Clinical Trial Details

NCT ID: NCT00606346
Date Last Changed: August 8, 2017


Research Study Summary

A Phase 4 clinical study for patients with Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis or Inflammatory Bowel Diseases

Research Study Title

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


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.

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Recruitment Details

1 to 17 Years
Overall Status
Lead Sponsor
Janssen Biotech, Inc.
373 Months
Facility Type


All ages 1 Month to 17 Years

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.

Site Locations (54)

Country State City Zip Facility and Contact
United States Alabama Mobile 36604 South Alabama Medical Science Foundation
United States Arizona Phoenix 85016 Phoenix Children's Hospital
United States California Beverly Hills 90211 Cedars-Sinai Medical Center
United States California Los Angeles 90027 Childrens Hospital
United States California Oakland 94609 Childrens Hospital Oakland
United States California San Diego 92123 Rady Childrens Hospital-San Diego
United States California San Francisco 94143 UCSF Pediatric GI
United States Colorado Aurora 80045 Childrens Hospital/Clinical Trials Organization
United States Connecticut Hartford 06106 Connecticut Children's - Medical Center
United States Connecticut New Haven 06520 Yale University School Of Medicine
United States Florida Orlando 32806 Arnold Palmer Hospital For Children
United States Georgia Atlanta 30322 Emory University
United States Georgia Atlanta 30342 Children's Center for Digestive Healthcare
United States Illinois Chicago 60637 University of Chicago
United States Louisiana New Orleans 70118 Childrens Hospital of New Orleans
United States Maine Portland 04102 Maine Medical Center
United States Massachusetts Boston 02111 Tufts-New England Medical Center
United States Massachusetts Boston 02135 Boston Clinical Trials
United States Massachusetts Newton 02462 Mass General Hospital
United States Massachusetts Worcester 01655 U Mass Memorial Childrens Medical Center
United States Michigan Detroit 48201 Childrens Hospital Of Michigan
United States Minnesota Minneapolis 55454 University Of Minnesota
United States Minnesota Minneapolis Minnesota Gastroenterology Associates
United States Minnesota Rochester 55905 Mayo Clinic
United States Nebraska Boys Town 60810 Boys Town Peds Gi
United States New Jersey Morristown 07962 Goryeb Childrens Hospital
United States New York Brooklyn 11203 Downstate Medical Center
United States New York Brooklyn 11219 Maimonides Medical Center
United States New York Buffalo 14222 University Pediatric Associates Inc.
United States New York Lake Success 11042 Ccmc Steven and Alexandra Cohen Children'S Medical Center of New York
United States New York Mineola 11501 Winthrop University Hospital Department of rheumatology, Allergy & Immunology
United States New York New York 10021 New York Presbyterian - Weill Cornell
United States New York New York 10032 Columbia University Medical Center
United States New York Stony Brook 11794 State University of New York at Stony Brook
United States North Carolina Chapel Hill 27514 University of North Carolina Hospital
United States North Carolina Durham 27710 Duke University Medical Center
United States Oklahoma Oklahoma City 73104 Childrens Hospital of Oklahoma
United States Pennsylvania Danville 17822 Geisinger Medical Center
United States Pennsylvania Philadelphia 19104 Children's Hospital of Philadelphia
United States South Carolina Greenville 29615 Center For Digestive Health Systems-Greenville
United States Tennessee Knoxville 37916 East Tenessee Children's Hospital - GI FOR KIDS, PLLC
United States Texas Dallas 75207 Childrens Medical Center of Dallas
United States Texas Fort Worth 76104 Cook Childrens Medical Center
United States Vermont Burlington 05401 Fletcher Allen Health Care - Vermont Childrens Hospital
United States Virginia Falls Church 22042 Pediatric Specialists Of Virginia
United States Virginia Norfolk 23507 Childrens Specialty Group
United States Washington Seattle 98104 Swedish Pediatric Specialty Care
United States Washington Seattle 98105 Seattle Childrens Hospital
United States Wisconsin Madison 53792 University of Wisconsin At Madison
United States Wisconsin Milwaukee 53226 Medical College Of Wisconsin
Canada Alberta Edmonton T6G 2J3 Aberthart Centre
Canada Nova Scotia Halifax B3K 6R8 Iwk Health Centre
Canada Ontario Dundas L9H 7P3 Mapi DTP Canada
Canada Ontario Toronto M5G 1X8 Hospital For Sick Children


Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:


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