Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)
Public ClinicalTrials.gov record NCT01894516. 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 as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
* 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.
Study identification
- NCT ID
- NCT01894516
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 287 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
- Oct 8, 2013 (Actual)
- Primary completion
- Mar 5, 2015 (Actual)
- Completion
- May 29, 2015 (Actual)
- Last update posted
- Dec 16, 2020
2013 – 2015
United States locations
- U.S. sites
- 21
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Artho Care, Arthritis Care & Research P.C. | Gilbert | Arizona | — | — |
| Arizona Arthritis & Rheumatology Research PLLC | Mesa | Arizona | — | — |
| Arizona Arthritis Rheum Res | Phoenix | Arizona | — | — |
| Little Rock Diagnostic Clinic | Little Rock | Arkansas | — | — |
| C.V. Mehta MD Medical Corp. | Hemet | California | — | — |
| Center for Innovative Therapy Division of Rheumatology, UCSD | La Jolla | California | — | — |
| Desert Medical Advances | Palm Desert | California | — | — |
| Infosphere Clinical Research, Inc. | West Hills | California | — | — |
| Lovelace Scientific Resources | Venice | Florida | — | — |
| Arthritis Center of North GA | Gainesville | Georgia | — | — |
| The Arthritis Center | Springfield | Illinois | — | — |
| Klein and Associates MD | Hagerstown | Maryland | — | — |
| Private practice | Lansing | Michigan | — | — |
| Arthritis Center of Reno | Reno | Nevada | — | — |
| New Jersey Physicians, LLC | Clifton | New Jersey | — | — |
| Health research of Oklahoma | Oklahoma City | Oklahoma | — | — |
| Altoona Center Clin Research | Duncansville | Pennsylvania | — | — |
| Low Country Rheumatology, PA | Charleston | South Carolina | — | — |
| Arthritis Clinic | Jackson | Tennessee | — | — |
| Austin Rheumatology Research PA | Austin | Texas | — | — |
| Pioneer Research Solutions Inc | Houston | Texas | — | — |
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 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01894516, 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 Dec 16, 2020 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01894516 live on ClinicalTrials.gov.