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

Launched by JANSSEN BIOTECH, INC. · Jan 21, 2008

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and health status of children and teenagers with inflammatory bowel diseases (IBD), which include conditions like Crohn's disease and ulcerative colitis. Researchers want to learn more about how well treatments, particularly a medication called infliximab, work over time and how these conditions affect the patients' quality of life. The study is currently active but not looking for new participants at this time.

To be eligible for the trial, a child or teenager must have been diagnosed with Crohn's disease, ulcerative colitis, or a similar condition for at least two months. They should be scheduled to see their doctor at least every six months for regular check-ups. Unfortunately, those who are 17 years old or older (unless they participated in earlier trials) or younger than 6 years old won’t be able to join. Participants can expect regular follow-ups with their healthcare providers, and their experiences will help researchers understand how to improve care for kids with IBD.

Gender

ALL

Eligibility 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.