Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Patients (DARWIN1)

  • 595 patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50mg, 100mg and 200mg daily -, each evaluated as QD and BID regimen) or matching placebo for 24 weeks.
  • During the course of the study, patients will also be examined for any side effects that may 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) will be determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on subjects' disability, fatigue, and q...
January 31, 2014
Rheumatology - Rheumatoid Arthritis
Philip J. Mease, MD

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,

  • Sc...
Reda Tipton