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NCT01894516 · ClinicalTrials.gov registry record · Phase 2
Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)
A Phase 2 study, sponsored by Lakefront Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 287
- Enrollment target
NCT01894516: Completed Phase 2 study, sponsored by Lakefront Biotherapeutics.
NCT01894516 is a Phase 2 study that has completed, run by Lakefront Biotherapeutics. The registered enrollment target is 287 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01894516, a Phase 2 study, has completed, sponsored by Lakefront Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 287 participants
- Enrollment target
Study Summary
* Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) or matching placebo for 24 weeks. * During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated.
Interventions
- DRUG Placebo
- DRUG GLPG0634
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2013-10-08 |
| Est. Completion | 2015-05-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01894516
The ClinicalTrials.gov registry entry for NCT01894516 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 287 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lakefront Biotherapeutics, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01894516 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01894516 about?
NCT01894516 is a clinical study titled "Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)". * Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) or matching placebo for 24 ...
What is the current status of trial NCT01894516?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 287 participants. The study started on 2013-10-08. Estimated completion is 2015-05-29.
What interventions are being tested in trial NCT01894516?
The interventions under investigation include: Placebo (DRUG), GLPG0634 (DRUG).
Who is sponsoring clinical trial NCT01894516?
This trial is sponsored by Lakefront Biotherapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
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