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: 4. Screening serum CRP = 0.7 x upper limit of the normal (reference) laboratory range (ULN). 5. Have shown an inadequate response in terms of either lack of efficacy or toxicity to MTX. 6. Have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period. XML File Identifier: OcyU8OCsxb11xEH51L9Ic43sycA= Page 18/30 7. 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. 8. If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least 2 weeks prior toBaseline. 9. The results of the following laboratory tests performed at the central laboratory at Screening must be within the limits specified below: a) Hemoglobin =10 g/d (International System of Units [SI]: =100 g/L); b) WBCs =3.0 x 103 cells/mm3 (SI: =3.0 x 109 cells/L); c) Neutrophils =2.0 x 103 cells/mm3 (SI: =2.0 x 109 cells/L); d) Lymphocytes =1.0 x 103 cells/mm3 (SI: =1.0 x 109 cells/L); e) Platelets =100 x 103 cells/mm3 (SI: =100 x 109 cells/L); f) Serum ALT and aspartate aminotransferase (AST) =1.5 x ULN; g) Total bilirubin level =1.25 x ULN; h) Alkaline phosphatase =1.5ULN; i) Lipase =1.5 x ULN and amylase =1.5 x ULN; j) Creatinine clearance >60 mL/min. Creatinine clearance will be calculated using the Cockroft-Gault formula. 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 224 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56
Exclusion criteria
Exclusion criteria: applicable: Current therapy with any non-biological DMARD, including oral or injectable gold, sulfasalazine, 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 calendar days of standard cholestyramine therapy, with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to Baseline. 3. 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. 4. Previous treatment at any time with a cytotoxic agent, other than MTX, before Screening. These agents include, but are not limited to chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents. Please see study protocol for full details
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 12;Secondary Objective: The secondary objectives of the study are: • To evaluate the efficacy in terms of the percentage of subjects achieving an ACR20, ACR50, ACR70, ACR N, DAS28(CRP), EULAR response and ACR/EULAR remission, CDAI, and SDAI with different doses of GLPG0634 given once daily compared with placebo at every visit. • To evaluate the safety and tolerability of different doses of GLPG0634 in comparison with placebo. • To characterize the population PK and PD of GLPG0634 and its metabolite (G254445) in subjects with rheumatoid arthritis and investigate the relationship between exposure and efficacy/safety/PD. • To evaluate the effects of different doses of GLPG0634 administration on subjects’ disability, fatigue, and quality of life. ;Main Objective: The primary objective of the study is to evaluate the efficacy in terms of the percentage of subjects achieving an ACR20 response, of different doses of GLPG0634 given once daily compared with placebo at Week 12.;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 | — |
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, 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