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A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
NCT00606346 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Anti TNF therapy including infliximab
- DRUG No Biologics
Study Locations (20)
California
- — Los Angeles
- — Oakland
- — Sacramento
- — San Diego
- — San Francisco
Florida
- — Gainesville
- — Miami
- — Orlando
Connecticut
- — Hartford
- — New Haven
Alabama
- — Mobile
Arizona
- — Phoenix
Colorado
- — Aurora
Georgia
- — Atlanta
Idaho
- — Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,970 participants |
| Start Date | 2007-05-31 |
| Est. Completion | 2038-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00606346
The ClinicalTrials.gov registry entry for NCT00606346 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,970 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Biotech, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions — of which Anti TNF therapy including infliximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00606346 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00606346 about?
NCT00606346 is a clinical study titled "A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease". 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, i...
What is the current status of trial NCT00606346?
This trial is currently active not recruiting. The enrollment target is 4,970 participants. The study started on 2007-05-31. Estimated completion is 2038-06-30.
What conditions does trial NCT00606346 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Diseases, Indeterminate Colitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00606346?
The interventions under investigation include: Anti TNF therapy including infliximab (BIOLOGICAL), No Biologics (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00606346?
This trial is sponsored by Janssen Biotech, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00606346 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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