GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT01211249|
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : April 26, 2011
Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will receive once daily two capsules containing either GLPG0259 (25 mg/capsule) or matching placebo, for 12 weeks. In the course of the study the patients will be examined for severity of disease, as well as for any adverse effects that may occur. If needed, dosing may be split to one capsule twice daily, or reduced to one capsule of 25 mg.
Part B: If results of Part A suggest test medication to have a therapeutic advantage over placebo and to be well-tolerated, more patients will be recruited for Part B, where various dosages will be assessed. These dosages will be established based on results from Part A.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: GLPG0259 oral capsule Drug: Placebo Drug: GLPG0259 (Part B) Drug: Placebo (Part B)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination With Methotrexate, Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
|Experimental: GLPG0259 (Part A)||
Drug: GLPG0259 oral capsule
Two capsules, each containing 25 mg of GLPG0259 (i.e. 50 mg/day), to be given once daily; in case of adverse events the dose may be split over two administrations, or reduced to 25 mg/day (one single capsule)
|Placebo Comparator: Placebo (Part A)||
Placebo capsules; two capsules to be taken in the morning, in case of adverse events the dose may be split over two administrations, or reduced to one single capsule
|Experimental: GLPG0259 (Part B)||
Drug: GLPG0259 (Part B)
Capsule, dosage to be established based on results of Part A
|Placebo Comparator: Placebo (Part B)||
Drug: Placebo (Part B)
Capsules, dosage to be established after Part A, and matching GLPG0259 (Part B)
- Efficacy [ Time Frame: 12 weeks ]The primary efficacy endpoint will be the number and percentage of subjects in each GLPG0259 dose group and placebo group achieving an American College of Rheumatology (ACR)20 (ACR20 response rate) at Week 12.
- Efficacy [ Time Frame: intermediate timepoints for 12 weeks ]ACR20, ACR50, ACR75 and DAS28 (and components) at weeks 1, 2, 4, 8 and 12;
- Safety [ Time Frame: 12 weeks ]At each return visit, patients will be asked about adverse events, and undergo examination of heart (ECG) and bloodpressure; blood- and urine-samples will be collected to monitor organ functions.
- Pharmacokinetics [ Time Frame: 12 weeks ]On several timepoints throughout the study bloodsamples will be taken from the patient to establish the amount of the study medication in the blood, and to determine how long it stays in the blood.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211249
|Study Director:||Johan Beetens, PhD||Galapagos NV|