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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

October 10, 2008
May 23, 2013
May 2008
October 2011   (final data collection date for primary outcome measure)
ACR 20% response [ Time Frame: Weel 14 ] [ Designated as safety issue: No ]
ACR 20% response
Complete list of historical versions of study NCT00771251 on ClinicalTrials.gov Archive Site
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 ]
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)
Not Provided
Not Provided
 
A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • 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
    Intervention: Drug: CNTO 148
  • Experimental: CNTO 148 100 mg
    Intervention: Drug: CNTO 148
  • Experimental: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
311
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00771251
CR015343
No
Janssen Pharmaceutical K.K.
Janssen Pharmaceutical K.K.
Mitsubishi Tanabe Pharma Corporation
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
Janssen Pharmaceutical K.K.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP