Status:
COMPLETED
Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow...
Eligibility Criteria
Inclusion
- Presence of RA classified by ACR 1987 revised criteria. Patients with active RA should have been on MTX for at least 3 months and must currently be treated with a stable dose of MTX (\> or =7.5 mg/week - \< or = 25 mg/week) for at least 4 weeks
- At Baseline: Disease activity criteria defined by \> or = 6 out of 28 tender joints and \> or = 6 out of 28 swollen joints WITH either Screening value of hsCRP \> or = 10 mg/L OR ESR \> or = 28 mm/1st hr
Exclusion
- RA patients functional status class IV classified according to the ACR 1991 revised criteria
- Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
- Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare within 4 weeks before randomization
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00928512
Start Date
July 1 2009
End Date
March 1 2011
Last Update
October 30 2015
Active Locations (58)
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1
Novartis Investigative Site
Mesa, Arizona, United States, 85202
2
Novartis Investigative Site
Peoria, Arizona, United States, 85381
3
Novartis Investigative Site
Little Rock, Arkansas, United States, 72205
4
Novartis Investigative Site
Santa Monica, California, United States, 90404