moderately to severely active rheumatoid arthritis MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Galapagos NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for study entry subjects must fulfil all of the following criteria: 1. Male or female subjects who are =18 years of age, on the day of signing informed consent. 2. Diagnosis of RA since at least 6 months prior to Screening and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III. 3. Have =6 swollen joints (from a 66 joint count) and =8 tender joints (from a 68 joint count) at Screening and Baseline, and a Screening serum CRP =0.70 x upper limit of the normal (reference) laboratory range (ULN). 4. Have received MTX (oral or parenteral) for =6 months and have been on a stable dose (15 mg/week to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on this 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. 5. If taking oral steroids, these should be at a dose =10 mg/day of prednisone or prednisone equivalent and stable for at least 4 weeks prior to Baseline. 6. If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least 2 weeks prior to Baseline. Please see study protocol for full details Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 475 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if one or more of the following statements are applicable: 1.Current therapy with any DMARD other than MTX, including oral or injectable gold, sulfasalazine, antimalarials, azathioprine, or D penicillamine within 4 weeks prior to Baseline, cyclosporine within 8 weeks prior to Baseline, and leflunomide within 3 months prior to Baseline or a minimum 4 weeks prior to Baseline if after 11 days of standard cholestyramine therapy. 2. Current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs •administered in a single clinical study setting, and; •more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; •where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy. Please see study protcol for full details
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy in terms of the percentage of subjects achieving an American College of Rheumatology (ACR)20 response, of different doses and dose regimens of GLPG0634 compared to placebo at Week 12.;Secondary Objective: The secondary objectives are to evaluate the efficacy in terms of the percentage of subjects achieving an ACR20, ACR50, ACR70, ACR N, the disease activity score based on 28 joints (DAS28 [c-reactive protein {CRP}]), European League Against Rheumatism (EULAR) response and ACR/EULAR remission, clinical disease activity index (CDAI), and simplified disease activity index (SDAI) with different doses and dose regimens of GLPG0634 compared to placebo at every visit; to evaluate the safety and tolerability of different doses and dose regimens of GLPG0634 in comparison with placebo; to characterize the population pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 and its metabolite (G254445) in subjects with rheumatoid arthritis (RA) and investigate the relationship between exposure and efficacy/safety/PD; and to evaluate the effects of different doses and dose regimens of GLPG0634 administration on subjects’ disability, fatigue, and quality of life. ;Primary end point(s): The primary endpoint is the percentage of subjects achieving an ACR20 response at Week 12. Other time points will be regarded as secondary endpoints;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of subjects achieving ACR20 response at Week 24, percentage of subjects achieving ACR50, ACR70, ACR N, DAS28(CRP), EULAR response and ACR/EULAR remission, CDAI, SDAI response, the change in Baseline in Quality of Life (functional assessment of chronic illness therapy [FACIT] and short form 36 [SF-36]) scores at Weeks 1, 2, 4, 8, 12, and 24, as appropriate.;Timepoint(s) of evaluation of this end point: weeks 1, 2, 4, 8, 12 and week 24. | — |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Chile, Colombia, Czech Republic, France, Germany, Guatemala, Hungary, Israel, Latvia, Lithuania, Mexico, Moldova, Republic of, New Zealand, Peru, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United States
Contacts
Public ContactClinical Trial Information Desk
Galapagos NV
Outcome results
None listed