NCT00207714

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Golimumab	Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.
DRUG	MTX	Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous
DRUG	Placebo	Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous
DRUG	Infliximab	Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous

Timeline

• Start date: 2003-11-01
• Primary completion: 2005-02-01
• Completion: 2006-02-01
• First posted: 2005-09-21
• Last updated: 2012-10-18
• Results posted: 2012-08-07