Rheumatoid Arthritis Clinical Trial
Official title:
Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination With Methotrexate, Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment
with methotrexate will receive once daily two capsules containing either GLPG0259 (25
mg/capsule) or matching placebo, for 12 weeks. In the course of the study the patients will
be examined for severity of disease, as well as for any adverse effects that may occur. If
needed, dosing may be split to one capsule twice daily, or reduced to one capsule of 25 mg.
Part B: If results of Part A suggest test medication to have a therapeutic advantage over
placebo and to be well-tolerated, more patients will be recruited for Part B, where various
dosages will be assessed. These dosages will be established based on results from Part A.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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