Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants
Completed · Phase 2
Conditions studied: Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT02065700
- Run by
- Lakefront Biotherapeutics NV
- People needed
- 739
- Starts
- 2014-02-25
- Expected to finish
- 2023-01-19
- Last updated by the study team
- 2024-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Arthritis & Rheumatology Research PLLC — Mesa, Arizona, United States
- C.V. Mehta MD Medical Corp. — Hemet, California, United States
- Desert Medical Advances — Palm Desert, California, United States
- RASF Clinical Research Center — Boca Raton, Florida, United States
- Millenium Research — Ormond Beach, Florida, United States
- Lovelace Scientific Resources — Venice, Florida, United States
- Springfield Clinic — Springfield, Illinois, United States
- Klein and Associates MD, PA — Hagerstown, Maryland, United States
- Physicians East — Greenville, North Carolina, United States
- Health Research of Oklahoma — Oklahoma City, Oklahoma, United States
- Low County Rheumatology PA — Charleston, South Carolina, United States
- West Tennessee Research Institute — Jackson, Tennessee, United States
- Austin Rheumatology Research PA — Austin, Texas, United States
- Pioneer Research Solutions Inc — Houston, Texas, United States
- Atencion Integral en Reumatologa — Buenos Aires, Argentina
- CER Intituto Medico — Buenos Aires, Argentina
- Organizacion Medica de Investigaciones (OMI) — Buenos Aires, Argentina
- Instituto Reumatologico Strusberg — Córdoba, Argentina
- CIMeL Centro dee Investigacion Medico Lanus — Lanus, Argentina
- Instituto CAICI — Rosario, Argentina
- Instituto de Asistencia Reumatologia Integral - IARI — San Fernando, Argentina
- Centro Médico Privado de Reumatologia — San Miguel de Tucumán, Argentina
- Flinders Medical Centre — Bedford Park, Flinders Drive, South Australia, Australia
- Monash Medical Centre — Clayton, Victoria, Australia
- Arthro, Arthritis Care & Research — Gilbert, Arizona, United States
Full record on ClinicalTrials.gov
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