Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01888874

Run by

Lakefront Biotherapeutics NV

People needed

599

Starts

2013-07-17

Expected to finish

2015-05-14

Last updated by the study team

2020-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,
• have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint count) at Screening and at Baseline,
• Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range (ULN),
• have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.

You may not qualify if…

• current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX,
• current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
• previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.

Where it is running

• Artho Care, Arthritis Care & Research P.C. — Gilbert, Arizona, United States
• Arizona Arthritis & Rheumatology Research PLLC — Phoenix, Arizona, United States
• C.V. Mehta MD Medical Corporation — Hemet, California, United States
• Center for Innovative TherapyDivision of Rheumatology, UCSD — La Jolla, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Desert Valley Medical Center — Victorville, California, United States
• Infosphere Clinical Research, Inc. — West Hills, California, United States
• RASF Clinical Research Center — Boca Raton, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• Lovelace Scientific Resources — Venice, Florida, United States
• Arthritis Center of North GA — Gainesville, Georgia, United States
• Idaho Arthritis Center — Meridian, Idaho, United States
• The Arthritis Center — Springfield, Illinois, United States
• Professional Research Network of Kansas — Wichita, Kansas, United States
• Arthritis Treatment Center — Frederick, Maryland, United States
• Klein and Associates MD — Hagerstown, Maryland, United States
• Private practice — Lansing, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Physicians East — Greenville, North Carolina, United States
• Health Research of Oklahoma — Oklahoma City, Oklahoma, United States
• Altoona Center Clinical Research — Duncansville, Pennsylvania, United States
• Austin Rheumatology Research PA — Austin, Texas, United States
• Arthritis Centers of Texas — Dallas, Texas, United States
• Pioneer Research Solutions Inc — Houston, Texas, United States
• Rheumatology Associates of North Alabama, PC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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