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-TNFα agents(AIN457).
The purpose of this study is to demonstrate at Week 24 the efficacy and assess the safety of secukinumab given as intravenous (i.v.) loading doses, followed by sub-cutaneous (s.c.) injections of 2 dose levels of secukinumab versus placebo in patients with active RA who are intolerant to or have had an inadequate response to anti-TNF-α agents, and to provide efficacy/safety data for filing of secukinumab in RA with health authorities globally. Patients will have to be on background MTX therapy throughout the study. At Week 24, efficacy will be assessed based on signs and symptoms according to the American College of Rheumatology response criteria (ACR20 response). Treatment will continue up to 2 years to assess the long term efficacy (especially on structural damage) and safety of secukinumab treatment with combination with MTX in RA.
1. Presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening
2. patients need to have been intolerant or shown inadequate response to at least 1 DMARD
3. Patients must be taking MTX for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization
18 - 99
Healthy Volunteers Needed
Duration of Participation
Up to 2 years.
The patient will receive $25 per study visit for travel expenses.