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)

Launched by SANOFI · Oct 16, 2012

Keywords

ClinConnect Summary

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).

Gender

ALL

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