At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of RA confirmed by American College of Rheumatology criteria for at least 3 months prior to screening
- ✓Active RA at screening and baseline with ≥6 swollen joints AND ≥6 tender joints plus additional laboratory criteria
- ✕Other inflammatory diseases (ankylosing spondylitis, systemic lupus erythematosus, Lyme disease, etc.)
- ✕Prior non-MTX DMARDs (e.g., D-penicillamine, hydroxychloroquine, chloroquine, oral/parenteral gold, anakinra, azathioprine, sulphasalazine) within 4 weeks of first study dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
In Brief
A Phase 2 clinical trial evaluating Golimumab, MTX, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 172 participants.
Detailed Summary
Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.
Study Details
Timeline
Interventions
Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.
Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous
Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous
Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous