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

Location:

Rochester, MN.

Trial status:

Open for Enrollment

Why is this study being done?

- Treatment duration will be 24 weeks in total. - However, at Week 12, subjects on placebo who have not achieved a 20% improvement in swollen joint count(SJC66) and tender joint count (TJC68) will be re-randomized (automatically via interactive voice/web response [IXRS]) to treatment to receive GLPG0634 100 mg q.d. or 50 mg b.i.d. doses in a blinded fashion, subjects on 50 mg q.d. who have not achieved a 20% improvement in SJC66 and TJC68 will be assigned to 100 mg q.d. and subjects on 25 mg b.i.d. who have not achieved a 20% improvement in SJC66 and TJC68 will be assigned to 50 mg b.i.d. All will continue the study until Week 24. - Subjects in the other groups will maintain their randomized treatment until Week 24.

Who is eligible to participate?

Inclusion Criteria: - male or female subjects who are ≥18 years of age, on the day of signing informed consent, - have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III, - have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint count) at Screening and at Baseline, - Screening serum c-reactive protein ≥1.5 x upper limit of laboratory normal range (ULN), - have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses. Exclusion Criteria: - current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX, - current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy, - previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.

Last updated:

7/22/2013

NCT ID:

NCT01888874

IRB Number:

886-03