NCT01211249

GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	GLPG0259 oral capsule	Two capsules, each containing 25 mg of GLPG0259 (i.e. 50 mg/day), to be given once daily; in case of adverse events the dose may be split over two administrations, or reduced to 25 mg/day (one single capsule)
DRUG	Placebo	Placebo capsules; two capsules to be taken in the morning, in case of adverse events the dose may be split over two administrations, or reduced to one single capsule
DRUG	GLPG0259 (Part B)	Capsule, dosage to be established based on results of Part A
DRUG	Placebo (Part B)	Capsules, dosage to be established after Part A, and matching GLPG0259 (Part B)

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-09-29
• Last updated: 2011-04-26

Locations

32 sites across 5 countries: Belgium, Netherlands, Poland, Russia, Ukraine