drugset / Trial / NCT01668641

Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients

NCT01668641

Phase 2 Completed 91 enrolled Lakefront Biotherapeutics NV
RandomizedParallel-groupQuadruple-blindTreatment

Summary

* Ninety patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 (4 different doses will be evaluated) or matching placebo for 4 weeks. * During the course of the study, patients will also be examined for any side effects that may occur, and the amount of GLPG0634 present in the blood as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be determined.

Timeline

Start
2012-05
Primary completion
2012-09
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Filgotinib Small molecule 30 mg Oral
Subject Filgotinib Small molecule 75 mg Oral
Subject Filgotinib Small molecule 150 mg Oral
Subject Filgotinib Small molecule 300 mg Oral

Indications