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

Phase

N/A

Condition

Ulcerative Colitis

Bowel Dysfunction

Crohn's Disease

Treatment

No Biologics

Anti TNF therapy including infliximab

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

No Biologics

May 31, 2007

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

Edmonton, Alberta
Canada
Site Not Available
Halifax, Nova Scotia
Canada
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Burlington, Ontario
Canada
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Dundas, Ontario
Canada
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Toronto, Ontario
Canada
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Mobile, Alabama
United States
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Phoenix, Arizona
United States
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Los Angeles, California
United States
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Oakland, California
United States
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Sacramento, California
United States
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San Diego, California
United States
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San Francisco, California
United States
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Aurora, Colorado
United States
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Hartford, Connecticut
United States
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New Haven, Connecticut
United States
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Gainesville, Florida
United States
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Miami, Florida
United States
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Orlando, Florida
United States
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Atlanta, Georgia
United States
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Boise, Idaho
United States
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Chicago, Illinois
United States
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Lexington, Kentucky
United States
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New Orleans, Louisiana
United States
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Portland, Maine
United States
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Boston, Massachusetts
United States
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Newton, Massachusetts
United States
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Worcester, Massachusetts
United States
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Detroit, Michigan
United States
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Southfield, Michigan
United States
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Minneapolis, Minnesota
United States
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Rochester, Minnesota
United States
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Boys Town, Nebraska
United States
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Las Vegas, Nevada
United States
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Manchester, New Hampshire
United States
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Mays Landing, New Jersey
United States
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Morristown, New Jersey
United States
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Bronx, New York
United States
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Brooklyn, New York
United States
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Buffalo, New York
United States
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Lake Success, New York
United States
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Mineola, New York
United States
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New York, New York
United States
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Stony Brook, New York
United States
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Syracuse, New York
United States
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The Bronx, New York
United States
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Williamsville, New York
United States
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Chapel Hill, North Carolina
United States
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Durham, North Carolina
United States
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Oklahoma City, Oklahoma
United States
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Danville, Pennsylvania
United States
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Philadelphia, Pennsylvania
United States
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Greenville, South Carolina
United States
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Knoxville, Tennessee
United States
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Memphis, Tennessee
United States
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Dallas, Texas
United States
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Fort Worth, Texas
United States
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San Antonio, Texas
United States
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Burlington, Vermont
United States
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Charlottesville, Virginia
United States
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Fairfax, Virginia
United States
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Norfolk, Virginia
United States
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Seattle, Washington
United States
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Madison, Wisconsin
United States
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Milwaukee, Wisconsin
United States
Site Not Available

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