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

Last updated: September 11, 2025
Sponsor: Janssen Biotech, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Colic

Inflammatory Bowel Disease

Treatment

Anti TNF therapy including infliximab

No Biologics

Clinical Study ID

NCT00606346
CR013912
REMICADEPIB4003
REMICADEPIB4002
C0168Z02
  • Ages 1-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 4970
Treatment Group(s): 2
Primary Treatment: Anti TNF therapy including infliximab
Phase:
Study Start date:
May 31, 2007
Estimated Completion Date:
June 30, 2038

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.

Connect with a study center

  • Aberthart Centre

    Edmonton, Alberta T6G 2J3
    Canada

    Site Not Available

  • Edmonton, Alberta
    Canada

    Site Not Available

  • Edmonton 5946768, Alberta 5883102
    Canada

    Site Not Available

  • empty

    Lexington, KY
    Canada

    Site Not Available

  • empty

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • Halifax, Nova Scotia
    Canada

    Site Not Available

  • Halifax 6324729, Nova Scotia 6091530
    Canada

    Site Not Available

  • empty

    Burlington, Ontario
    Canada

    Site Not Available

  • Mapi DTP Canada

    Dundas, Ontario L9H 7P3
    Canada

    Site Not Available

  • Dundas, Ontario
    Canada

    Site Not Available

  • Hospital For Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • Burlington 5911592, Ontario 6093943
    Canada

    Site Not Available

  • Toronto 6167865, Ontario 6093943
    Canada

    Site Not Available

  • Montreal Children's Hospital

    Montreal, Quebec H3H 1P3
    Canada

    Site Not Available

  • South Alabama Medical Science Foundation

    Mobile, Alabama 36604
    United States

    Site Not Available

  • Mobile, Alabama
    United States

    Site Not Available

  • Mobile 4076598, Alabama 4829764
    United States

    Site Not Available

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Phoenix, Arizona
    United States

    Site Not Available

  • Phoenix 5308655, Arizona 5551752
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Beverly Hills, California 90211
    United States

    Site Not Available

  • empty

    Francisco, California
    United States

    Site Not Available

  • Childrens Hospital

    Los Angeles, California 90027
    United States

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • Childrens Hospital Oakland

    Oakland, California 94609
    United States

    Site Not Available

  • Oakland, California
    United States

    Site Not Available

  • California Pacific MC

    Sacramento, California 95817
    United States

    Site Not Available

  • Sacramento, California
    United States

    Site Not Available

  • Rady Childrens Hospital-San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • San Diego, California
    United States

    Site Not Available

  • UCSF Pediatric GI

    San Francisco, California 94143
    United States

    Site Not Available

  • San Francisco, California
    United States

    Site Not Available

  • Los Angeles 5368361, California 5332921
    United States

    Site Not Available

  • Oakland 5378538, California 5332921
    United States

    Site Not Available

  • Sacramento 5389489, California 5332921
    United States

    Site Not Available

  • San Diego 5391811, California 5332921
    United States

    Site Not Available

  • San Francisco 5391959, California 5332921
    United States

    Site Not Available

  • Childrens Hospital/Clinical Trials Organization

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Aurora, Colorado
    United States

    Site Not Available

  • empty

    Denver, Colorado
    United States

    Site Not Available

  • Aurora 5412347, Colorado 5417618
    United States

    Site Not Available

  • Connecticut Children's - Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Hartford, Connecticut
    United States

    Site Not Available

  • Yale University School Of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • New Haven, Connecticut
    United States

    Site Not Available

  • Hartford 4835797, Connecticut 4831725
    United States

    Site Not Available

  • New Haven 4839366, Connecticut 4831725
    United States

    Site Not Available

  • University of Florida College of Medicine

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Gainesville, Florida
    United States

    Site Not Available

  • Pediatric Gastroenterology Associates

    Miami, Florida 33155
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • Arnold Palmer Hospital For Children

    Orlando, Florida 32806
    United States

    Site Not Available

  • Orlando, Florida
    United States

    Site Not Available

  • Gainesville 4156404, Florida 4155751
    United States

    Site Not Available

  • Miami 4164138, Florida 4155751
    United States

    Site Not Available

  • Orlando 4167147, Florida 4155751
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Atlanta 4180439, Georgia 4197000
    United States

    Site Not Available

  • St. Luke's Regional Medical Center Ltd

    Boise, Idaho 83712
    United States

    Site Not Available

  • Boise, Idaho
    United States

    Site Not Available

  • Boise 5586437, Idaho 5596512
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Chicago, Illinois
    United States

    Site Not Available

  • Chicago 4887398, Illinois 4896861
    United States

    Site Not Available

  • Lexington, Kentucky
    United States

    Site Not Available

  • Lexington 4297983, Kentucky 6254925
    United States

    Site Not Available

  • Childrens Hospital of New Orleans

    New Orleans, Louisiana 70118
    United States

    Site Not Available

  • New Orleans, Louisiana
    United States

    Site Not Available

  • New Orleans 4335045, Louisiana 4331987
    United States

    Site Not Available

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Site Not Available

  • Portland, Maine
    United States

    Site Not Available

  • Portland 4975802, Maine 4971068
    United States

    Site Not Available

  • Tufts-New England Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Boston, Massachusetts
    United States

    Site Not Available

  • Mass General Hospital

    Newton, Massachusetts 02462
    United States

    Site Not Available

  • Newton, Massachusetts
    United States

    Site Not Available

  • U Mass Memorial Childrens Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Worcester, Massachusetts
    United States

    Site Not Available

  • Boston 4930956, Massachusetts 6254926
    United States

    Site Not Available

  • Newton 4945283, Massachusetts 6254926
    United States

    Site Not Available

  • Worcester 4956184, Massachusetts 6254926
    United States

    Site Not Available

  • Childrens Hospital Of Michigan

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Detroit, Michigan
    United States

    Site Not Available

  • Tolia Pediatric GI Center

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Southfield, Michigan
    United States

    Site Not Available

  • Detroit 4990729, Michigan 5001836
    United States

    Site Not Available

  • Southfield 5010636, Michigan 5001836
    United States

    Site Not Available

  • Minnesota Gastroenterology Associates

    Minneapolis, Minnesota
    United States

    Site Not Available

  • Minneapolis, Minnesota
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Rochester, Minnesota
    United States

    Site Not Available

  • Minnesota Gastroenterology Associates

    Saint Paul, Minnesota 55114
    United States

    Site Not Available

  • Minneapolis 5037649, Minnesota 5037779
    United States

    Site Not Available

  • Rochester 5043473, Minnesota 5037779
    United States

    Site Not Available

  • Boys Town Peds Gi

    Boys Town, Nebraska 60810
    United States

    Site Not Available

  • Boys Town, Nebraska
    United States

    Site Not Available

  • empty

    Boystown, Nebraska
    United States

    Site Not Available

  • Boys Town 5064510, Nebraska 5073708
    United States

    Site Not Available

  • Pediatric Gastroenterology And Nutrition

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Las Vegas, Nevada
    United States

    Site Not Available

  • Las Vegas 5506956, Nevada 5509151
    United States

    Site Not Available

  • Elliot Health System

    Manchester, New Hampshire 03109
    United States

    Site Not Available

  • Manchester, New Hampshire
    United States

    Site Not Available

  • Manchester 5089178, New Hampshire 5090174
    United States

    Site Not Available

  • South Jersey Pediatric G I

    Mays Landing, New Jersey 08330
    United States

    Site Not Available

  • Mays Landing, New Jersey
    United States

    Site Not Available

  • Goryeb Childrens Hospital

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • Morristown, New Jersey
    United States

    Site Not Available

  • Mays Landing 4502962, New Jersey 5101760
    United States

    Site Not Available

  • Morristown 5101427, New Jersey 5101760
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Bronx, New York
    United States

    Site Not Available

  • Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Brooklyn, New York
    United States

    Site Not Available

  • University Pediatric Associates Inc.

    Buffalo, New York 14222
    United States

    Site Not Available

  • Buffalo, New York
    United States

    Site Not Available

  • Ccmc Steven and Alexandra Cohen Children'S Medical Center of New York

    Lake Success, New York 11042
    United States

    Site Not Available

  • Lake Success, New York
    United States

    Site Not Available

  • Winthrop University Hospital Department of rheumatology, Allergy & Immunology

    Mineola, New York 11501
    United States

    Site Not Available

  • Mineola, New York
    United States

    Site Not Available

  • empty

    New Hyde Park, New York
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • State University of New York at Stony Brook

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Stony Brook, New York
    United States

    Site Not Available

  • Golisano Children's Hospital

    Syracuse, New York 13210
    United States

    Site Not Available

  • Syracuse, New York
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx, New York 10467
    United States

    Site Not Available

  • Maya Devi Srivastava, MD

    Williamsville, New York 14221
    United States

    Site Not Available

  • Williamsville, New York
    United States

    Site Not Available

  • Brooklyn 5110302, New York 5128638
    United States

    Site Not Available

  • Buffalo 5110629, New York 5128638
    United States

    Site Not Available

  • Lake Success 5123853, New York 5128638
    United States

    Site Not Available

  • Mineola 5127134, New York 5128638
    United States

    Site Not Available

  • New York 5128581, New York 5128638
    United States

    Site Not Available

  • Stony Brook 5139865, New York 5128638
    United States

    Site Not Available

  • Syracuse 5140405, New York 5128638
    United States

    Site Not Available

  • The Bronx 5110266, New York 5128638
    United States

    Site Not Available

  • Williamsville 5144588, New York 5128638
    United States

    Site Not Available

  • University of North Carolina Hospital

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Chapel Hill, North Carolina
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Durham, North Carolina
    United States

    Site Not Available

  • Chapel Hill 4460162, North Carolina 4482348
    United States

    Site Not Available

  • Durham 4464368, North Carolina 4482348
    United States

    Site Not Available

  • Childrens Hospital of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Oklahoma City 4544349, Oklahoma 4544379
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Danville, Pennsylvania
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Danville 5186327, Pennsylvania 6254927
    United States

    Site Not Available

  • Philadelphia 4560349, Pennsylvania 6254927
    United States

    Site Not Available

  • Center For Digestive Health Systems-Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Greenville, South Carolina
    United States

    Site Not Available

  • Greenville 4580543, South Carolina 4597040
    United States

    Site Not Available

  • East Tenessee Children's Hospital - GI FOR KIDS, PLLC

    Knoxville, Tennessee 37916
    United States

    Site Not Available

  • Knoxville, Tennessee
    United States

    Site Not Available

  • Memphis Pediatric Gastroenterology

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Memphis, Tennessee
    United States

    Site Not Available

  • Knoxville 4634946, Tennessee 4662168
    United States

    Site Not Available

  • Memphis 4641239, Tennessee 4662168
    United States

    Site Not Available

  • Childrens Medical Center of Dallas

    Dallas, Texas 75207
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • Cook Childrens Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Fort Worth, Texas
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • Dallas 4684888, Texas 4736286
    United States

    Site Not Available

  • Fort Worth 4691930, Texas 4736286
    United States

    Site Not Available

  • San Antonio 4726206, Texas 4736286
    United States

    Site Not Available

  • Burlington, Vermont
    United States

    Site Not Available

  • Burlington 5234372, Vermont 5242283
    United States

    Site Not Available

  • University of Virginia Pediatric Gastroenterolgy

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Charlottesville, Virginia
    United States

    Site Not Available

  • empty

    Fairfax, Virginia
    United States

    Site Not Available

  • Fairfax, Virginia
    United States

    Site Not Available

  • Pediatric Specialists Of Virginia

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Childrens Specialty Group

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Norfolk, Virginia
    United States

    Site Not Available

  • Charlottesville 4752031, Virginia 6254928
    United States

    Site Not Available

  • Fairfax 4758023, Virginia 6254928
    United States

    Site Not Available

  • Norfolk 4776222, Virginia 6254928
    United States

    Site Not Available

  • Seattle Childrens Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

  • Seattle 5809844, Washington 5815135
    United States

    Site Not Available

  • University of Wisconsin At Madison

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Madison, Wisconsin
    United States

    Site Not Available

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Milwaukee, Wisconsin
    United States

    Site Not Available

  • Madison 5261457, Wisconsin 5279468
    United States

    Site Not Available

  • Milwaukee 5263045, Wisconsin 5279468
    United States

    Site Not Available

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