A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
Phase 2
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: P38 Inhibitor (4) 50mgDrug: P38 Inhibitor (4) 25mgDrug: P38 Inhibitor (4) 300mgDrug: P38 Inhibitor (4) 75mgDrug: P38 Inhibitor (4) 150mgDrug: Placebo
- Registration Number
- NCT00316771
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 374
Inclusion Criteria
- adult patients >=18 years of age;
- active rheumatoid arthritis;
- current inadequate clinical response to methotrexate.
Exclusion Criteria
- receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P38 Inhibitor (4) 50mg P38 Inhibitor (4) 50mg - P38 Inhibitor (4) 25mg P38 Inhibitor (4) 25mg - P38 Inhibitor (4) 300mg P38 Inhibitor (4) 300mg - P38 Inhibitor (4) 75mg P38 Inhibitor (4) 75mg - P38 Inhibitor (4) 150mg P38 Inhibitor (4) 150mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percentage of patients with ACR 20 response Week 12
- Secondary Outcome Measures
Name Time Method Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters. Throughout study Percentage of patients with ACR 50/70 response Week 12