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

• Conditions: Rheumatoid Arthritis; MedDRA version: 15.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-001984-66-CZ
• Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-27
• Last Update Posted: 23 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5910

Inclusion Criteria

Diagnosis of rheumatoid arthritis (RA) >/= 3 months duration.
Continuous treatment of methotrexate (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.

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 2060
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 540

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 TNF (tumor necrosis factor)-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 inhibitors (COX-2 inhibitors within 4 weeks of the screening visit.
Treatment with traditional oral disease-modifying antirheumatic drugs (DMARD) /immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the screening visit, depending on DMARD.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified