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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00261976 |
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Date of registration:
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02/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Long-term Safety Study of Infliximab (Remicade)
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Scientific title:
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Long-term Safety Follow-up of REMICADE (RESULTS) |
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Date of first enrolment:
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February 2002 |
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Target sample size:
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2971 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00261976 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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Argentina
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Austria
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Belgium
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Canada
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Denmark
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Finland
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France
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Germany
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Hungary
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Ireland
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Israel
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Netherlands
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Norway
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Poland
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Spain
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Sweden
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Centocor, Inc. 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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Centocor, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients enrolled in ongoing and future Centocor sponsored infliximab clinical
studies that require long-term safety follow-up (ie, primary studies). Patients must
have received at least 1 dose of study agent to be eligible for participation in the
study
Exclusion Criteria:
- Did not previously participate in Centocor sponsored infliximab clinical studies.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Psoriasis
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Arthritis, Rheumatoid
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Intervention(s)
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Drug: Infliximab (Remicade)
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Primary Outcome(s)
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Number of patients with each of the following long-term safety events
[Time Frame: Five years]
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Secondary Outcome(s)
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Number of patients with malignancies by malignancy type
[Time Frame: Five years]
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Number of patients with serious infections by type of infection
[Time Frame: Five years]
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Secondary ID(s)
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C0168T45
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CR004780
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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