None listed
Conditions
Interventions
Twelve weeks of treatment with GLPG0634 50 mg,
100 mg or 200 mg once daily (q.d.)
25 mg, 50 mg or 100 mg twice daily (b.i.d.)
or placebo. At Week 12, subjects on placebo who have not achieved 20%
improvement in swollen joint count (SJC66) and tender joint count (TJC68) will be re-randomized (automatically via IXRS) to tre
Sponsors
Galapagos N.V,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
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
Exclusion criteria: • Current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX, including oral or injectable gold, sulfasalazine, antimalarials, azathioprine, or D-penicillamine within 4 weeks prior to Baseline, cyclosporine within 8 weeks prior to Baseline, and leflunomide within 3 months prior to Baseline or a minimum 4 weeks prior to Baseline if after 11 days of standard cholestyramine therapy, • 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.
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Chile, Colombia, Czech Republic, France, Germany, Guatemala, Hungary, Israel, Lithuania, Mexico, New Zealand, Peru, Poland, Russian Federation, Spain, Ukraine, United States
Contacts
Public ContactMarcela Toledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed