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Sponsored by: |
Centocor, Inc. |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00606346 |
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.
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | A Multicenter, Prospective, Long-Term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease |
Estimated Enrollment: | 5000 |
Study Start Date: | May 2007 |
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, and safety assessments. 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.
No study agents will be administered in this registry. All patients will receive standard-of-care treatments prescribed by the patient's physician.
Ages Eligible for Study: | up to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
Study ID Numbers: | CR013912 |
Study First Received: | January 21, 2008 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00606346 History of Changes |
Health Authority: | United States: Institutional Review Board |
TNF-alpha Indeterminate Colitis Crohn's Disease Immunomodulators |
infliximab Inflammatory Bowel Diseases Ulcerative Colitis |
Crohn's Disease Infliximab Ileitis Gastrointestinal Diseases Enteritis Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Ileal Diseases Digestive System Diseases Crohn Disease Gastroenteritis Colitis |
Ileitis Gastrointestinal Diseases Enteritis Ulcer Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative |
Intestinal Diseases Ileal Diseases Pathologic Processes Digestive System Diseases Crohn Disease Gastroenteritis Colitis |