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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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (116% higher). 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.
Primary Outcome
The American College of Rheumatology (ACR) response is a measurement of improvement in multiple disease assessment criteria. The ACR20 response is defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in tender TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), 2. Patient's Global Assessment of Disease Activ
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 |
What the finished NCT01894516 record still lists
NCT01894516 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (116% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01894516 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01894516's enrollment target sits among peer trials
287 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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