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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2013 |
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Main ID: |
NCT00771251 |
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Date of registration:
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10/10/2008 |
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Primary sponsor: |
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Public title:
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A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
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Scientific title:
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A Study of Golimumab (CNTO148) Monotherapy in Patients With Active Rheumatoid Arthritis |
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Date of first enrolment:
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May 2008 |
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Target sample size:
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311 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00771251 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Janssen Pharmaceutical K.K. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Pharmaceutical K.K. |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: CNTO148 ; Golimumab
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Primary Outcome(s)
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ACR 20% response
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Secondary Outcome(s)
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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)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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