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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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EUCTR |
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Last refreshed on:
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23 May 2012 |
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Main ID: |
EUCTR2008-006484-36-IT |
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Date of registration:
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24/04/2009 |
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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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MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE AND
ANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION IN
PEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE
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Scientific title:
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MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE AND
ANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION IN
PEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE |
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Date of first enrolment:
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16/04/2009 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006484-36 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: yes
Other specify the comparator: Terapia nutrizionale
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. diagnosis of CD made at least 3 months before the enrolment; 2. disease activity score in the moderate-to-severe range; 3. ability to start oral formula for nutritional therapy.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Fistulizing and/or anorectal CD, stenosing CD, pre-existing systemic disease, hepatic or renal dysfunction, lung disease, systemic infection, suspected pregnancy.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Moderate-to-severe active Crohn`s
disease.
MedDRA version: 9.1
Level: LLT
Classification code 10011398
Term: Crohn's
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Intervention(s)
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Trade Name: REMICADE
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: INFLIXIMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
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Primary Outcome(s)
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Main Objective: The proportion of patients with both clinical remission and intestinal mucosa healing (as documented by endoscopy and histology) at the end of the induction phase, as well as at the end of maintaining remission phase
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Secondary Objective: the mean changes in clinical and laboratory indexes of disease activity, the mean change in anthropometric parameters, the safety profile and the costs of the two
treatment regimens, and finally, changes in the intestinal mucosa expression of pro-inflammatory cytokines.
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Primary end point(s): The study aims at comparing the efficacy of nutritional therapy alone (a polymeric formula given orally,
without adding any drug) with biological therapy (intravenous infusions of a chimeric monoclonal antibody anti-TNFalpha) in inducing and maintaining remission in children with moderate-to-severe active Crohn`s
disease (CD).
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Secondary ID(s)
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FARM79YXLN
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Source(s) of Monetary Support
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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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