyzed = number of participants with TJC and SJC assessments at both baseline and specified time points.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 181 181 184
Least Squares Mean (Standard Error)
Unit of Measure: joints
TJC at week 12 Number Analyzed 172 participants 165 participants 172 participants
-8.55  (0.959) -13.74  (0.975) -14.87  (0.954)
SJC at week 12 Number Analyzed 172 participants 165 participants 172 participants
-6.75  (0.687) -10.54  (0.698) -10.59  (0.684)
TJC at week 24 Number Analyzed 101 participants 127 participants 137 participants
-10.55  (1.060) -14.44  (1.017) -16.95  (0.992)
SJC at week 24 Number Analyzed 101 participants 127 participants 137 participants
-8.19  (0.721) -11.56  (0.691) -11.94  (0.674)
39.Secondary Outcome
Title Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 12 and Week 24
Hide Description ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & CRP. Physician global VAS & participant global VAS was done by 100 mm non-anchored VAS, from no arthritis (0) activity to maximal arthritis (100) activity. Pain VAS by 100 mm VAS ranging from 0 "no pain" to 100 "worst pain". LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number analyzed = number of participants with individual ACR components assessment at both baseline and specified time points.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 181 181 184
Least Squares Mean (Standard Error)
Unit of Measure: mm
Physician global VAS at week 12 Number Analyzed 172 participants 165 participants 171 participants
-22.74  (1.744) -33.64  (1.775) -35.44  (1.740)
Participant global VAS at week 12 Number Analyzed 172 participants 165 participants 171 participants
-13.75  (1.807) -25.28  (1.836) -27.38  (1.803)
Pain VAS at week 12 Number Analyzed 171 participants 166 participants 171 participants
-15.13  (1.908) -26.93  (1.933) -30.56  (1.901)
Physician global VAS at week 24 Number Analyzed 101 participants 127 participants 137 participants
-28.55  (1.806) -40.65  (1.695) -43.22  (1.646)
Participant global VAS at week 24 Number Analyzed 100 participants 127 participants 136 participants
-19.76  (2.171) -29.59  (2.046) -31.28  (1.997)
Pain VAS at week 24 Number Analyzed 98 participants 127 participants 135 participants
-21.27  (2.250) -31.90  (2.086) -33.65  (2.037)
40.Secondary Outcome
Title Change From Baseline in Individual ACR Component - CRP Level at Week 12 and Week 24
Hide Description ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & CRP. An elevated CRP level was considered a non-specific "marker" for RA. A reduction level indicates improvement. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number analyzed = number of participants with CRP assessment at both baseline and specified time points.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 181 181 184
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
CRP at week 12 Number Analyzed 168 participants 165 participants 170 participants
-3.63  (1.436) -15.08  (1.452) -22.98  (1.432)
CRP at week 24 Number Analyzed 100 participants 126 participants 137 participants
-3.60  (1.556) -15.24  (1.457) -23.27  (1.421)
41.Secondary Outcome
Title Change From Baseline in Individual ACR Component - HAQ-DI at Week 12 and Week 24
Hide Description ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS,HAQ-DI & CRP. HAQ-DI consisted of at least 2 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 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number analyzed = number of participants with HAQ-DI assessment at both baseline and specified time points.
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description:
Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
Overall Number of Participants Analyzed 181 181 184
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
HAQ-DI at week 12 Number Analyzed 170 participants 165 participants 171 participants
-0.26  (0.043) -0.46  (0.044) -0.47  (0.043)
HAQ-DI at week 24 Number Analyzed 101 participants 127 participants 136 participants
-0.34  (0.051) -0.52  (0.049) -0.58  (0.048)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on treatment period' (time from the first dose injection of study drug to the end of follow-up period). Safety population included all participants from the randomized population who received at least 1 dose or part of a dose of study drug.
 
Arm/Group Title Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Hide Arm/Group Description Placebo matched to sarilumab SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Sarilumab 150 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks. Sarilumab 200 mg SC injection q2w was added to one or a combination of the nonbiologic DMARD for 24 weeks.
All-Cause Mortality
Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/181 (3.31%)   6/181 (3.31%)   10/184 (5.43%) 
Blood and lymphatic system disorders       
Anaemia  1  1/181 (0.55%)  0/181 (0.00%)  0/184 (0.00%) 
Neutropenia  1  0/181 (0.00%)  1/181 (0.55%)  1/184 (0.54%) 
Cardiac disorders       
Acute myocardial infarction  1  0/181 (0.00%)  0/181 (0.00%)  1/184 (0.54%) 
Atrioventricular block second degree  1  0/181 (0.00%)  0/181 (0.00%)  1/184 (0.54%) 
Endocarditis noninfective  1  0/181 (0.00%)  0/181 (0.00%)  1/184 (0.54%) 
Gastrointestinal disorders       
Gastric ulcer haemorrhage  1  0/181 (0.00%)  1/181 (0.55%)  0/184 (0.00%) 
Inguinal hernia  1  0/181 (0.00%)  0/181 (0.00%)  1/184 (0.54%) 
Hepatobiliary disorders       
Mixed liver injury  1  1/181 (0.55%)  0/181 (0.00%)  0/184 (0.00%) 
Infections and infestations       
Bacteraemia  1  1/181 (0.55%)  0/181 (0.00%)  0/184 (0.00%) 
Bronchitis  1  1/181 (0.55%)  0/181 (0.00%)  0/184 (0.00%) 
Cellulitis  1  1/181 (0.55%)  1/181 (0.55%)  1/184 (0.54%) 
Osteomyelitis  1  0/181 (0.00%)  1/181 (0.55%)  0/184 (0.00%) 
Pneumonia  1  0/181 (0.00%)  0/181 (0.00%)  1/184 (0.54%) 
Injury, poisoning and procedural complications       
Ankle fracture  1  1/181 (0.55%)  0/181 (0.00%)  0/184 (0.00%) 
Post procedural haemorrhage  1  0/181 (0.00%)  0/181 (0.00%)  1/184 (0.54%) 
Road traffic accident  1  1/181 (0.55%)  0/181 (0.00%)  0/184 (0.00%) 
Investigations       
Neutrophil count decreased  1  0/181 (0.00%)  0/181 (0.00%)  1/184 (0.54%) 
Transaminases increased  1  0/181 (0.00%)  0/181 (0.00%)  1/184 (0.54%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc disorder  1  0/181 (0.00%)  0/181 (0.00%)  1/184 (0.54%) 
Intervertebral disc protrusion  1  0/181 (0.00%)  1/181 (0.55%)  0/184 (0.00%) 
Rheumatoid arthritis  1  1/181 (0.55%)  0/181 (0.00%)  0/184 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Ureteric cancer  1  1/181 (0.55%)  0/181 (0.00%)  0/184 (0.00%) 
Nervous system disorders       
Ischaemic stroke  1  0/181 (0.00%)  0/181 (0.00%)  1/184 (0.54%) 
Syncope  1  0/181 (0.00%)  1/181 (0.55%)  0/184 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  0/181 (0.00%)  1/181 (0.55%)  0/184 (0.00%) 
Vascular disorders       
Venous thrombosis limb  1  0/181 (0.00%)  0/181 (0.00%)  1/184 (0.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo q2w Sarilumab 150 mg q2w Sarilumab 200 mg q2w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/181 (14.36%)   60/181 (33.15%)   57/184 (30.98%) 
Blood and lymphatic system disorders       
Neutropenia  1  2/181 (1.10%)  23/181 (12.71%)  22/184 (11.96%) 
General disorders       
Injection site erythema  1  0/181 (0.00%)  11/181 (6.08%)  7/184 (3.80%) 
Infections and infestations       
Nasopharyngitis  1  9/181 (4.97%)  11/181 (6.08%)  7/184 (3.80%) 
Urinary tract infection  1  12/181 (6.63%)  6/181 (3.31%)  13/184 (7.07%) 
Investigations       
Alanine aminotransferase increased  1  2/181 (1.10%)  5/181 (2.76%)  10/184 (5.43%) 
Metabolism and nutrition disorders       
Hypertriglyceridaemia  1  3/181 (1.66%)  11/181 (6.08%)  5/184 (2.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-US@sanofi.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01709578    
Other Study ID Numbers: EFC10832
U1111-1115-8466 ( Other Identifier: UTN )
2011-003538-16 ( EudraCT Number )
First Submitted: October 15, 2012
First Posted: October 18, 2012
Results First Submitted: May 23, 2017
Results First Posted: August 8, 2017
Last Update Posted: August 8, 2017