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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: EUCTR
Last refreshed on: 7 December 2015
Main ID:  EUCTR2008-005237-30-NL
Date of registration: 18/08/2009
Prospective Registration: Yes
Primary sponsor: Janssen Biologics B.V.
Public title: A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis
Scientific title: A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP
Date of first enrolment: 01/12/2009
Target sample size: 6000
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005237-30
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Registry including both patients with and without Infliximab treatment (other therapies) If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: IBD medications other than infliximab Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Canada Netherlands Sweden United States
Contacts
Name: Site manager   
Address:  27 rue de la Villette 69003 Lyon France
Telephone: +334 72355317
Email: cberaudiat@mapigroup.com
Affiliation:  MAPI
Name: Site manager   
Address:  27 rue de la Villette 69003 Lyon France
Telephone: +334 72355317
Email: cberaudiat@mapigroup.com
Affiliation:  MAPI
Key inclusion & exclusion criteria
Inclusion criteria:
1. Have a confirmed diagnosis of CD for at least 2 months.
2. Are male or female at least 6 years of age, but less than 17 years of age with the exception of patients who participated in the Sponsor's protocol C0168T72 or C0168T62. These patients are eligible for enrollment regardless of the patients age at the time of enrollment
3. The parent/legal guardian must be capable of providing written
informed consent, and assent should be obtained from the child according to local regulations (age at which assent is given may vary by the IRB or EC).
4. The patient's physician expects the patient to be scheduled for a
medical encounter (and/or other direct contact) at least every 6 months, as part of their usual care, at the time of enrollment.


Are the trial subjects under 18? yes
Number of subjects for this age range: 6000
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:
Patients meeting any of the following criteria may not be enrolled in the
registry:
1. Are less than 6 years of age or 17 years of age or older with the exception of patients who participated in the Sponsor's protocol C0168T72 or C0168T62. These patients are eligible for enrollment regardless of the patients age at the time of enrollment
2. The patient and parent/guardian are not able to adhere to the
protocol requirements.
3. Have other Crohn's-like diseases that are associated with genetic
diseases (eg, glycogen storage disease).
4. Are participating in any clinical trial for an investigational agent that
is not commercially available.
5. Are currently participating in one of the Sponsor's trials for pediatric IBD.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Pediatric patients with a confirmed diagnosis of CD or UC .
MedDRA version: 18.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Remicade
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Other descriptive name: Remsima and Inflectra
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: The objective of this registry is to obtain long-term safety and clinical
status information on pediatric patients with IBD (CD or UC).
Primary end point(s): Not applicable
Secondary Objective: Not applicable
Timepoint(s) of evaluation of this end point: Not applicable
Secondary Outcome(s)
Secondary end point(s): Not applicable
Timepoint(s) of evaluation of this end point: Not applicable
Secondary ID(s)
REMICADEPIB4002
Source(s) of Monetary Support
Janssen Biologics BV
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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