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

Centocor Ortho Biotech

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Golimumab; Drug: Infliximab; Drug: Placebo; Drug: MTX

Study type: Interventional

Funder types: Industry

Identifiers

NCT00207714

C0524T02 (Other Identifier)

CR005263

Details and patient eligibility

About

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.

Full description

This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.

Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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172 participants in 3 patient groups, including a placebo group

Golimumab (CNTO 148) with Methotrexate (MTX)

Experimental group

Treatment:

Drug: Golimumab

Drug: MTX

Infliximab with MTX

Experimental group

Treatment:

Drug: MTX

Drug: Infliximab

Placebo with MTX

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: MTX