RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE IIB DOSE FINDING STUDY OF GLPG0634 ADMINISTERED FOR 24 WEEKS IN COMBINATION WITH METHOTREXATE TO SUBJECTS WITHMODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO METHOTREXATE ALONE

Not Applicable

• Conditions: -M06; M06

• Registration Number: PER-057-13
• Lead Sponsor: Galapagos N.V,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 0

Inclusion Criteria

• Male or female subjects who are ≥18 years of age,
on the day of signing informed consent,
• Have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and
ACR functional class I-III,
• Have ≥6 swollen joints (from a 66 joint count) and
≥8 tender joints (from a 68 joint count) at Screening
and at Baseline,
• Screening serum c-reactive protein ≥1.5 x upper
limit of laboratory normal range (ULN),
• Have received MTX for ≥6 months and have been
on a stable dose (15 to 25 mg/week) of MTX for at
least 4 weeks prior to Screening and willing to
continue on their current 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.

Exclusion Criteria

• Current therapy with any disease-modifying
anti-rheumatic drugs (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,
• Current or previous RA treatment with a biologic
DMARD, with the exception of biologic DMARDs
administered in a single clinical study setting more
than 6 months prior to Screening (12 months for
rituximab or other B cell depleting agents), where
the biologic DMARD was effective, and if
discontinued, this should not be due to lack of
efficacy,
• Previous treatment at any time with a cytotoxic
agent, other than MTX, before Screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified