Autoimmune Paradoxical Reactions in IBD Longitudinal Cohort
Completed
Conditions studied: Inflammatory Bowel Diseases, Crohns Disease, Ulcerative Colitis, Colitis
In brief
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.
Key facts
- Study ID
- NCT02503514
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 380
- Starts
- 2015-08-01
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2017-12-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Ability to understand and sign informed consent.
- Adults (male or female) with confirmed IBD diagnosed by routine clinical, radiographic, endoscopic and pathological criteria.
- Adults age 18 or older.
- Adults on a new biologic agent or with plans to initiate a biologic agent, within 1 month for the treatment of their IBD.
You may not qualify if…
- Inability to understand and sign informed consent.
- Inability to confirm diagnosis of IBD from medical records
- Inability to confirm time of initial biologic start, and prior specific formulations from medical records.
Where it is running
- University of North Carolina at Chapel Hill- CGIBD — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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