A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agents
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-jRCT2080221561
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Presence of RA classified by American College of Rheumatology (ACR) 2010 revised criteria for at least 3 months before screening
-Patients must have been taking at least one anti-TNF-alpha agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-alpha agent
-Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician RA patients functional status class IV according to the ACR 1991 revised criteria
-Patients who have ever received biologic immunomodulating agents except for those targeting TNF-alpha
- Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy (proportion of patients achieving an ACR20 response) at 75 mg or 150 mg of secukinumab compared to placebo as add-on therapy in patients with active RA despite stable treatment with methotrexate (MTX) [ Time Frame: Week 24 ]
- Secondary Outcome Measures
Name Time Method