Actively Recruiting
Zymfentra (Infliximab-dyyb) REal World Cohort STudy
Led by University of North Carolina, Chapel Hill · Updated on 2026-03-17
200
Participants Needed
5
Research Sites
154 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
C
Celltrion
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Zymfentra (Infliximab-dyyb) REal World Cohort STudy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients age 18 years or older with Crohn's disease, ulcerative colitis, or Inflammatory Bowel Disease Unclassified
- Starting Zymfentra at week 10 following standard intravenous induction therapy at weeks 0, 2, and 6, or switching from infliximab originator or biosimilars during maintenance to Zymfentra
- Expected to be followed by the participating center for 12 months
- Diagnosis based on standard clinical, radiographic, endoscopic, and histologic criteria including symptoms such as diarrhea, rectal bleeding, abdominal pain, fever, complicated perianal disease, extraintestinal manifestations, weight loss, or failure to thrive
- Symptoms present on two or more occasions separated by at least 8 weeks or ongoing symptoms for at least 6 weeks
- Objective evidence of inflammation by endoscopy, radiology, or histology as specified in the study guidelines
- Classification into Crohn's disease, ulcerative colitis, or Inflammatory Bowel Disease Unclassified based on detailed diagnostic criteria
You will not qualify if you...
- Unable to provide informed consent
- Non-English speaking
- Patients presenting for a one-time consultation only
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
2
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
New York University
New York, New York, United States, 10016
Actively Recruiting
5
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7080
Actively Recruiting
Research Team
S
Susan Jackson
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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