Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

• Conditions: moderately to severely active rheumatoid arthritis; MedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-003654-86-DE
• Lead Sponsor: Galapagos NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-03
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

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.
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 to Baseline.
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

applicable:
1. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified