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Home » Clinical Trials » Ulcerative Colitis

Clinical Trial Details

Overview

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

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.

To Learn more
Phase

4

Gender

Both Male and Female

Age

1 to 17 Years

Overall Status

Recruiting

Lead Sponsor

Janssen Biotech, Inc.

Duration

343 Months

Facility Type

N/A

Eligibility

Both Male and Female 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 (48)

Country State City Zip Facility and Contact
United States Alabama Mobile Research Site
United States Arizona Phoenix Research Site
United States California Francisco Research Site
United States California Los Angeles Research Site
United States California Oakland Research Site
United States California San Diego Research Site
United States Colorado Denver Research Site
United States Connecticut Hartford Research Site
United States Connecticut New Haven Research Site
United States Florida Gainesville Research Site
United States Florida Orlando Research Site
United States Georgia Atlanta Research Site
United States Idaho Boise Research Site
United States Illinois Chicago Research Site
United States Louisiana New Orleans Research Site
United States Maine Portland Research Site
United States Massachusetts Boston Research Site
United States Massachusetts Worcester Research Site
United States Michigan Detroit Research Site
United States Minnesota Minneapolis Research Site
United States Minnesota Rochester Research Site
United States Minnesota Saint Paul Research Site
United States Nebraska Boys Town Research Site
United States New Hampshire Manchester Research Site
United States New Jersey Morristown Research Site
United States New York Brooklyn Research Site
United States New York Buffalo Research Site
United States New York Mineola Research Site
United States New York New Hyde Park Research Site
United States New York New York Research Site
United States New York Stony Brook Research Site
United States North Carolina Chapel Hill Research Site
United States North Carolina Durham Research Site
United States Oklahoma Oklahoma City Research Site
United States Pennsylvania Danville Research Site
United States Pennsylvania Philadelphia Research Site
United States South Carolina Greenville Research Site
United States Tennessee Knoxville Research Site
United States Tennessee Memphis Research Site
United States Texas Dallas Research Site
United States Texas Fort Worth Research Site
United States Vermont Burlington Research Site
United States Virginia Charlottesville Research Site
United States Virginia Fairfax Research Site
United States Virginia Norfolk Research Site
United States Washington Seattle Research Site
United States Wisconsin Madison Research Site
United States Wisconsin Milwaukee Research Site

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:

E-mail:

NCT ID: NCT00606346

Date Last Changed: August 7, 2014

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