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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| capsule, 30mg GLPG0634 once a day | Experimental | 3 capsules of 10 mg once a day |
|
| capsules, 75mg GLPG0634 once a day | Experimental | 3 capsules of 25mg once a day |
|
| capsules, 150mg GLPG0634 once a day | Experimental | 3 capsules of 50mg once a day |
|
| capsules, 300mg GLPG0634 once a day | Experimental | 3 capsules of 100mg once a day |
|
| capsules, placebo once a day | Placebo Comparator | 3 capsules placebo once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG0634 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 4 (end of treatment visit) |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | From Day -1 up to end of treatment visit (week 4) |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Vanhoutte, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Budai Irgalamsrendi Korhaz, II. Reumatologia Osztaly | Budapest | Hungary | ||||
| Orszagos Reumatologiai es Fizioterapias Intezet, I. Reumatologia Osztaly |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28622463 | Derived | Vanhoutte F, Mazur M, Voloshyn O, Stanislavchuk M, Van der Aa A, Namour F, Galien R, Meuleners L, van 't Klooster G. Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Filgotinib, a Selective JAK-1 Inhibitor, After Short-Term Treatment of Rheumatoid Arthritis: Results of Two Randomized Phase IIa Trials. Arthritis Rheumatol. 2017 Oct;69(10):1949-1959. doi: 10.1002/art.40186. Epub 2017 Aug 31. |
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| Placebo | Drug |
|
| 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) | 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 | 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 | 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 | To characterize the pharmacodynamics (PD) of GLPG0634 by measuring the levels of immune- and inflammation-related parameters in plasma | Day -1, Week 1, week 2 and week 4 visits |
| 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 |
| Chernivtsi Regional Clinical Hospital | Chernivtsi | Ukraine |
| State Institution 'Institute of Urgent and Recovery Surgery n.a. V.K. Gusaka' of AMS of Ukraine | Donetsk | Ukraine |
| Communal Institution of Healthcare | Kharkiv | Ukraine |
| Institution of Therapy of AMS of Ukraine | Kharkiv | Ukraine |
| State Institution 'Institute of Microbiology and Immunology of AMS of Ukraine' | Kharkiv | Ukraine |
| State Institution 'Republican Clinical Hospital of MoH of Ukraine' | Kiev | Ukraine |
| Lutsk City Clinical Hospital | Lutsk | Ukraine |
| Vinnytsa Regional Clinical Hospital | Vinnytsa | Ukraine |
| Zaporizhzhia Regional Clinical Hospital | Zaporizhzhia | Ukraine |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
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