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

May 22, 2013 updated by: Janssen Pharmaceutical K.K.

A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) 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 Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

269

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
      • Asahi, Japan
      • Asahikawa, Japan
      • Azumino, Japan
      • Chiba, Japan
      • Fukui, Japan
      • Fukuoka, Japan
      • Fukushima, Japan
      • Gifu, Japan
      • Goshogawara, Japan
      • Hachioji, Japan
      • Hamamatsu, Japan
      • Higashi-Hiroshima, Japan
      • Hiki, Japan
      • Hiroshima, Japan
      • Hitachi, 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
      • Nagasaki, Japan
      • Nagoya, Japan
      • Narashino, Japan
      • Nishinomiya, Japan
      • Ohta-Ku, Japan
      • Oita, Japan
      • Osaka, Japan
      • Osaka-City, Japan
      • Osaki, Japan
      • Sagamihara, Japan
      • Saitama, Japan
      • Sapporo, Japan
      • Sasebo, Japan
      • Sendai, Japan
      • Sendai N/A, Japan
      • Shimotsuga, Japan
      • Shimotsuke, Japan
      • Shinjuku, Japan
      • Shinjuku-Ku, Japan
      • Shizuoka, Japan
      • Suita, Japan
      • Tokorozawa, Japan
      • Tokushima N/A, Japan
      • Tokyo, Japan
      • Tokyo N/A, 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 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 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
Placebo Comparator: Placebo + methotrexate
Drug: Methotrexate (MTX)
6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.
Drug: Placebo
Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 24.
Experimental: CNTO 148 50 mg + methotrexate
Drug: CNTO 148
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 152.
Other Names:
  • Golimumab
Drug: Methotrexate (MTX)
6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.
Experimental: CNTO 148 100 mg + methotrexate
Drug: Methotrexate (MTX)
6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ACR 20% response
Time Frame: Week 14
Week 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)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (Estimate)

August 5, 2008

Study Record Updates

Last Update Posted (Estimate)

May 23, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR015340
  • JNS012-JPN-03 (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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