Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)
Public ClinicalTrials.gov record NCT01888874. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram \[mg\], 100 mg and 200 mg daily -, each evaluated as once daily \[QD\] and twice daily \[BID\] regimen) 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 and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.
Study identification
- NCT ID
- NCT01888874
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 599 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 16, 2013
- Primary completion
- Feb 17, 2015
- Completion
- May 13, 2015
- Last update posted
- Nov 16, 2020
2013 – 2015
United States locations
- U.S. sites
- 28
- U.S. states
- 17
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rheumatology Associates of North Alabama, PC | Huntsville | Alabama | — | — |
| Artho Care, Arthritis Care & Research P.C. | Gilbert | Arizona | — | — |
| Arizona Arthritis & Rheumatology Research PLLC | Phoenix | Arizona | — | — |
| C.V. Mehta MD Medical Corporation | Hemet | California | — | — |
| Center for Innovative TherapyDivision of Rheumatology, UCSD | La Jolla | California | — | — |
| Desert Medical Advances | Palm Desert | California | — | — |
| Desert Valley Medical Center | Victorville | California | — | — |
| Infosphere Clinical Research, Inc. | West Hills | California | — | — |
| RASF Clinical Research Center | Boca Raton | Florida | — | — |
| Millennium Research | Ormond Beach | Florida | — | — |
| Lovelace Scientific Resources | Venice | Florida | — | — |
| Arthritis Center of North GA | Gainesville | Georgia | — | — |
| Idaho Arthritis Center | Meridian | Idaho | — | — |
| The Arthritis Center | Springfield | Illinois | — | — |
| Professional Research Network of Kansas | Wichita | Kansas | — | — |
| Arthritis Treatment Center | Frederick | Maryland | — | — |
| Klein and Associates MD | Hagerstown | Maryland | — | — |
| Private practice | Lansing | Michigan | — | — |
| Mayo Clinic | Rochester | Minnesota | — | — |
| Physicians East | Greenville | North Carolina | — | — |
| Health Research of Oklahoma | Oklahoma City | Oklahoma | — | — |
| Altoona Center Clinical Research | Duncansville | Pennsylvania | — | — |
| Austin Rheumatology Research PA | Austin | Texas | — | — |
| Arthritis Centers of Texas | Dallas | Texas | — | — |
| Pioneer Research Solutions Inc | Houston | Texas | — | — |
| Crossroads Clinical Research, LLC | Victoria | Texas | — | — |
| Seattle Rheumatology Associates, PLLC | Seattle | Washington | — | — |
| Mountain State Clinical Research | Clarksburg | West Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 114 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01888874, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 16, 2020 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01888874 live on ClinicalTrials.gov.