CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 739 enrolled
Drug / intervention
Filgotinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02065700
NCT02065700Phase 2Completed

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

Lakefront Biotherapeutics NV·interventional·Posted Feb 19, 2014·Updated Jun 4, 2024

In Brief

A Phase 2 clinical trial evaluating Filgotinib for Rheumatoid Arthritis. Completed, enrolled 739 participants across 111 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Bulgaria, Chile, Colombia, Czechia, France, Germany, Guatemala, Hungary, Israel, Latvia, Mexico, Moldova, New Zealand, Poland, Romania, Russia, Spain, Ukraine, United States
CollaboratorsGilead Sciences

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2014
Enrollment StartFeb 25, 2014
Primary CompletionJan 19, 2023
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 12.4 years ago

Interventions

Filgotinibdrug

Administered as Oral Tablets