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NCT00207688 · ClinicalTrials.gov registry record
A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients
A clinical trial, sponsored by Janssen Research & Development.
- Completed
- Registry status
- 505
- Enrollment target
NCT00207688: Completed study, sponsored by Janssen Research & Development.
NCT00207688 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 505 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00207688 has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- 505 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.
Primary Outcome
Long-term safety will be evaluated by assessment of serious infections,new malignancies (including colorectal cancer), new autoimmune diseases, death, delayed hypersensitivity (serum sickness-like) reactions, or dysplasia of the colon and other non-serious adverse events. Non-serious adverse events will be collected for participants continuing at the beginning of collection of non-serious adverse events.
Interventions
- DRUG Placebo
- DRUG Infliximab 5 mg/kg
- DRUG Infliximab 10 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 505 participants |
| Start Date | 2004-08-31 |
| Est. Completion | 2015-09-09 |
What the finished NCT00207688 record still lists
NCT00207688 is an observational study that tracks outcomes without assigning an intervention. The registered 505 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00207688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00207688 about?
NCT00207688 is a clinical study titled "A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients". The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.
What is the current status of trial NCT00207688?
This trial is currently completed. The enrollment target is 505 participants. The study started on 2004-08-31. Estimated completion is 2015-09-09.
What interventions are being tested in trial NCT00207688?
The interventions under investigation include: Placebo (DRUG), Infliximab 5 mg/kg (DRUG), Infliximab 10 mg/kg (DRUG).
Who is sponsoring clinical trial NCT00207688?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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