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

NCT02065700 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 739

Last updated 2024-06-04

Study results available
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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

Interventions

DRUG

Filgotinib

Administered as Oral Tablets

Sponsors & Collaborators

Principal Investigators

  • Galapagos Study Director · Galapagos NV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-25
Primary Completion
2023-01-19
Completion
2023-01-19
FDA Drug
Yes

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

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02065700 on ClinicalTrials.gov