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

November 2, 2015 updated by: Janssen Pharmaceutical K.K.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

311

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Asahikawa, Japan
      • Ayauta, Japan
      • Azumino, Japan
      • Chiba, Japan
      • Fuchu, Japan
      • Fukui, Japan
      • Fukuoka, Japan
      • Fukushima, Japan
      • Gifu, Japan
      • Goshogawara, Japan
      • Hachioji, Japan
      • Hamamatsu, Japan
      • Higashi-Hiroshima, Japan
      • Hiki, Japan
      • Hiroshima, Japan
      • Hitachi, Japan
      • Hitachinaka, Japan
      • Iruma, Japan
      • Izumisano, Japan
      • Izumo, Japan
      • Kamakura, Japan
      • Kato, Japan
      • Kawachi-Nagano, Japan
      • Kawagoe, Japan
      • Kawasaki, Japan
      • Kita-Gun, Japan
      • Kitakyushu, Japan
      • Kitamoto, Japan
      • Kobe, Japan
      • Kumamoto, Japan
      • Kyoto, Japan
      • Matsue, Japan
      • Matsumoto, Japan
      • Matsuyama, Japan
      • Nagano, Japan
      • Nagoya, Japan
      • Narashino, Japan
      • Niigata, Japan
      • Nishinomiya, Japan
      • Ohta-Ku, Japan
      • Oita, Japan
      • Osaka, Japan
      • Osaka-Sayama, Japan
      • Osaki, Japan
      • Sagamihara, Japan
      • Saitama, Japan
      • Sapporo, Japan
      • Sasebo, Japan
      • Sendai, Japan
      • Sendai N/A, Japan
      • Shimotsuga, Japan
      • Shimotsuke, Japan
      • Shinjuku-Ku, Japan
      • Shizuoka, Japan
      • Suita, Japan
      • Tokushima, Japan
      • Tokyo, Japan
      • Tokyo N/A, Japan
      • Tomigusuku, Japan
      • Toshima-Ku, Japan
      • Toyama, Japan
      • Toyoake, Japan
      • Toyohashi, Japan
      • Tsu, Japan
      • Tsukuba, Japan
      • Tsukubo, Japan
      • Ube, Japan
      • Yokohama, Japan
      • Yokohama N/A, Japan
      • Yufu, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Drug: Placebo
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.
Experimental: CNTO 148 50 mg
Drug: CNTO 148
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.
Other Names:
  • Golimumab
Experimental: CNTO 148 100 mg
Drug: CNTO 148
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.
Other Names:
  • Golimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ACR 20% response
Time Frame: Weel 14
Weel 14

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: Week 14
Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutical K.K.

Collaborators

Mitsubishi Tanabe Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 10, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (Estimate)

October 13, 2008

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR015343
  • JNS012-JPN-04 (Other Identifier: Janssen Pharmaceutical K.K., Japan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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