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A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease (DEVELOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606346
Recruitment Status : Active, not recruiting
First Posted : February 1, 2008
Last Update Posted : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the long-term safety and clinical status of pediatric patients with Inflammatory Bowel Disease (IBD). Particular attention will be directed to recording safety outcomes reported in association with infliximab and other prescribed IBD therapies. In addition, information on disease status and quality of life will be collected.

Condition or disease Intervention/treatment
Crohn's Disease Ulcerative Colitis Indeterminate Colitis Inflammatory Bowel Diseases Biological: Anti TNF therapy including infliximab Drug: No Biologics

Detailed Description:
This registry study will include volunteer pediatric patients: approximately 2,000 pediatric patients with Crohn's Disease who have been treated with infliximab and approximately 2,000 pediatric patients with Crohn's Disease who have received therapies other than infliximab. Approximately 1,000 pediatric patients with Ulcerative Colitis or Indeterminant Colitis will also be enrolled. All patient treatments for IBD will be decided by the treating physicians in consultation with their patients based on usual clinical practice. Patient information will be collected at the time of enrollment and every 6 months for approximately 20 years. Data collection will include disease characteristics, IBD medications, safety assessments to include adverse events. Patients will also be asked to complete a brief questionnaire describing school and/or work attendance in order to assess quality of life. Some patients may be asked to participate in a substudy that will evaluate blood levels of formation of proteins that may develop after treatment with infliximab. A small amount of additional blood may be taken at the time of a routine blood draw that is part of a patient's routine medical care as determined by a treating physician. There are three studies as part of the post marketing requirement for IBD - C0168Z02, REMICADEPIB4002 and REMICADEPIB4003. There is one combined database for these protocols and analyses are performed using the aggregate data. All reports and publications will be generated from the combined database. No study agents will be administered in this registry. All patients will receive standard-of-care treatments prescribed by the patient's physician.
Study Design
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Study Type : Observational
Actual Enrollment : 4970 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
Actual Study Start Date : May 31, 2007
Estimated Primary Completion Date : November 15, 2037
Estimated Study Completion Date : June 30, 2038

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Anti TNF therapy including infliximab
Treatments will be prescribed according to investigator judgement.
 Biological: Anti TNF therapy including infliximab
Treatments will be prescribed according to investigator judgement.
No Biologics
Treatments will be prescribed according to investigator judgement.
 Drug: No Biologics
Treatments will be prescribed according to investigator judgement.


Outcome Measures
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Primary Outcome Measures :
  1. Obtain long-term safety and clinical status information on pediatric patients with IBD (ie, CD, UC, or indeterminate colitis [IC]). [ Time Frame: This is a 20-year registry that has visits every 6 months. ]
    The objective of this registry is to obtain long-term safety and clinical status information on pediatric patients with IBD (ie, CD, UC, or IC).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a registry of pediatric patients with IBD (e.g., CD, UC, or IC in C0168Z02 and CD in REMICADEPIB4002 and REMICADEPIB4003) who were treated with infliximab and/or other medical therapies for IBD. Information will be collected on patient demographics, disease characteristics, clinical status, quality of life, medications, and dose and frequency of administration of infliximab, other biologics, and immune modulators.
Criteria

Inclusion Criteria:

C0168Z02 - Confirmed diagnosis of Crohn's disease, Ulcerative Colitis, or Indeterminate Colitis for at least 2 months 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).

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.

REMICADEPIB4002 and REMICADEPIB4003: Confirmed diagnosis of Crohn's disease or Ulcerative Colitis for at least 2 months

Exclusion Criteria:

C0168Z02: 17 years of age or older, with the exception of patients who participated in the Sponsor's conducted pediatric IBD clinical trials.

Have other Crohn's-like diseases that are associated with genetic diseases (eg, glycogen storage disease).

The patient and parent/guardian are not able to adhere to the protocol requirements.

Are participating in any clinical trial for an investigational agent that is not commercially available.

REMICADEPIB4002 and REMICADEPIB4003: Less than 6 years of age or 17 years of age or older.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606346


Locations
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Sponsors and Collaborators
Janssen Biotech, Inc.
Investigators
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Study Director: Janssen Services, L.L.C. Clinical Trial Janssen Services, L.L.C.
More Information
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Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT00606346    
Other Study ID Numbers: CR013912
C0168Z02 ( Other Identifier: Janssen Biotech INC. )
REMICADEPIB4002 ( Other Identifier: Janssen Biotech INC. )
REMICADEPIB4003 ( Other Identifier: Janssen Biotech INC. )
First Posted: February 1, 2008    Key Record Dates
Last Update Posted: June 1, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Biotech, Inc.:
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
Inflammatory Bowel Diseases
 Immunomodulators
infliximab
TNF-alpha
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Colonic Diseases
Infliximab
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents