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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.
Last refreshed on: 19 February 2015
Main ID:  NCT01752790
Date of registration: 12/12/2012
Prospective Registration: Yes
Primary sponsor: University of Roma La Sapienza
Public title: Efficacy and Safety of Top-down Therapy in Pediatric Crohn's Disease
Scientific title: Efficacy and Safety of Infliximab as First-line Therapy in Pediatric Crohn's Disease: a Randomized, Controlled, Open-label Trial
Date of first enrolment: December 2012
Target sample size: 0
Recruitment status: Withdrawn
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Name:     Marina Aloi, Investigator
Affiliation:  Sapienza University of Rome
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Pediatric Crohn's Disease
Drug: Step-up
Drug: Top-down
Primary Outcome(s)
Clinical response or clinical remission as determined by PCDAI in top-down vs. step-up group [Time Frame: 6, 12, 18, 24, 36 months]
Rate of mucosal healing in top-down vs. step-up group [Time Frame: 6, 12, 24, 36 months]
Secondary Outcome(s)
Growth [Time Frame: 6,12,24,36 months]
Hospitalization and surgery [Time Frame: 6,12,24, 36 months]
Rate of adverse events in top-down vs. step-up group [Time Frame: 6,12,18,24,36 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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