NCT01894516

Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) 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 of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated.

Detailed description

* Treatment duration was 24 weeks in total. * However, at Week 12, all participants on placebo and the participants on the 50 mg dose who had not achieved 20% improvement in swollen joint count (SJC66) and tender joint count (TJC68) were assigned (automatically via interactive web response system (IWRS)) to 100 mg once daily (QD) in a blinded fashion and continued treatment until Week 24. * Participants in the other groups maintained their randomized treatment until Week 24.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	GLPG0634	GLPG0634 capsules.
DRUG	Placebo	Placebo capsules.

Timeline

• Start date: 2013-10-08
• Primary completion: 2015-03-05
• Completion: 2015-05-29
• First posted: 2013-07-10
• Last updated: 2020-12-16
• Results posted: 2020-11-19

Locations

82 sites across 19 countries: United States, Argentina, Australia, Austria, Bulgaria, Chile, Colombia, Germany, Guatemala, Hungary, Latvia, Mexico, Moldova, New Zealand, Poland, Romania, Russia, Spain, Ukraine