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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: |
NCT00724529 |
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Date of registration:
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25/07/2008 |
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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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Post Marketing Surveillance of Remicade
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Scientific title:
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Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD) |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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938 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00724529 |
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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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Korea, Republic of
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Contacts
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Name:
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Janssen Korea, Ltd., Korea 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 Korea, Ltd., Korea |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Severe active Crohn's disease: the patients with severe active Crohn's disease who do
not show any response to the treatment with corticosteroid or immunosuppressive
agents, have no drug tolerance, or are contraindicated to such treatments.
- Fistula-type active Crohn's disease: the patients with fistula-type active Crohn's
disease who do not show any response to general treatments such as antibiotics,
drainage, or immunosuppressant.
- Ankylosing spondylitis: the patients with ankylosing spondylitis who do not show
adequate response to general treatments, and with increased serological indices
related to severe axial symptoms and inflammation.
Exclusion Criteria:
- None
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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Ankylosing Spondylitis
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Crohn's Disease
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Intervention(s)
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Biological: Infliximab
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Primary Outcome(s)
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To evaluate the safety of Remicade Injection (Infliximab) when used in clinical practice
[Time Frame: The maximum period for observation in this surveillance would be 30 weeks (6 administrations) for patients with Crohn's disease and 24~30 weeks (6 administrations) for patients with Ankylosing spondylitis.]
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Secondary Outcome(s)
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To evaluate the efficacy of Remicade Injection (Infliximab) when used in clinical practice
[Time Frame: The maximum period for observation in this surveillance would be 30 weeks (6 administrations) for patients with Crohn's disease and 24~30 weeks (6 administrations) for patients with Ankylosing spondylitis.]
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Secondary ID(s)
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REMICADECRD4015
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CR100771
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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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