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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study of Golimumab (CNTO148) Monotherapy in Patients With Active Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: CNTO 148
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CNTO 148 50 mg<br> | Drug: CNTO 148<br>* 50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.<br>* Other names: Golimumab;|
| Experimental: CNTO 148 100 mg<br> | Drug: CNTO 148<br>* 50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.<br>* Other names: Golimumab;|
| Experimental: Placebo<br> | Drug: Placebo<br>* Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks until week 12 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 116.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR 20% response |  | Weel 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Fully Human anti-TNFa monoclonal antibody, CNTO148, Golimumab