Full Text View
Tabular View
No Study Results Posted
Related Studies
Study Registry to Evaluate the Long-Term Safety of Infliximab and Clinical Status of Pediatric Patients With Inflammatory Bowel Disease.
This study is currently recruiting participants.
Verified by Centocor, Inc., February 2009
First Received: January 21, 2008   Last Updated: February 27, 2009   History of Changes
Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00606346
  Purpose

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 Phase
Crohn's Disease
Inflammatory Bowel Diseases
Ulcerative Colitis
Phase IV

Study Type: Observational
Study Design: Prospective
Official Title: A Multicenter, Prospective, Long-Term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Estimated Enrollment: 5000
Study Start Date: May 2007
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, 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.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Crohn's disease
  • Ulcerative Colitis, or Indeterminate Colitis for at least 2 months

Exclusion Criteria:

  • 17 years of age or older
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606346

Contacts
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

  Show 33 Study Locations
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Additional Information:
No publications provided

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

Keywords provided by Centocor, Inc.:
TNF-alpha
Indeterminate Colitis
Crohn's Disease
Immunomodulators
infliximab
Inflammatory Bowel Diseases
Ulcerative Colitis

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 03, 2009