Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

Launched by GALAPAGOS NV · Jul 9, 2013

Keywords

ClinConnect Summary

* Treatment duration was 24 weeks in total.
* However, at Week 12, all participants on placebo and the participants on the 50 mg dose who had not achieved 20% improvement in swollen joint count (SJC66) and tender joint count (TJC68) were assigned (automatically via interactive web response system (IWRS)) to 100 mg once daily (QD) in a blinded fashion and continued treatment until Week 24.
* Participants in the other groups maintained their randomized treatment until Week 24.

Gender

ALL

Eligibility 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 ≥ 0.7 x upper limit of laboratory normal range (ULN),
• • have shown an inadequate response in terms of either lack of efficacy or toxicity to MTX,
• • have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period.
• Exclusion Criteria:
• • current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD), with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to Screening,
• • current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs: administered in a single clinical study setting, and; more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; 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.