NCT00606346Active, not recruiting
A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 4970 (actual)
- First submitted
- 21 Jan 2008
- Start date
- 31 May 2007
- Primary completion date
- 15 Nov 2037
- Lead sponsor
- Janssen Biotech, Inc.
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT00606346
What you commit to
- Study type: Observational
- Participants enrolled: 4970
- From 31 May 2007 to the primary completion date, 15 Nov 2037
- 62 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are participating in any clinical trial for an investigational agent that is not commercially available.
Other illness
- Have other Crohn's-like diseases that are associated with genetic diseases (eg, glycogen storage disease).
Age
- C0168Z02: 17 years of age or older, with the exception of patients who participated in the Sponsor's conducted pediatric IBD clinical trials.
- REMICADEPIB4002 and REMICADEPIB4003: Less than 6 years of age or 17 years of age or older.
Other
- The patient and parent/guardian are not able to adhere to the protocol requirements.
Who the study is looking for
- 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
Age in the registry: 1 month to 17 years · Sex: All · Does not accept healthy volunteers
Sites (62)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.