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RecruitingNCT07237516

Zymfentra (Infliximab-dyyb) REal World Cohort STudy

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Trial Parameters

ConditionUlcerative Colitis (UC)
SponsorUniversity of North Carolina, Chapel Hill
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment200
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-11-20
Completion2028-11-03

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Brief Summary

The goal of this observational study is to learn about how effective Zymfentra (IFX=dyyb) is when treating patients with Crohn's disease (CD) and ulcerative colitis (UC) Does Zymfentra lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed Zymfentra (IFX-dyyb as part of their regular medical care for CD or UC will answer online survey questions about their bowel habits for 1 year.

Eligibility Criteria

Inclusion Criteria: \- 1. Adult patients, age 18 years or older, with Crohn's disease (CD), ulcerative colitis (UC) or Inflammatory Bowel Disease Unclassified (IBDU), who are either starting Zymfentra at week 10 (IFX-dyyb) in the setting of standard-of-care initiation with intravenous Infliximab (IFX) originator or IFX biosimilars induction therapy at weeks 0,2,6 or switching from intravenous IFX originator or IFX biosimilars during maintenance therapy to Zymfentra (IFX-dyyb) 2. Anticipation that the patient will be followed by the participating center for the next 12 months. 3\. Diagnosis of CD, UC or IBDU must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below. The following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with CD, UC or IBDU: A) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, com

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