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| 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 |
| 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
|
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 |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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| Study Director: | Centocor Ortho Biotech Services, L.L.C. Clinical Trial | Centocor Ortho Biotech Services, L.L.C. |
More Information
| 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 |
|
Crohn's Disease Ulcerative Colitis Indeterminate Colitis Inflammatory Bowel Diseases |
Immunomodulators infliximab TNF-alpha |
|
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 |