NCT02065700

Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants

A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 739 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis. Participants were enrolled in this open-label long-term follow-up study after they had completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) (NCT01888874) or GLPG0634-CL-204 (DARWIN2) (NCT01894516), and were evaluated for any side effects that might have occured (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants were also examined for long-term effects of filgotinib administration on disease activity (efficacy), participant's disability, fatigue, and quality of life.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Filgotinib	Administered as Oral Tablets

Timeline

• Start date: 2014-02-25
• Primary completion: 2023-01-19
• Completion: 2023-01-19
• First posted: 2014-02-19
• Last updated: 2024-06-04
• Results posted: 2024-06-04

Locations

111 sites across 22 countries: United States, Argentina, Australia, Belgium, Bulgaria, Chile, Colombia, Czechia, France, Germany, Guatemala, Hungary, Israel, Latvia, Mexico, Moldova, New Zealand, Poland, Romania, Russia, Spain, Ukraine

Regulatory

• FDA-regulated drug study