ot applicable

• Conditions: Rheumatoid arthritis; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-005008-14-HU
• Lead Sponsor: Galapagos SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-28
• Last Update Posted: 12 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Male or female subjects who are 18 to 70 years of age, on the day of signing informed consent.
2. Fulfill the revised 1987 American Rheumatism Association (ARA) criteria (Appendix 1) for the classification of RA.
3. Have = 5 swollen joints (from a 66 joint count) and = 5 tender joints (from a 68 joint count), and a serum CRP =1.0 mg/dL.
4. Have received MTX for > 12 weeks and be on a stable dose (7.5 mg/week to 25 mg/week [extremes included]) of MTX for at least 4 weeks prior to screening and willing to continue on this regimen for the duration of the study.
5. If taking oral steroids, these should be at a dose =10 mg/day of prednisone or prednisone equivalent and stable for at least four weeks prior to screening.
6. If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least two weeks prior to screening.
7. The results of the following laboratory tests performed at the central laboratory at screening must be within the limits specified below:
a. Hemoglobin =8.5 g/dL (International System of Units [SI]: =85 g/L);
b. White blood cells =3.0 x 103 cells/mm3 (SI: =3.0 x 109 cells/L);
c. Neutrophils =1.5 x 103 cells/mm3 (SI: =1.5 x 109 cells/L);
d. Platelets =100 x 103 cells/mm3 (SI: =100 x 109 cells/L);
e. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =1.5 x upper limit of laboratory normal range (ULN); and
f. Total bilirubin level =1.25 x ULN;
g. Lipase and amylase within normal range.

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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Current therapy with any disease modifying anti-rheumatic drug (DMARD) other than MTX, including oral or injectable gold, sulfasalazine, hydroxychloroquine, azathioprine, or D penicillamine within four weeks prior to screening, cyclosporine within eight weeks prior to screening, and leflunomide within three months prior to screening.
2. Current or previous RA treatment with a biological agent, with the exception of biologics administered in a single clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents).
3. 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.
4. Previous use of the study drug, GLPG0634.
5. Receipt of an intra-articular or parenteral corticosteroid injection within four weeks prior to screening.

Study & Design

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