A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | November 2005 |
| End Date: | March 2008 |
A Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy.
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.
(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.
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.
We found this trial at
46
sites
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