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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Janssen Biotech, Inc.
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT00606346
First received: January 21, 2008
Last updated: November 13, 2014
Last verified: November 2014
  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.


Condition Intervention Phase
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
Inflammatory Bowel Diseases
Biological: Anti TNF therapy including infliximab
Drug: No Biologics
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:
  • Obtain long-term safety and clinical status information on pediatric patients with IBD (ie, CD, UC, or indeterminate colitis [IC]). [ Time Frame: This is a 20-year registry that has visits every 6 months. ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 5000
Study Start Date: May 2007
Estimated Study Completion Date: December 2035
Estimated Primary Completion Date: December 2035 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Active Comparator: No Biologics
Treatments will be prescribed according to investigator judgement.
Drug: No Biologics
Treatments will be prescribed according to investigator judgement.

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.

  Eligibility

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606346

Contacts
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: JNJ.CT@sylogent.com

  Show 60 Study Locations
Sponsors and Collaborators
Janssen Biotech, Inc.
Investigators
Study Director: Janssen Services, L.L.C. Clinical Trial Janssen Services, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT00606346     History of Changes
Other Study ID Numbers: CR013912, C0168Z02, REMICADEPIB4002, REMICADEPIB4003
Study First Received: January 21, 2008
Last Updated: November 13, 2014
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by Janssen Biotech, Inc.:
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
Inflammatory Bowel Diseases
Immunomodulators
infliximab
TNF-alpha

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Colitis
Colitis, Ulcerative
Crohn Disease
Intestinal Diseases
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Pathologic Processes
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014