Autoimmune Paradoxical Reactions in IBD Longitudinal Cohort

NCT02503514 | Completed

• 1 other identifier: 15-0167
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases; Crohns Disease; Ulcerative Colitis; Colitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants with specific paradoxical Adverse Events Using Biologic therapies as a part of routine care for the treatment of IBD

  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."

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with confirmed IBD on a biologic agent or with plans to initiate this within 1 month.

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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill- CGIBD

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (27)

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Biospecimen

Retention: SAMPLES WITH DNA

Subjects will have blood drawn (10 mL EDTA tube, 10mL Serum Separator, and a 6 mL EDTA tube)at their baseline visit. If a subject experiences a paradoxical reaction they will a repeat of the blood draw done at their baseline visit.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases

Study Officials

• Millie D Long, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 21, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 7, 2017

Record last verified: 2017-12

Locations

US (1)