Rheumatoid Arthritis Clinical Trial
Official title:
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.
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 374 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Australia, Brazil, Canada, Estonia, Germany, Greece, Ireland, Mexico, New Zealand, Poland, South Africa, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients with ACR 20 response | Week 12 | No | |
Secondary | Percentage of patients with ACR 50/70 response | Week 12 | No | |
Secondary | Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters. | Throughout study | No |
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