To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• sarilumab SAR153191 (REGN88) — DRUG
  Pharmaceutical form: solution Route of administration: subcutaneous
• tocilizumab — DRUG
  Pharmaceutical form: solution Route of administration: intravenous
• hydroxychloroquine — DRUG
  Dispensed according to local practice.
• methotrexate — DRUG
  Dispensed according to local practice.
• sulfasalazine — DRUG
  Dispensed according to local practice.
• leflunomide — DRUG
  Dispensed according to local practice.
• subcutaneous placebo — DRUG
  Pharmaceutical form: solution Route of administration: subcutaneous
• intravenous placebo — DRUG
  Pharmaceutical form: solution Route of administration: intravenous

Study Details

Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

Key Dates

Start date

Mar 31, 2013

Status verified

Jun 2017

Primary completion

Oct 31, 2014

Completion

Oct 31, 2014

Study Design

Enrollment

202 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sarilumab 150 mg q2w
  Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD), hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.
• Experimental: Sarilumab 200 mg q2w
  Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.
• Active Comparator: Tocilizumab q4w
  Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 211 days ]

Locations (14)

Find similar trials in Huntsville, AL

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