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NCT02065700 · ClinicalTrials.gov registry record · Phase 2
Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants
A Phase 2 study of Rheumatoid Arthritis, sponsored by Galapagos.
- Completed
- Registry status
- Phase 2
- Development phase
- 739
- Enrollment target
- 20
- Study locations
NCT02065700: Completed Phase 2 study of Rheumatoid Arthritis, sponsored by Galapagos.
NCT02065700 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by Galapagos. The registered enrollment target is 739 participants, below the 4,687-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02065700, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by Galapagos.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 739 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
An Adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investi
Conditions Studied
Interventions
- DRUG Filgotinib
Study Locations (20)
Other
- Atencion Integral en Reumatologa - Buenos Aires
- CER Intituto Medico - Buenos Aires
- Organizacion Medica de Investigaciones (OMI) - Buenos Aires
- Instituto Reumatologico Strusberg - Córdoba
- CIMeL Centro dee Investigacion Medico Lanus - Lanús
Florida
- RASF Clinical Research Center - Boca Raton
- Millenium Research - Ormond Beach
- Lovelace Scientific Resources - Venice
Arizona
- Arthro, Arthritis Care & Research - Gilbert
- Arizona Arthritis & Rheumatology Research PLLC - Mesa
California
- C.V. Mehta MD Medical Corp. - Hemet
- Desert Medical Advances - Palm Desert
Texas
- Austin Rheumatology Research PA - Austin
- Pioneer Research Solutions Inc - Houston
Illinois
- Springfield Clinic - Springfield
Maryland
- Klein and Associates MD, PA - Hagerstown
North Carolina
- Physicians East - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 739 participants |
| Start Date | 2014-02-25 |
| Est. Completion | 2023-01-19 |
| Phase | Phase 2 |
What the finished NCT02065700 record still lists
NCT02065700 is an interventional study that assigns participants to a tested intervention. The registered 739 participants enrollment target is mid-sized for trials with a published cap, below the 4,687-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Filgotinib is the first listed.
NCT02065700 names 20 study sites across 11 states, led by Other, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02065700 about?
NCT02065700 is a clinical study titled "Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants". 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, GLPG063...
What is the current status of trial NCT02065700?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 739 participants. The study started on 2014-02-25. Estimated completion is 2023-01-19.
What conditions does trial NCT02065700 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT02065700?
The interventions under investigation include: Filgotinib (DRUG).
Who is sponsoring clinical trial NCT02065700?
This trial is sponsored by Galapagos, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02065700 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02065700's enrollment target sits among peer trials
739 31st of 197 higher than 167 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
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