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)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 546

Inclusion Criteria

Diagnosis of rheumatoid arthritis ?6 months duration, according to the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria
ACR Class I-III functional status, based on 1991 revised criteria
Anti-TNF therapy failures, defined by the investigator as patients 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 may include, but are not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab.
Moderate-to-severely active rheumatoid arthritis.
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/wk orally or intramuscular
Leflunomide ? 10 to 20 mg orally daily
Sulfasalazine ? 1000 to 3000 mg orally daily.
Hydroxychloroquine - 200 to 400 mg orally daily.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122

Exclusion Criteria

Patients <18 years of 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 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-IL-6 or IL-6R 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 statin medication 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 is longer.
History of alcohol or drug abuse within 5 years prior to the screening visit.
Patients 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 are also excluded.
Patients with active tuberculosis or latent tuberculosis infection.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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