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

This study has been completed.
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00771251
First received: October 10, 2008
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: CNTO 148
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Golimumab (CNTO148) Monotherapy in Patients With Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • ACR 20% response [ Time Frame: Weel 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 311
Study Start Date: May 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Golimumab
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771251

  Show 72 Study Locations
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00771251     History of Changes
Other Study ID Numbers: CR015343
Study First Received: October 10, 2008
Last Updated: May 23, 2013
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Keywords provided by Janssen Pharmaceutical K.K.:
Rheumatoid arthritis
Fully Human anti-TNFa monoclonal antibody
CNTO148
Golimumab

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014