5507W-13: Mease Galapagos GLPG0634-CL-203

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

Type of Study
Rheumatology - Rheumatoid Arthritis
Short Description
  • 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 quality of life will be evaluated.

Principal Investigator
Philip J. Mease, MD
Eligibility Notes

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.
Start Date
Contact Name
Reda Tipton
Alternate Phone
Alternate Email