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Study Registry to Evaluate the Long-term Safety of Infliximab and Clinical Status of Pediatric Patients With Inflammatory Bowel Disease
This study is currently recruiting participants.
Verified January 2012 by Centocor Ortho Biotech Services, L.L.C.

First Received on January 21, 2008.   Last Updated on January 31, 2012   History of Changes
Sponsor: Centocor Ortho Biotech Services, L.L.C.
Information provided by: Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier: NCT00606346
  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
Inflammatory Bowel Diseases
Drug: conventional systemic agents
Biological: infliximab
Biological: Biological therapies other than infliximab
Phase IV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 Centocor Ortho Biotech Services, L.L.C.:

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 ]

Estimated Enrollment: 4900
Study Start Date: May 2007
Estimated Study Completion Date: December 2035
Groups/Cohorts Assigned Interventions
001
infliximab as prescribed
Biological: infliximab
as prescribed
002
Biological therapies other than infliximab as prescribed
Biological: Biological therapies other than infliximab
as prescribed
003
conventional systemic agents as prescribed
Drug: conventional systemic agents
as prescribed

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:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This is a registry of pediatric patients with IBD (e.g., CD, UC, or IC in C0168Z02 and CD in REMICADEPIB4002 and REMICADEPIB4003) who were treated with infliximab and/or other medical therapies for IBD. Information will be collected on patient demographics, disease characteristics, clinical status, quality of life, medications, and dose and frequency of administration of infliximab, other biologics, and immune modulators.

Criteria

Inclusion Criteria:

  • C0168Z02 - Confirmed diagnosis of Crohn's disease
  • Ulcerative Colitis, or Indeterminate Colitis for at least 2 months
  • REMICADEPIB4002 and REMICADEPIB4003: Confirmed diagnosis of Crohn's disease for at least 2 months

Exclusion Criteria:

  • C0168Z02: 17 years of age or older. REMICADEPIB4002 and REMICADEPIB4003: Less than 6 years of age or 17 years of age or older.
  Contacts and Locations
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 55 Study Locations
Sponsors and Collaborators
Centocor Ortho Biotech Services, L.L.C.
Investigators
Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial Centocor Ortho Biotech Services, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Leader, Worldwide Medical Affairs Immunology, Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier: NCT00606346     History of Changes
Other Study ID Numbers: CR013912, C0168Z02, REMICADEPIB4002, REMICADEPIB4003
Study First Received: January 21, 2008
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Centocor Ortho Biotech Services, L.L.C.:
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
Inflammatory Bowel Diseases
Immunomodulators
infliximab
TNF-alpha

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012