Phase 2 Completed N=172 Randomized Double-blind Treatment

An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Source: ClinicalTrials.gov NCT00207714 ↗

Enrolled (actual)

172

Serious AEs

14.0%

Results posted

Aug 2012

Primary outcomePrimary: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 — 13; 21; 17; 19 Participants — p=0.010

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16	13; 21; 17; 19; 27; 84	0.010 sig
SECONDARY Summary of ACR-N, Index of Improvement at Week 16	0.0; 37.4; 19.4; 22.3; 35.6; 33.3	0.001 sig

Eligibility Criteria

Inclusion Criteria

Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria

Exclusion Criteria

Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
Received disease-modifying antirheumatic drugs ([DMARDs] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin [IL]-1 receptor antagonist [anakinra], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose

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Data sourced from ClinicalTrials.gov (NCT00207714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.