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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01764997

Run by

Sanofi

People needed

776

Starts

2013-04-01

Expected to finish

2015-01-01

Last updated by the study team

2017-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840212 — Glendale, California, United States
• Investigational Site Number 840211 — Thousand Oaks, California, United States
• Investigational Site Number 840049 — Upland, California, United States
• Investigational Site Number 840205 — Victorville, California, United States
• Investigational Site Number 840201 — Denver, Colorado, United States
• Investigational Site Number 840209 — Danbury, Connecticut, United States
• Investigational Site Number 840203 — Washington D.C., District of Columbia, United States
• Investigational Site Number 840210 — Clearwater, Florida, United States
• Investigational Site Number 840128 — Ormond Beach, Florida, United States
• Investigational Site Number 840063 — Palm Harbor, Florida, United States
• Investigational Site Number 840060 — Sarasota, Florida, United States
• Investigational Site Number 840207 — Tampa, Florida, United States
• Investigational Site Number 840018 — Idaho Falls, Idaho, United States
• Investigational Site Number 840213 — Indianapolis, Indiana, United States
• Investigational Site Number 840109 — Lake Charles, Louisiana, United States
• Investigational Site Number 840073 — Cumberland, Maryland, United States
• Investigational Site Number 840202 — Hagerstown, Maryland, United States
• Investigational Site Number 840204 — Battle Creek, Michigan, United States
• Investigational Site Number 840150 — Lansing, Michigan, United States
• Investigational Site Number 840200 — Jackson, Mississippi, United States
• Investigational Site Number 840037 — Tupelo, Mississippi, United States
• Investigational Site Number 840112 — Lincoln, Nebraska, United States
• Investigational Site Number 840056 — New York, New York, United States
• Investigational Site Number 840117 — Pittsburgh, Pennsylvania, United States
• Investigational Site Number 840004 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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