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NCT02503514 · ClinicalTrials.gov registry record
Autoimmune Paradoxical Reactions in IBD Longitudinal Cohort
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 380
- Enrollment target
NCT02503514: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT02503514 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 380 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02503514 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 380 participants
- Enrollment target
Study Summary
Purpose: Inflammatory bowel disease patients undergoing treatment with varying biologic agents will be evaluated for incidences of paradoxical immune reactions, the risk factors associated with those paradoxical immune reactions, and whether the paradoxical immune reactions and their associated risk factors differ based on formulation of biologic agent. Participants: All adults (≥18 year) with confirmed IBD on a biologic agent or with plans to initiate treatment in 1 month Procedures (methods): Subjects undergoing treatment with a biologic agent will be followed indefinitely for paradoxical immune reactions. Data will be collected at baseline as well as serum and plasma for banking. Subjects will be followed at 6 month intervals either via email, telephone interviews or at the time of clinic follow-up visits. In the event of a de-novo paradoxical reaction, specific information will be collected from sites in an event capture form, with data abstracted from routine clinical care for the paradoxical reaction. Subjects will continue to be followed every 3 months after the event via email, telephone contact to determine whether resolution and/or recurrence occurred, and to determine any changes in medical therapy. Serum and plasma will be re-collected at the time of first event for comparison to baseline samples and to samples from controls (those on biologics without study documented paradoxical immune reactions). At resolution of the event, patient will return to 6 month follow up schedule. Subjects can discontinue and/or fail a particular biologic treatment; therefore they will also be followed for paradoxical immune reactions, on any new biologic treatment they undergo while in the study.
Primary Outcome
Investigator will assess autoimmune reactions such as skin lesions (psoriasis), vasculitis, demyelinating disorders or drug-induced lupus in patients on biologic therapies for IBD. These reactions have been described as "paradoxical inflammation."
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2015-08 |
| Est. Completion | 2017-08 |
What the finished NCT02503514 record still lists
NCT02503514 is an observational study that tracks outcomes without assigning an intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02503514 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02503514 about?
NCT02503514 is a clinical study titled "Autoimmune Paradoxical Reactions in IBD Longitudinal Cohort". Purpose: Inflammatory bowel disease patients undergoing treatment with varying biologic agents will be evaluated for incidences of paradoxical immune reactions, the risk factors associated with those paradoxical immune reactions, and whether the paradoxical immune reactions and their associated risk...
What is the current status of trial NCT02503514?
This trial is currently completed. The enrollment target is 380 participants. The study started on 2015-08. Estimated completion is 2017-08.
Who is sponsoring clinical trial NCT02503514?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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