A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: CNTO 148; Drug: Placebo; Drug: Methotrexate (MTX)

• Registration Number: NCT00727987
• Lead Sponsor: Janssen Pharmaceutical K.K.

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.

Detailed Description

This clinical study is scheduled to be performed for the purpose of evaluating the safety and effectiveness of golimumab (CNTO148) administered in combination with stable dose (6-8mg/week) of methotrexate (MTX) to patients with rheumatoid arthritis (RA). CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 152. If early escape, 100 mg SC injections every 4 weeks from week 16 until week 152. CNTO148 100 mg group: CNTO148 100 mg SC injections every 4 weeks from the first administration until week 152 whether early escape or not Placebo group: Placebo SC injections every 4 weeks from the first administration until week 20 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 152

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-08-04
• Study First Posted: 2008-08-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

• Patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the American College of Rheumatology (1987)
• Patients in whom MTX therapy (>= 6 mg/week) was started more than 3 months before the first administration and who have been treated with MTX at a stable dose (6-8 mg/week) for at least 4 weeks before the first administration
• Patients having at least 4 swollen joints and at least 4 tender joints at the time of registration and immediately before the first administration.

Exclusion Criteria

• Patients with a history of hypersensitivity to human immunoglobulin proteins or other ingredients of golimumab
• Patients who have previously experienced or are suffering from any of the following diseases: (i) Collagen diseases other than rheumatoid arthritis, (ii) Latent or active granulomatous infections such as histoplasmosis and coccidioidomycosis, (iii) Felty syndrome, etc
• Patients with a severe, advanced, or poorly controlled disease in any of the kidney, liver, blood, gastrointestinal system, endocrine system, lung, heart, nervous system, psychiatric system, and brain.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CNTO 148 50 mg + methotrexate	CNTO 148	-
CNTO 148 50 mg + methotrexate	Methotrexate (MTX)	-
CNTO 148 100 mg + methotrexate	Methotrexate (MTX)	-
Placebo + methotrexate	Placebo	-
Placebo + methotrexate	Methotrexate (MTX)	-

Primary Outcome Measures

Name	Time	Method
ACR 20% response	Week 14

Secondary Outcome Measures

Name	Time	Method
ACR 50% response, ACR 70% response, ACR 90% response, Changes from the pretreatment values in the DAS (Disease Activity Score) 28, and the HAQ (Health assessment questionnaire)	Week 14