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

Sponsor

Janssen Biotech, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT00606346

Collaborator

(none)

4,970

Enrollment

Locations

373

Anticipated Duration (Months)

78.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease Ulcerative Colitis Indeterminate Colitis Inflammatory Bowel Diseases	Biological: Anti TNF therapy including infliximab Drug: No Biologics

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

4970 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 31, 2007

Anticipated Primary Completion Date :

Nov 15, 2037

Anticipated Study Completion Date :

Jun 30, 2038

Arms and Interventions

Arm	Intervention/Treatment
Anti TNF therapy including infliximab Treatments will be prescribed according to investigator judgement.	Biological: Anti TNF therapy including infliximab Treatments will be prescribed according to investigator judgement.
No Biologics Treatments will be prescribed according to investigator judgement.	Drug: No Biologics Treatments will be prescribed according to investigator judgement.

Arm

Intervention/Treatment

Anti TNF therapy including infliximab

Treatments will be prescribed according to investigator judgement.

Biological: Anti TNF therapy including infliximab

Treatments will be prescribed according to investigator judgement.

No Biologics

Treatments will be prescribed according to investigator judgement.

Drug: No Biologics

Treatments will be prescribed according to investigator judgement.

Outcome Measures

Primary Outcome Measures

Obtain long-term safety and clinical status information on pediatric patients with IBD (ie, CD, UC, or indeterminate colitis [IC]). [This is a 20-year registry that has visits every 6 months.]
The objective of this registry is to obtain long-term safety and clinical status information on pediatric patients with IBD (ie, CD, UC, or IC).

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country
1	Mobile	Alabama	United States
2	Phoenix	Arizona	United States
3	Beverly Hills	California	United States
4	Los Angeles	California	United States
5	Oakland	California	United States
6	Sacramento	California	United States
7	San Diego	California	United States
8	San Francisco	California	United States
9	Aurora	Colorado	United States
10	Hartford	Connecticut	United States
11	New Haven	Connecticut	United States
12	Gainesville	Florida	United States
13	Miami	Florida	United States
14	Orlando	Florida	United States
15	Atlanta	Georgia	United States
16	Boise	Idaho	United States
17	Chicago	Illinois	United States
18	Lexington	Kentucky	United States
19	New Orleans	Louisiana	United States
20	Portland	Maine	United States
21	Boston	Massachusetts	United States
22	Newton	Massachusetts	United States
23	Worcester	Massachusetts	United States
24	Detroit	Michigan	United States
25	Southfield	Michigan	United States
26	Minneapolis	Minnesota	United States
27	Rochester	Minnesota	United States
28	Boys Town	Nebraska	United States
29	Las Vegas	Nevada	United States
30	Manchester	New Hampshire	United States
31	Mays Landing	New Jersey	United States
32	Morristown	New Jersey	United States
33	Bronx	New York	United States
34	Brooklyn	New York	United States
35	Buffalo	New York	United States
36	Lake Success	New York	United States
37	Mineola	New York	United States
38	New York	New York	United States
39	Stony Brook	New York	United States
40	Syracuse	New York	United States
41	Williamsville	New York	United States
42	Chapel Hill	North Carolina	United States
43	Durham	North Carolina	United States
44	Oklahoma City	Oklahoma	United States
45	Danville	Pennsylvania	United States
46	Philadelphia	Pennsylvania	United States
47	Greenville	South Carolina	United States
48	Knoxville	Tennessee	United States
49	Memphis	Tennessee	United States
50	Dallas	Texas	United States
51	Fort Worth	Texas	United States
52	San Antonio	Texas	United States
53	Burlington	Vermont	United States
54	Charlottesville	Virginia	United States
55	Fairfax	Virginia	United States
56	Norfolk	Virginia	United States
57	Seattle	Washington	United States
58	Madison	Wisconsin	United States
59	Milwaukee	Wisconsin	United States
60	Edmonton	Alberta	Canada
61	Halifax	Nova Scotia	Canada
62	Dundas	Ontario	Canada
63	Toronto	Ontario	Canada