A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
DEVELOP
2 other identifiers
observational
4,970
2 countries
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2007
Longer than P75 for all trials
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2007
CompletedFirst Submitted
Initial submission to the registry
January 21, 2008
CompletedFirst Posted
Study publicly available on registry
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2037
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2038
April 13, 2026
April 1, 2026
30.5 years
January 21, 2008
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Obtain long-term safety and clinical status information on pediatric patients with IBD (ie, CD, UC, or indeterminate colitis [IC]).
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).
This is a 20-year registry that has visits every 6 months.
Study Arms (2)
Anti TNF therapy including infliximab
Treatments will be prescribed according to investigator judgement.
No Biologics
Treatments will be prescribed according to investigator judgement.
Interventions
Treatments will be prescribed according to investigator judgement.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Oakland, California, United States
Unknown Facility
Sacramento, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Lexington, Kentucky, United States
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New Orleans, Louisiana, United States
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Portland, Maine, United States
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Boston, Massachusetts, United States
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Newton, Massachusetts, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Southfield, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Boys Town, Nebraska, United States
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Las Vegas, Nevada, United States
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Manchester, New Hampshire, United States
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Mays Landing, New Jersey, United States
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Morristown, New Jersey, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Lake Success, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Stony Brook, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Williamsville, New York, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Danville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Greenville, South Carolina, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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San Antonio, Texas, United States
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Burlington, Vermont, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
Unknown Facility
Burlington, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Services, L.L.C. Clinical Trial
Janssen Services, L.L.C.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2008
First Posted
February 1, 2008
Study Start
May 31, 2007
Primary Completion (Estimated)
November 15, 2037
Study Completion (Estimated)
June 30, 2038
Last Updated
April 13, 2026
Record last verified: 2026-04