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: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-003635-31-CZ
• Lead Sponsor: Galapagos NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-31
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 595

Inclusion Criteria

To be eligible for study entry subjects must fulfil all of the following criteria:
1. Male or female subjects who are =18 years of age, on the day of signing informed consent.
2. Diagnosis of RA since at least 6 months prior to Screening and
meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III.
3. Have =6 swollen joints (from a 66 joint count) and =8 tender joints (from a 68 joint count) at Screening and Baseline, and a Screening serum CRP =0.70 x upper limit of the normal (reference) laboratory range (ULN).
4. Have received MTX (oral or parenteral) for =6 months and have been on a stable dose (15 mg/week to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on this regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed, when there is documented evidence of intolerance or safety issues at higher doses.
5. 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.
6. If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least 2 weeks prior to Baseline.

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 475
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

Subjects will be excluded from the study if one or more of the following statements are applicable:
1. Current therapy with any DMARD other than MTX, including oral or injectable
gold, sulfasalazine, antimalarials, 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 days of standard cholestyramine therapy.
2. 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.

Please see study protocol for full details.

Study & Design

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