A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: CNTO 148; Drug: Placebo

• Registration Number: NCT00771251
• 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 DMARD (Disease-modifying antirheumatic drugs) therapy. Another objective is to evaluate the pharmacokinetics of golimumab.

Detailed Description

This study is designed as a placebo-controlled study of golimumab monotherapy for the purpose of demonstrating the safety and effectiveness of golimumab, a new, fully human anti-TNF (Tumor necrosis factor) a monoclonal antibody produced by mean of HuMab mouse technology. Other reasons for using the study design are as follows: the effects of golimumab given alone must be confirmed as in the case of other drugs; and golimumab may be used even in patients not on the treatment with methotrexate (MTX). There will be 3 treatment groups in the study as follows: CNTO148 50 mg group, CNTO 148 100 mg group, and Placebo group.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

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 who have previously not responded to at least one DMARD (before informed consent is obtained)
• Patients who, if they are on the treatment with a DMARD, the DMARD can be washed out for at least 4 weeks before the first administration
• Patients having at least 6 swollen joints and 6 tender joints at the time of registration and immediately before the first injection

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	CNTO 148	-
CNTO 148 100 mg	CNTO 148	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
ACR 20% response	Weel 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