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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01752790 |
Date of registration:
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12/12/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy and Safety of Top-down Therapy in Pediatric Crohn's Disease
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Scientific title:
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Efficacy and Safety of Infliximab as First-line Therapy in Pediatric Crohn's Disease: a Randomized, Controlled, Open-label Trial |
Date of first enrolment:
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December 2012 |
Target sample size:
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0 |
Recruitment status: |
Withdrawn |
URL:
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http://clinicaltrials.gov/show/NCT01752790 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Contacts
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Name:
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Marina Aloi, Investigator |
Address:
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Telephone:
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Email:
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Affiliation:
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Sapienza University of Rome |
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Key inclusion & exclusion criteria
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Inclusion Criteria
1. diagnosis of CD,
2. PCDAI>30,
3. duration of disease less than 1 yr from the time of diagnosis (early CD).
Exclusion Criteria:
1. any prior treatment with immunosuppressive agents (AZA/6-MP, methotrexate,
cyclosporine) or anti-TNFa,
2. stenosing CD,
3. pre-existing systemic disease,
4. hepatic or renal dysfunction,
5. systemic infection,
6. suspected pregnancy,
7. history of active or past tuberculosis,
8. contraindication to steroid therapy
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pediatric Crohn's Disease
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Intervention(s)
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Drug: Step-up
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Drug: Top-down
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Primary Outcome(s)
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Clinical response or clinical remission as determined by PCDAI in top-down vs. step-up group
[Time Frame: 6, 12, 18, 24, 36 months]
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Rate of mucosal healing in top-down vs. step-up group
[Time Frame: 6, 12, 24, 36 months]
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Secondary Outcome(s)
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Hospitalization and surgery
[Time Frame: 6,12,24, 36 months]
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Growth
[Time Frame: 6,12,24,36 months]
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Rate of adverse events in top-down vs. step-up group
[Time Frame: 6,12,18,24,36 months]
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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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