* Ninety patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 (4 different doses will be evaluated) or matching placebo for 4 weeks. * During the course of the study, patients will also be examined for any side effects that may occur, and the amount of GLPG0634 present in the blood as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be determined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
Budai Irgalamsrendi Korhaz, II. Reumatologia Osztaly
Budapest, Hungary
The number of patients with an ACR20 score at Week 4 as a measure of efficacy
To preliminary evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4
Time frame: Week 4 (end of treatment visit)
The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy
To evaluate the efficacy of GLPG0634 compared to placebo in terms of ACR response criteria at every visit (ACR20, ACR50, ACR70), time to response, and disease status (DAS28\[C-reactive protein, CRP\]
Time frame: From Day -1 up to end of treatment visit (week 4)
The number of patients with adverse events, abnormal lab tests, vital signs and ECG as a measure of safety and tolerability
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs), laboratory test abnormalities, vital signs and electrocardiogram (ECG)
Time frame: From screening up to 10 days after last dose
The plasma levels of GLPG0634 as a measure of PK
To characterize the pharmacokinetics (PK) of GLPG0634 by measuring the amount of GLPG0634 in the plasma
Time frame: Week 1, week 2 and week 4 visits
The plasma levels of GLPG0634 and MTX as a measure of PK
To explore the potential interaction of GLPG0634 on MTX by assessing steady state PK in an 8-hour sampling at Day -1 and at Week 2 or Week 4 visit in a subset of patients
Time frame: Day -1 and Week 2 or 4 visit (8 hour-sampling)
The levels of immune- and inflammation-related parameters in plasma as a measure of PD
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Orszagos Reumatologiai es Fizioterapias Intezet, I. Reumatologia Osztaly
Budapest, Hungary
Markhot Ferenc Korhaz, Reumatologiai Osztaly
Eger, Hungary
Pest Megyei Flor Ferenc Korhaz, Reumatologiai es Fizioterapias Osztaly
Kistarcsa, Hungary
IMSP Institutel de Cardiologie
Chisinau, Moldova
State Healthcare Institution of city Moscow 'City Clinical Hospital #7'
Moscow, Russia
State Healthcare Institution 'Ryazan Regional Cardiology Dispensary'
Ryazan, Russia
Saint-Petersburg State Healthcare Institution 'City Hospital #26'
Saint Petersburg, Russia
Saint-Petersburg State Healthcare Institution 'City Mariinskiy Hospital'
Saint Petersburg, Russia
Municipal Clinical Healthcare Institution 'Medical-Sanitary Unit of Novoyaroslavskiy Oil Refinery'
Yaroslavl, Russia
...and 9 more locations
To characterize the pharmacodynamics (PD) of GLPG0634 by measuring the levels of immune- and inflammation-related parameters in plasma
Time frame: Day -1, Week 1, week 2 and week 4 visits