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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 27 May 2013
Main ID:  NCT00771251
Date of registration: 10/10/2008
Primary sponsor: Janssen Pharmaceutical K.K.
Public title: A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
Scientific title: A Study of Golimumab (CNTO148) Monotherapy in Patients With Active Rheumatoid Arthritis
Date of first enrolment: May 2008
Target sample size: 311
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00771251
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  
Countries of recruitment
Contacts
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 74 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: CNTO 148
Drug: Placebo
Primary Outcome(s)
ACR 20% response [Time Frame: Weel 14]
Secondary Outcome(s)
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]
Secondary ID(s)
CR015343
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Mitsubishi Tanabe Pharma Corporation
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