JPRN-jRCT2080221561
Unknown
Phase 3
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
ovartis Pharma K.K.0 sitesSeptember 5, 2011
ConditionsRheumatoid Arthritis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- ovartis Pharma K.K.
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\-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.
Outcomes
Primary Outcomes
Not specified
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