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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)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Sarilumab

placebo

hydroxychloroquine

methotrexate

sulfasalazine

leflunomide

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Diagnosis of RA ≥6 months duration, according to the ACR /European League against Rheumatism (EULAR) 2010 RA Classification Criteria

ACR Class I-III functional status, based on 1991 revised criteria

Anti-TNF therapy failures, defined by the investigator as participants with an inadequate clinical response, after being treated for at least 3 consecutive months, and/or intolerance to at least 1 anti-TNF blocker(s), resulting in or requiring their discontinuation:

TNF-blockers included, but were not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab

Moderate-to-severely active RA

Continuous treatment with one or a combination of DMARDs (except for simultaneous combination use of leflunomide and methotrexate) for at least 12 weeks prior to baseline and on a stable dose(s) for at least 6 weeks prior to screening:

Methotrexate - 6 to 25 mg/week orally or parenterally
Leflunomide - 10 to 20 mg orally daily
Sulfasalazine - 1000 to 3000 mg orally daily
Hydroxychloroquine - 200 to 400 mg orally daily

Exclusion criteria:

Participants <18 years of age or legal adult age

Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA

History of juvenile idiopathic arthritis or arthritis onset prior to age 16

Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.

Treatment with anti-TNF agents, as follows:

Within 28 days prior to the baseline visit - etanercept
Within 42 days prior to the baseline visit - infliximab, adalimumab, golimumab, certolizumab pegol

Treatment with previous RA-directed biologic agents with other than TNF antagonist mechanisms:

Within 28 days prior to the randomization (baseline) visit - anakinra Within 42 days prior to the randomization (baseline) visit - abatacept

Within 6 months prior to the randomization (baseline) visit - any cell depleting agents including but not limited to rituximab without a normal lymphocyte and cluster of differentiation (CD) 19+ lymphocyte count

Treatment with any DMARD other than those allowed per protocol and limited to the maximum specified dosage within 12 weeks prior to baseline

Treatment with prednisone >10 mg or equivalent per day, or change in dosage within 4 weeks prior to baseline visit

Any parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline

Prior treatment with anti-interleukin (IL) -6 or IL-6 receptor antagonist therapies, including tocilizumab or sarilumab, participation in a prior study of sarilumab, irrespective of treatment arm

Prior treatment with a Janus kinase inhibitor (such as tofacitinib)

New treatment or dose-adjustment to ongoing medication for dyslipidemia within 6 weeks prior to randomization, ie, stable dose for at least 6 weeks prior to randomization

Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first investigational medicinal product (IMP) administration, whichever was longer

History of alcohol or drug abuse within 5 years prior to the screening visit

Participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization (baseline) visit. Nonmalignant lymphoproliferative disorders were also excluded

Participants with active tuberculosis or latent tuberculosis infection

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo q2w

Sarilumab 150 mg q2w

Sarilumab 200 mg q2w

Arm Description

Placebo matched to sarilumab once every 2 weeks (q2w) was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks.

Sarilumab 150 mg q2w was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks.

Sarilumab 200 mg q2w was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24

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.

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12

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.

Secondary Outcome Measures

Change From Baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 24

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.

Percentage of Participants Achieving ACR50 Criteria at Week 24

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.

Percentage of Participants Achieving ACR70 Criteria at Week 24

Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 24

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.

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24

CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: 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.

Change From Baseline in HAQ-DI at Week 24

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.

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Component Summary Scores (PCS) at Week 24

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.

Change From Baseline in SF-36 MCS at Week 24

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.

Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-fatigue) Score at Week 24

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.

Change From Baseline in Morning Stiffness VAS at Week 24

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

Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to RA

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.

Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to RA

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.

Change From Baseline in WPS-RA at Week 24: RA Interference With Work Productivity

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.

Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to RA

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.

Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by ≥ 50% Due to RA

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.

Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to RA

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.

Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to RA

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.

Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity

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.

Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Scores at Week 24

RAID is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well being, quality of sleep, and coping. The RAID is calculated based on 7 numerical rating scales (NRS) questions. 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.

Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) VAS Scores at Week 24

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.

Percentage of Participants Achieving ACR20, ACR50 and ACR70 Criteria at Week 12

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.

Change From Baseline in DAS28-CRP at Week 12

Percentage of Participants Achieving Clinical Remission Score (DAS28--CRP <2.6) at Week 12

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.

Change From Baseline in SF-36 at Week 12

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.

Change From Baseline in WPS-RA at Week 12: Work Days Missed Due to RA

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.

Change From Baseline in WPS-RA at Week 12: Days With Work Productivity Reduced by ≥ 50% Due to RA

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.

Change From Baseline in WPS-RA at Week 12: RA Interference With Work Productivity

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.

Change From Baseline in WPS-RA at Week 12: House Work Days Missed Due to RA

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.

Change From Baseline in WPS-RA at Week 12: Days With Household Work Productivity Reduced by ≥ 50% Due to RA

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.

Change From Baseline in WPS-RA at Week 12: Days With Family/Social/Leisure Activities Missed Due to RA

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.

Change From Baseline in WPS-RA at Week 12: Days With Outside Help Hired Due to RA

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.

Change From Baseline in WPS-RA at Week 12: RA Interference With Household Work Productivity

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.

Change From Baseline in the FACIT-fatigue at Week 12

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.

Change From Baseline in EQ-5D-3L VAS Scores at Week 12

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.

Change From Baseline in RAID Scores at Week 12

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.

Change From Baseline in Individual ACR Components - TJC and SJC at Week 12 and Week 24

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.

Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 12 and Week 24

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.

Change From Baseline in Individual ACR Component - CRP Level at Week 12 and Week 24

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.

Change From Baseline in Individual ACR Component - HAQ-DI at Week 12 and Week 24

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.

Full Information

NCT ID

NCT01709578

First Posted

October 15, 2012

Last Updated

July 7, 2017

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01709578

Brief Title

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)

Official Title

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-α Antagonists

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for: reduction of signs and symptoms at Week 24 and improvement of physical function at Week 12 in participants with active rheumatoid arthritis (RA) who were inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists. Secondary Objectives: The secondary objectives were to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in participants with active RA who were inadequate responders or intolerant to TNF-α antagonists, for: Reduction of signs and symptoms at Week 12; Improvement in physical function at Week 24; Improvement in disease activity score as measured by other American College of Rheumatology (ACR) derived components at Weeks 12 and 24; Improvement in quality of life as measured by participant reported outcomes (PROs) at intermediate visits and Week 24. To assess the exposure of sarilumab added to DMARD therapy in this population. To assess the safety of sarilumab in this population.

Detailed Description

Total study duration was up to 34 weeks: screening up to 28 days, treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks. After completion of the treatment phase of this study, participant were eligible to enter a long term safety study (LTS11210) for active treatment with SAR153191 (REGN88).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

546 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo q2w

Arm Type

Placebo Comparator

Arm Description

Arm Title

Sarilumab 150 mg q2w

Arm Type

Experimental

Arm Description

Arm Title

Sarilumab 200 mg q2w

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sarilumab

Other Intervention Name(s)

SAR153191, REGN88

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

hydroxychloroquine

Intervention Description

Dispensed according to the local practice.

Intervention Type

Drug

Intervention Name(s)

methotrexate

Intervention Description

Dispensed according to the local practice.

Intervention Type

Drug

Intervention Name(s)

sulfasalazine

Intervention Description

Dispensed according to the local practice.

Intervention Type

Drug

Intervention Name(s)

leflunomide

Intervention Description

Dispensed according to the local practice.

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24

Description

Time Frame

Week 24

Title

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 24

Description

Time Frame

Baseline, Week 24

Title

Percentage of Participants Achieving ACR50 Criteria at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants Achieving ACR70 Criteria at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 24

Description

Time Frame

Week 24

Title

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in HAQ-DI at Week 24

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

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Component Summary Scores (PCS) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in SF-36 MCS at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-fatigue) Score at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Morning Stiffness VAS at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to RA

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to RA

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

Title

Change From Baseline in WPS-RA at Week 24: RA Interference With Work Productivity

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

Title

Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to RA

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

Title

Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by ≥ 50% Due to RA

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

Title

Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to RA

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

Title

Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to RA

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

Title

Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity

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

Title

Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Scores at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) VAS Scores at Week 24

Description

Time Frame

Baseline, Week 24

Title

Percentage of Participants Achieving ACR20, ACR50 and ACR70 Criteria at Week 12

Description

Time Frame

Week 12

Title

Change From Baseline in DAS28-CRP at Week 12

Description

Time Frame

Baseline, Week 12

Title

Percentage of Participants Achieving Clinical Remission Score (DAS28--CRP <2.6) at Week 12

Description

Time Frame

Week 12

Title

Change From Baseline in SF-36 at Week 12

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

Title

Change From Baseline in WPS-RA at Week 12: Work Days Missed Due to RA

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

Title

Change From Baseline in WPS-RA at Week 12: Days With Work Productivity Reduced by ≥ 50% Due to RA

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

Title

Change From Baseline in WPS-RA at Week 12: RA Interference With Work Productivity

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

Title

Change From Baseline in WPS-RA at Week 12: House Work Days Missed Due to RA

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

Title

Change From Baseline in WPS-RA at Week 12: Days With Household Work Productivity Reduced by ≥ 50% Due to RA

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

Title

Change From Baseline in WPS-RA at Week 12: Days With Family/Social/Leisure Activities Missed Due to RA

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

Title

Change From Baseline in WPS-RA at Week 12: Days With Outside Help Hired Due to RA

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

Title

Change From Baseline in WPS-RA at Week 12: RA Interference With Household Work Productivity

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

Title

Change From Baseline in the FACIT-fatigue at Week 12

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

Title

Change From Baseline in EQ-5D-3L VAS Scores at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in RAID Scores at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Individual ACR Components - TJC and SJC at Week 12 and Week 24

Description

Time Frame

Baseline, Week 12 and Week 24

Title

Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 12 and Week 24

Description

Time Frame

Baseline, Week 12 and Week 24

Title

Change From Baseline in Individual ACR Component - CRP Level at Week 12 and Week 24

Description

Time Frame

Baseline, Week 12 and Week 24

Title

Change From Baseline in Individual ACR Component - HAQ-DI at Week 12 and Week 24

Description

Time Frame

Baseline, Week 12 and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Diagnosis of RA ≥6 months duration, according to the ACR /European League against Rheumatism (EULAR) 2010 RA Classification Criteria ACR Class I-III functional status, based on 1991 revised criteria Anti-TNF therapy failures, defined by the investigator as participants with an inadequate clinical response, after being treated for at least 3 consecutive months, and/or intolerance to at least 1 anti-TNF blocker(s), resulting in or requiring their discontinuation: TNF-blockers included, but were not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab Moderate-to-severely active RA Continuous treatment with one or a combination of DMARDs (except for simultaneous combination use of leflunomide and methotrexate) for at least 12 weeks prior to baseline and on a stable dose(s) for at least 6 weeks prior to screening: Methotrexate - 6 to 25 mg/week orally or parenterally Leflunomide - 10 to 20 mg orally daily Sulfasalazine - 1000 to 3000 mg orally daily Hydroxychloroquine - 200 to 400 mg orally daily Exclusion criteria: Participants <18 years of age or legal adult age Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA History of juvenile idiopathic arthritis or arthritis onset prior to age 16 Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome. Treatment with anti-TNF agents, as follows: Within 28 days prior to the baseline visit - etanercept Within 42 days prior to the baseline visit - infliximab, adalimumab, golimumab, certolizumab pegol Treatment with previous RA-directed biologic agents with other than TNF antagonist mechanisms: Within 28 days prior to the randomization (baseline) visit - anakinra Within 42 days prior to the randomization (baseline) visit - abatacept Within 6 months prior to the randomization (baseline) visit - any cell depleting agents including but not limited to rituximab without a normal lymphocyte and cluster of differentiation (CD) 19+ lymphocyte count Treatment with any DMARD other than those allowed per protocol and limited to the maximum specified dosage within 12 weeks prior to baseline Treatment with prednisone >10 mg or equivalent per day, or change in dosage within 4 weeks prior to baseline visit Any parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline Prior treatment with anti-interleukin (IL) -6 or IL-6 receptor antagonist therapies, including tocilizumab or sarilumab, participation in a prior study of sarilumab, irrespective of treatment arm Prior treatment with a Janus kinase inhibitor (such as tofacitinib) New treatment or dose-adjustment to ongoing medication for dyslipidemia within 6 weeks prior to randomization, ie, stable dose for at least 6 weeks prior to randomization Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first investigational medicinal product (IMP) administration, whichever was longer History of alcohol or drug abuse within 5 years prior to the screening visit Participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization (baseline) visit. Nonmalignant lymphoproliferative disorders were also excluded Participants with active tuberculosis or latent tuberculosis infection The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840070

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Investigational Site Number 840138

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Investigational Site Number 840142

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

Investigational Site Number 840134

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Investigational Site Number 840141

City

Glendale

State/Province

California

ZIP/Postal Code

85304

Country

United States

Facility Name

Investigational Site Number 840111

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Investigational Site Number 840135

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Investigational Site Number 840021

City

Santa Maria

State/Province

California

ZIP/Postal Code

94354

Country

United States

Facility Name

Investigational Site Number 840100

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Investigational Site Number 840049

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Investigational Site Number 840131

City

Whittier

State/Province

California

ZIP/Postal Code

90606

Country

United States

Facility Name

Investigational Site Number 840201

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Investigational Site Number 840130

City

Lewes

State/Province

Delaware

ZIP/Postal Code

19958

Country

United States

Facility Name

Investigational Site Number 840125

City

DeBary

State/Province

Florida

ZIP/Postal Code

32713

Country

United States

Facility Name

Investigational Site Number 840048

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Investigational Site Number 840024

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Investigational Site Number 840006

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Investigational Site Number 840128

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Investigational Site Number 840063

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Investigational Site Number 840060

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Investigational Site Number 840140

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Investigational Site Number 840126

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Investigational Site Number 840018

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Investigational Site Number 840110

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Investigational Site Number 840052

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160-7321

Country

United States

Facility Name

Investigational Site Number 840015

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Investigational Site Number 840120

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Investigational Site Number 840109

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Investigational Site Number 840055

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

Investigational Site Number 840150

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Investigational Site Number 840137

City

Saint Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

Investigational Site Number 840037

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

Investigational Site Number 840112

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Investigational Site Number 840106

City

Orchard Park

State/Province

New York

ZIP/Postal Code

14127

Country

United States

Facility Name

Investigational Site Number 840121

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Investigational Site Number 840115

City

Roslyn

State/Province

New York

ZIP/Postal Code

11576

Country

United States

Facility Name

Investigational Site Number 840118

City

Smithtown

State/Province

New York

ZIP/Postal Code

11787

Country

United States

Facility Name

Investigational Site Number 840139

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Investigational Site Number 840123

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Investigational Site Number 840116

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Investigational Site Number 840127

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Investigational Site Number 840011

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74104

Country

United States

Facility Name

Investigational Site Number 840009

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Investigational Site Number 840117

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Investigational Site Number 840062

City

Reading

State/Province

Pennsylvania

ZIP/Postal Code

19611

Country

United States

Facility Name

Investigational Site Number 840058

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Investigational Site Number 840025

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Investigational Site Number 840059

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Investigational Site Number 840132

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Investigational Site Number 840022

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Investigational Site Number 840114

City

El Paso

State/Province

Texas

ZIP/Postal Code

79902

Country

United States

Facility Name

Investigational Site Number 840133

City

Houston

State/Province

Texas

ZIP/Postal Code

77008

Country

United States

Facility Name

Investigational Site Number 840129

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Investigational Site Number 840074

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Investigational Site Number 840036

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Investigational Site Number 840124

City

Clarksburg

State/Province

West Virginia

ZIP/Postal Code

26301

Country

United States

Facility Name

Investigational Site Number 032015

City

Buenos Aires

ZIP/Postal Code

32015

Country

Argentina

Facility Name

Investigational Site Number 032008

City

Buenos Aires

ZIP/Postal Code

C1428DZF

Country

Argentina

Facility Name

Investigational Site Number 032019

City

Caba

ZIP/Postal Code

1180

Country

Argentina

Facility Name

Investigational Site Number 032006

City

Caba

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

Investigational Site Number 032016

City

Capital Federal

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Investigational Site Number 032020

City

Cordoba

ZIP/Postal Code

X5119XAA

Country

Argentina

Facility Name

Investigational Site Number 032017

City

La Plata

Country

Argentina

Facility Name

Investigational Site Number 032010

City

Ramos Mejia

ZIP/Postal Code

B1704ETD

Country

Argentina

Facility Name

Investigational Site Number 032013

City

Rosario

ZIP/Postal Code

S2000PBJ

Country

Argentina

Facility Name

Investigational Site Number 032004

City

San Miguel De Tucuman

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

Investigational Site Number 032009

City

Zarate

ZIP/Postal Code

B2800DGH

Country

Argentina

Facility Name

Investigational Site Number 036014

City

Victoria Park

ZIP/Postal Code

6100

Country

Australia

Facility Name

Investigational Site Number 040004

City

Stockerau

ZIP/Postal Code

2000

Country

Austria

Facility Name

Investigational Site Number 040003

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Investigational Site Number 076001

City

Curitiba

ZIP/Postal Code

80060-240

Country

Brazil

Facility Name

Investigational Site Number 076016

City

Curitiba

Country

Brazil

Facility Name

Investigational Site Number 076006

City

Goiania

ZIP/Postal Code

74110-120

Country

Brazil

Facility Name

Investigational Site Number 076010

City

Juiz De Fora

ZIP/Postal Code

36010-570

Country

Brazil

Facility Name

Investigational Site Number 076005

City

Rio De Janeiro

ZIP/Postal Code

20551-030

Country

Brazil

Facility Name

Investigational Site Number 076015

City

Rio De Janeiro

ZIP/Postal Code

22271-100

Country

Brazil

Facility Name

Investigational Site Number 124005

City

Toronto

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Investigational Site Number 124009

City

Trois-Rivières

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Investigational Site Number 124104

City

Victoria

ZIP/Postal Code

V8V 3P9

Country

Canada

Facility Name

Investigational Site Number 152015

City

Temuco

Country

Chile

Facility Name

Investigational Site Number 170001

City

Bogota

Country

Colombia

Facility Name

Investigational Site Number 170012

City

Bogota

Country

Colombia

Facility Name

Investigational Site Number 170006

City

Bogotá

Country

Colombia

Facility Name

Investigational Site Number 170007

City

Bucaramanga

Country

Colombia

Facility Name

Investigational Site Number 170009

City

Bucaramanga

Country

Colombia

Facility Name

Investigational Site Number 170014

City

Chia

Country

Colombia

Facility Name

Investigational Site Number 170019

City

Medellin

Country

Colombia

Facility Name

Investigational Site Number 203008

City

Hostivice

ZIP/Postal Code

233 01

Country

Czechia

Facility Name

Investigational Site Number 203004

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

Investigational Site Number 203007

City

Praha 2

ZIP/Postal Code

12850

Country

Czechia

Facility Name

Investigational Site Number 203002

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

Investigational Site Number 203006

City

Zlin

ZIP/Postal Code

76001

Country

Czechia

Facility Name

Investigational Site Number 218003

City

Cuenca

Country

Ecuador

Facility Name

Investigational Site Number 218001

City

Guayaquil

ZIP/Postal Code

0593

Country

Ecuador

Facility Name

Investigational Site Number 218002

City

Quito

ZIP/Postal Code

0593

Country

Ecuador

Facility Name

Investigational Site Number 276011

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Investigational Site Number 276010

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Investigational Site Number 276001

City

Berlin

ZIP/Postal Code

12305

Country

Germany

Facility Name

Investigational Site Number 276014

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Investigational Site Number 276018

City

Deggingen

ZIP/Postal Code

73326

Country

Germany

Facility Name

Investigational Site Number 276004

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Investigational Site Number 276015

City

Halle/Saale

ZIP/Postal Code

06108

Country

Germany

Facility Name

Investigational Site Number 276013

City

Hamburg

ZIP/Postal Code

22147

Country

Germany

Facility Name

Investigational Site Number 276016

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Investigational Site Number 276017

City

München

ZIP/Postal Code

80336

Country

Germany

Facility Name

Investigational Site Number 276021

City

Osnabrück

ZIP/Postal Code

49074

Country

Germany

Facility Name

Investigational Site Number 276020

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Investigational Site Number 276019

City

Zerbst

ZIP/Postal Code

39261

Country

Germany

Facility Name

Investigational Site Number 300002

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

Investigational Site Number 300005

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Investigational Site Number 320002

City

Guatemala City

ZIP/Postal Code

01009

Country

Guatemala

Facility Name

Investigational Site Number 320003

City

Guatemala City

ZIP/Postal Code

01011

Country

Guatemala

Facility Name

Investigational Site Number 320001

City

Guatemala City

ZIP/Postal Code

09090

Country

Guatemala

Facility Name

Investigational Site Number 348022

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Investigational Site Number 348003

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Investigational Site Number 348004

City

Veszprém

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Investigational Site Number 348017

City

Veszprém

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Investigational Site Number 376001

City

Haifa

ZIP/Postal Code

31048

Country

Israel

Facility Name

Investigational Site Number 376003

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Investigational Site Number 376002

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Investigational Site Number 380011

City

Catania

ZIP/Postal Code

95122

Country

Italy

Facility Name

Investigational Site Number 380002

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

Investigational Site Number 380005

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Investigational Site Number 380014

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

Investigational Site Number 380013

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

Investigational Site Number 410017

City

Daejeon

ZIP/Postal Code

301-721

Country

Korea, Republic of

Facility Name

Investigational Site Number 410016

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Investigational Site Number 440005

City

Kaunas

ZIP/Postal Code

LT-50009

Country

Lithuania

Facility Name

Investigational Site Number 440006

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

Investigational Site Number 440007

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Investigational Site Number 484023

City

Chihuahua

ZIP/Postal Code

31020

Country

Mexico

Facility Name

Investigational Site Number 484018

City

Guadalajara

ZIP/Postal Code

44620

Country

Mexico

Facility Name

Investigational Site Number 484002

City

Guadalajara

ZIP/Postal Code

44690

Country

Mexico

Facility Name

Investigational Site Number 484024

City

Guadalajara

Country

Mexico

Facility Name

Investigational Site Number 484010

City

Mexicali

ZIP/Postal Code

21200

Country

Mexico

Facility Name

Investigational Site Number 484019

City

Monterrey

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Investigational Site Number 484020

City

Monterrey

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Investigational Site Number 484005

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Investigational Site Number 484017

City

México

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Investigational Site Number 484021

City

Queretaro

ZIP/Postal Code

76178

Country

Mexico

Facility Name

Investigational Site Number 554005

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

Investigational Site Number 554011

City

Nelson

ZIP/Postal Code

7010

Country

New Zealand

Facility Name

Investigational Site Number 554007

City

Otahuhu

ZIP/Postal Code

2025

Country

New Zealand

Facility Name

Investigational Site Number 554001

City

Timaru

ZIP/Postal Code

7910

Country

New Zealand

Facility Name

Investigational Site Number 554006

City

Wellington

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

Investigational Site Number 604010

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Investigational Site Number 604009

City

Lima

ZIP/Postal Code

LIMA 01

Country

Peru

Facility Name

Investigational Site Number 604006

City

Lima

ZIP/Postal Code

LIMA 11

Country

Peru

Facility Name

Investigational Site Number 604012

City

Lima

ZIP/Postal Code

LIMA 11

Country

Peru

Facility Name

Investigational Site Number 604013

City

Lima

ZIP/Postal Code

LIMA 13

Country

Peru

Facility Name

Investigational Site Number 604001

City

Lima

ZIP/Postal Code

Lima 21

Country

Peru

Facility Name

Investigational Site Number 604008

City

Lima

ZIP/Postal Code

LIMA 27

Country

Peru

Facility Name

Investigational Site Number 604007

City

Lima

ZIP/Postal Code

Lima 33

Country

Peru

Facility Name

Investigational Site Number 604005

City

Lima

ZIP/Postal Code

LIMA 41

Country

Peru

Facility Name

Investigational Site Number 604014

City

Lima

ZIP/Postal Code

LIMA 41

Country

Peru

Facility Name

Investigational Site Number 616014

City

Bialystok

ZIP/Postal Code

15-099

Country

Poland

Facility Name

Investigational Site Number 616019

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Investigational Site Number 616015

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Investigational Site Number 616018

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

Investigational Site Number 616016

City

Szczecin

ZIP/Postal Code

71-252

Country

Poland

Facility Name

Investigational Site Number 616004

City

Warszawa

ZIP/Postal Code

02-118

Country

Poland

Facility Name

Investigational Site Number 616017

City

Warszawa

ZIP/Postal Code

02-653

Country

Poland

Facility Name

Investigational Site Number 616020

City

Wroclaw

ZIP/Postal Code

50-556

Country

Poland

Facility Name

Investigational Site Number 620002

City

Lisboa

ZIP/Postal Code

1050-034

Country

Portugal

Facility Name

Investigational Site Number 620004

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Investigational Site Number 620007

City

Ponte De Lima

Country

Portugal

Facility Name

Investigational Site Number 642001

City

Bucuresti

ZIP/Postal Code

010976

Country

Romania

Facility Name

Investigational Site Number 642012

City

Bucuresti

ZIP/Postal Code

020475

Country

Romania

Facility Name

Investigational Site Number 642002

City

Bucuresti

ZIP/Postal Code

020983

Country

Romania

Facility Name

Investigational Site Number 642014

City

Iasi

ZIP/Postal Code

700661

Country

Romania

Facility Name

Investigational Site Number 643001

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Investigational Site Number 643021

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Investigational Site Number 643022

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Investigational Site Number 643008

City

Saint-Petersburg

ZIP/Postal Code

192242

Country

Russian Federation

Facility Name

Investigational Site Number 643010

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

Investigational Site Number 703001

City

Kosice

ZIP/Postal Code

040 11

Country

Slovakia

Facility Name

Investigational Site Number 724016

City

Barakaldo

ZIP/Postal Code

48903

Country

Spain

Facility Name

Investigational Site Number 724015

City

Barcelona

ZIP/Postal Code

08034

Country

Spain

Facility Name

Investigational Site Number 724014

City

Cadiz

ZIP/Postal Code

1009

Country

Spain

Facility Name

Investigational Site Number 724009

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Investigational Site Number 724001

City

Málaga

ZIP/Postal Code

29009

Country

Spain

Facility Name

Investigational Site Number 724011

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Investigational Site Number 724017

City

Santiago De Compostela

ZIP/Postal Code

15702

Country

Spain

Facility Name

Investigational Site Number 724013

City

Santiago De Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Investigational Site Number 724007

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Investigational Site Number 158005

City

Kaohsiung

ZIP/Postal Code

81346

Country

Taiwan

Facility Name

Investigational Site Number 158006

City

Taipei

ZIP/Postal Code

402

Country

Taiwan

Facility Name

Investigational Site Number 158002

City

Taoyuan County

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Investigational Site Number 792007

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

Investigational Site Number 792008

City

Gaziantep

ZIP/Postal Code

27310

Country

Turkey

Facility Name

Investigational Site Number 792009

City

Samsun

Country

Turkey

Facility Name

Investigational Site Number 804013

City

Kharkiv

ZIP/Postal Code

61176

Country

Ukraine

Facility Name

Investigational Site Number 804014

City

Kyiv

ZIP/Postal Code

01103

Country

Ukraine

Facility Name

Investigational Site Number 804027

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804011

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Investigational Site Number 804009

City

Zaporizhzhya

ZIP/Postal Code

69600

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

27860410

Citation

Fleischmann R, van Adelsberg J, Lin Y, Castelar-Pinheiro GD, Brzezicki J, Hrycaj P, Graham NM, van Hoogstraten H, Bauer D, Burmester GR. Sarilumab and Nonbiologic Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Tumor Necrosis Factor Inhibitors. Arthritis Rheumatol. 2017 Feb;69(2):277-290. doi: 10.1002/art.39944.

Results Reference

result

PubMed Identifier

36008838

Citation

Rubbert-Roth A, Furst DE, Fiore S, Praestgaard A, Bykerk V, Bingham CO, Charles-Schoeman C, Burmester G. Association between low hemoglobin, clinical measures, and patient-reported outcomes in patients with rheumatoid arthritis: results from post hoc analyses of three phase III trials of sarilumab. Arthritis Res Ther. 2022 Aug 25;24(1):207. doi: 10.1186/s13075-022-02891-x.

Results Reference

derived

PubMed Identifier

34519964

Citation

Rehberg M, Giegerich C, Praestgaard A, van Hoogstraten H, Iglesias-Rodriguez M, Curtis JR, Gottenberg JE, Schwarting A, Castaneda S, Rubbert-Roth A, Choy EHS; MOBILITY, MONARCH, TARGET, and ASCERTAIN investigators. Identification of a Rule to Predict Response to Sarilumab in Patients with Rheumatoid Arthritis Using Machine Learning and Clinical Trial Data. Rheumatol Ther. 2021 Dec;8(4):1661-1675. doi: 10.1007/s40744-021-00361-5. Epub 2021 Sep 14. Erratum In: Rheumatol Ther. 2021 Oct 29;:

Results Reference

derived

PubMed Identifier

33871596

Citation

Fleischmann R, Genovese MC, Maslova K, Leher H, Praestgaard A, Burmester GR. Long-term safety and efficacy of sarilumab over 5 years in patients with rheumatoid arthritis refractory to TNF inhibitors. Rheumatology (Oxford). 2021 Nov 3;60(11):4991-5001. doi: 10.1093/rheumatology/keab355.

Results Reference

derived

PubMed Identifier

32907617

Citation

Genovese MC, Burmester GR, Hagino O, Thangavelu K, Iglesias-Rodriguez M, John GS, Gonzalez-Gay MA, Mandrup-Poulsen T, Fleischmann R. Interleukin-6 receptor blockade or TNFalpha inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials. Arthritis Res Ther. 2020 Sep 9;22(1):206. doi: 10.1186/s13075-020-02229-5.

Results Reference

derived

PubMed Identifier

32522251

Citation

Genovese MC, Fleischmann R, Kivitz A, Lee EB, van Hoogstraten H, Kimura T, St John G, Mangan EK, Burmester GR. Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies. Arthritis Res Ther. 2020 Jun 10;22(1):139. doi: 10.1186/s13075-020-02194-z.

Results Reference

derived

PubMed Identifier

30877216

Citation

Gossec L, Strand V, Proudfoot C, Chen CI, Guillonneau S, Kimura T, van Hoogstraten H, Mangan E, Reaney M. Effects of Sarilumab on Rheumatoid Arthritis as Reported by Patients Using the Rheumatoid Arthritis Impact of Disease Scale. J Rheumatol. 2019 Oct;46(10):1259-1267. doi: 10.3899/jrheum.180904. Epub 2019 Mar 15.

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PubMed Identifier

29556418

Citation

Gabay C, Msihid J, Zilberstein M, Paccard C, Lin Y, Graham NMH, Boyapati A. Identification of sarilumab pharmacodynamic and predictive markers in patients with inadequate response to TNF inhibition: a biomarker substudy of the phase 3 TARGET study. RMD Open. 2018 Mar 14;4(1):e000607. doi: 10.1136/rmdopen-2017-000607. eCollection 2018.

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PubMed Identifier

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Citation

Strand V, Reaney M, Chen CI, Proudfoot CW, Guillonneau S, Bauer D, Mangan E, Graham NM, van Hoogstraten H, Lin Y, Pacheco-Tena C, Fleischmann R. Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients with inadequate response/intolerance to tumour necrosis factor inhibitors. RMD Open. 2017 Mar 7;3(1):e000416. doi: 10.1136/rmdopen-2016-000416. eCollection 2017.

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Learn more about this trial

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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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)

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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