An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).

Secondary Objectives:

To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX.

To assess the quality of life of participants with RA taking sarilumab in combination with MTX.

To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Adalimumab; Etanercept; Methotrexate

Criteria

Inclusion criteria:

• Diagnosis of RA >/= 3 months duration.

• Continuous treatment of MTX 10 - 25 mg/week (or per local labeling requirements if the dose range differs) for at least 12 weeks before screening visit and on a stable dose for 8 weeks before screening visit.

• Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high sensitivity C-reactive protein > 10 mg/L.

Exclusion criteria:

• Age < 18 years.

• Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks of the screening visit.

• Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks of the screening visit.

• Prior treatment with a tumor necrosis factor (TNF)-alpha inhibitor, or other biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.

• New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors within 4 weeks of the screening visit.

• Treatment with traditional oral DMARD /immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the screening visit, depending on DMARD.

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