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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 October 2017 |
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Main ID: |
NCT01438151 |
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Date of registration:
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20/09/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's Disease
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Scientific title:
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Association of Serum Infliximab and Antibodies Toward Infliximab (ATI) to Clinical Outcomes in Crohn's Disease |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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11 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01438151 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Lloyd Mayer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Name:
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Shradha Agarwal, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with active (HBI >10) refractory inflammatory and/or perianal fistulizing
Crohn's disease who are prescribed infliximab as standard of care by their
gastroenterologist.
Exclusion Criteria:
- Pregnant women.
Age minimum:
7 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: Remicade
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Primary Outcome(s)
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Remicade Dose Escalation
[Time Frame: 2/16/12-3/22/13]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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