Last updated on November 2018

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


Brief description of study

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.

Detailed Study 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, safety assessments to include adverse events. 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. There are three studies as part of the post marketing requirement for IBD - C0168Z02, REMICADEPIB4002 and REMICADEPIB4003. There is one combined database for these protocols and analyses are performed using the aggregate data. All reports and publications will be generated from the combined database. No study agents will be administered in this registry. All patients will receive standard-of-care treatments prescribed by the patient's physician.

Clinical Study Identifier: NCT00606346

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South Alabama Medical Science Foundation

South Alabama Medical Science Foundation
Mobile, AL United States

Phoenix Children's Hospital

Phoenix Children's Hospital
Phoenix, AZ United States

Cedars-Sinai Medical Center

Cedars-Sinai Medical Center
Beverly Hills, CA United States

Childrens Hospital

Childrens Hospital
Los Angeles, CA United States

UCLA Medical Center

UCLA Medical Center
Los Angeles, CA United States

Childrens Hospital Oakland

Childrens Hospital Oakland
Oakland, CA United States

California Pacific MC

California Pacific MC
Sacramento, CA United States

Rady Childrens Hospital-San Diego

Rady Childrens Hospital-San Diego
San Diego, CA United States

UCSF Pediatric GI

UCSF Pediatric GI
San Francisco, CA United States

Childrens Hospital/Clinical Trials Organization

Childrens Hospital/Clinical Trials Organization
Aurora, CO United States

Connecticut Children's - Medical Center

Connecticut Children's - Medical Center
Hartford, CT United States

Yale University School Of Medicine

Yale University School Of Medicine
New Haven, CT United States

University of Florida College of ...

University of Florida College of Medicine
Gainesville, FL United States

Pediatric Gastroenterology Associates

Pediatric Gastroenterology Associates
Miami, FL United States

Nemours Children's Clinic - Orlando ...

Nemours Children's Clinic - Orlando of the Nemours Foundation
Orlando, FL United States

Arnold Palmer Hospital For Children

Arnold Palmer Hospital For Children
Orlando, FL United States

Emory University

Emory University
Atlanta, GA United States

Children's Center for Digestive Healthcare

Children's Center for Digestive Healthcare
Atlanta, GA United States

St. Luke's Regional Medical Center ...

St. Luke's Regional Medical Center Ltd
Boise, ID United States

University of Chicago

University of Chicago
Chicago, IL United States

Mapi

Mapi
Lexington, KY United States

University of Kentucky

University of Kentucky
Lexington, KY United States

Childrens Hospital of New Orleans

Childrens Hospital of New Orleans
New Orleans, LA United States

Maine Medical Center

Maine Medical Center
Portland, ME United States

Tufts-New England Medical Center

Tufts-New England Medical Center
Boston, MA United States

Mass General Hospital

Mass General Hospital
Newton, MA United States

U Mass Memorial Childrens Medical ...

U Mass Memorial Childrens Medical Center
Worcester, MA United States

Childrens Hospital Of Michigan

Childrens Hospital Of Michigan
Detroit, MI United States

Tolia Pediatric GI Center

Tolia Pediatric GI Center
Southfield, MI United States

University Of Minnesota

University Of Minnesota
Minneapolis, MN United States

Minnesota Gastroenterology Associates

Minnesota Gastroenterology Associates
Minneapolis, MN United States

Mayo Clinic

Mayo Clinic
Rochester, MN United States

Boys Town Peds Gi

Boys Town Peds Gi
Boys Town, NE United States

Pediatric Gastroenterology And Nutrition

Pediatric Gastroenterology And Nutrition
Las Vegas, NV United States

Elliot Health System

Elliot Health System
Manchester, NH United States

South Jersey Pediatric G I

South Jersey Pediatric G I
Mays Landing, NJ United States

Goryeb Childrens Hospital

Goryeb Childrens Hospital
Morristown, NJ United States

Downstate Medical Center

Downstate Medical Center
Brooklyn, NY United States

Maimonides Medical Center

Maimonides Medical Center
Brooklyn, NY United States

University Pediatric Associates Inc.

University Pediatric Associates Inc.
Buffalo, NY United States

Ccmc Steven and Alexandra Cohen ...

Ccmc Steven and Alexandra Cohen Children'S Medical Center of New York
Lake Success, NY United States

Winthrop University Hospital Department of ...

Winthrop University Hospital Department of rheumatology, Allergy & Immunology
Mineola, NY United States

New York Presbyterian - Weill ...

New York Presbyterian - Weill Cornell
New York, NY United States

Use link at the bottom ...

Columbia University Medical Center
New York, NY United States

State University of New York ...

State University of New York at Stony Brook
Stony Brook, NY United States

Golisano Children's Hospital

Golisano Children's Hospital
Syracuse, NY United States

Montefiore Medical Center

Montefiore Medical Center
The Bronx, NY United States

Maya Devi Srivastava, MD

Maya Devi Srivastava, MD
Williamsville, NY United States

University of North Carolina Hospital

University of North Carolina Hospital
Chapel Hill, NC United States

Duke University Medical Center

Duke University Medical Center
Durham, NC United States

Childrens Hospital of Oklahoma

Childrens Hospital of Oklahoma
Oklahoma City, OK United States

Geisinger Medical Center

Geisinger Medical Center
Danville, PA United States

Children's Hospital of Philadelphia

Children's Hospital of Philadelphia
Philadelphia, PA United States

Center For Digestive Health Systems-Greenville

Center For Digestive Health Systems-Greenville
Greenville, SC United States

East Tenessee Children's Hospital - ...

East Tenessee Children's Hospital - GI FOR KIDS, PLLC
Knoxville, TN United States

Memphis Pediatric Gastroenterology

Memphis Pediatric Gastroenterology
Memphis, TN United States

Childrens Medical Center of Dallas

Childrens Medical Center of Dallas
Dallas, TX United States

Cook Childrens Medical Center

Cook Childrens Medical Center
Fort Worth, TX United States

University of Texas Health Science ...

University of Texas Health Science Center at San Antonio
San Antonio, TX United States

Fletcher Allen Health Care - ...

Fletcher Allen Health Care - Vermont Childrens Hospital
Burlington, VT United States

University of Virginia Pediatric Gastroenterolgy

University of Virginia Pediatric Gastroenterolgy
Charlottesville, VA United States

Pediatric Specialists Of Virginia

Pediatric Specialists Of Virginia
Falls Church, VA United States

Childrens Specialty Group

Childrens Specialty Group
Norfolk, VA United States

Swedish Pediatric Specialty Care

Swedish Pediatric Specialty Care
Seattle, WA United States

Seattle Childrens Hospital

Seattle Childrens Hospital
Seattle, WA United States

University of Wisconsin At Madison

University of Wisconsin At Madison
Madison, WI United States

Medical College Of Wisconsin

Medical College Of Wisconsin
Milwaukee, WI United States

Aberthart Centre

Aberthart Centre
Edmonton, AB Canada

Iwk Health Centre

Iwk Health Centre
Halifax, NS Canada

Mapi DTP Canada

Mapi DTP Canada
Dundas, ON Canada

Hospital For Sick Children

Hospital For Sick Children
Toronto, ON Canada

Montreal Children's Hospital

Montreal Children's Hospital
Montreal, QC Canada

Recruitment Status: Closed


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