Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)
Status:
Completed
Trial end date:
2015-05-14
Target enrollment:
Participant gender:
Summary
Participants suffering from active rheumatoid arthritis despite continued treatment with
methotrexate were evaluated for improvement of disease activity (efficacy) when taking
GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as
once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks.
•During the course of the study, patients were also examined for any side effects that could
occur (safety and tolerability), and the amount of GLPG0634 present in the blood
(Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of
action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects
of different doses and dose regiments of GLPG0634 administration on participants' disability,
fatigue, and quality of life were evaluated.