Zymfentra (Infliximab-dyyb) REal World Cohort STudy

NCT07237516 | Recruiting

• 1 other identifier: 25-2184
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Crohn's Disease (CD); Ulcerative Colitis (UC); Indeterminate Colitis; Inflammatory Bowel Disease (IBD)

Keywords

Zymfentra; ZEST

Outcome Measures

Primary Outcomes (2)

• Clinical remission as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.

  The SCCAI is a 6-item that describes the symptoms and disease activity of a patient with UC at the time of assessment. A score of 0-4 is considered a clinical range of remission (but with more refined definitions of clinical remission with SCCAI ≤2 and very mild symptoms with a score \>2 ≤4), 5-7 mild activity, 8-16 moderate activity and \> 16 severe activity. A response will be defined as a decrease of the SCCAI score \< 5 points in patients with a baseline SCCAI ≥5.

  Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52.

• Clinical remission as evaluated by the Simple Crohn's Disease Activity Index (sCDAI for the patient-reported outcomes.

  The Short Crohn's Disease Activity Index (sCDAI) is a simplified version of the Crohn's Disease Activity Index (CDAI), used to assess disease severity in Crohn's disease patients. It reduces the number of variables required, making it easier and quicker to use in clinical practice. Recent data demonstrated, that collections of the parameters on a single day equally reflects reliable disease activity compared to a collection of data over 7 consecutive days, which is often hampered by missing data. A score of \< 150, 150-219, 220-450 and \>450 reflects remission, mild, moderate and severe Crohn's disease activity.

  Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52

Secondary Outcomes (10)

• Response as measured by the Simple Endoscopic Score for Crohn's disease (SES-CD)

  Through study completion, an average of 1 year

• Response as measured by the endoscopic Mayo score for ulcerative colitis

  Through study completion, an average of 1 year

• Mucosal healing will be assessed in the setting of standard-of-care calprotectin levels.

  Weeks 0, 14, 24, and 52.

• Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS)- Depression

  Weeks 0, 24, and 52.

• Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) -Anxiety Score

  Weeks 0, 24, and 52.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with UC, CD, or IBDU starting Zymfentra (Infliximab-dyyb) in the setting of standard-of-care

You may qualify if:

• \- 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.
• \. 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, complicated perianal disease, extraintestinal manifestations, weight loss or failure to thrive.
• AND B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration. When there has been a single episode of colitis (in some instances less than 6 weeks duration) resulting in colectomy and resolution of disease symptoms, pathology on the colectomy specimen should be consistent with idiopathic IBD and microbiology studies should be negative.
• AND
• C) One or more of the following providing objective evidence of inflammation:
• Endoscopic: Mucosal edema, erythema, loss of normal submucosal vasculature, friability, ulceration, stricture formation, pseudopolyps, mucosal edema, erythema. Where there are only minor changes (mucosal edema, erythema, loss of normal submucosal vasculature, friability) mucosal biopsies should have been done to confirm the presence of IBD.
• Radiologic: Mucosal thickening and/or nodularity, ulceration, stricture, pseudopolyps, fistula formation, pseudosacculation. Minor changes alone (mucosal thickening and/or nodularity) should not be sufficient to make a diagnosis of IBD.
• Histologic: Mucosal erosion or ulceration, architectural changes of crypts, Paneth cell metaplasia (in colon), transmural inflammatory infiltrate\*, fibrosis of muscularis propria\*, noncaseating granuloma\*.
• \* CD
• Individuals with IBD should be classified into one of three categories, based on most recent diagnosis:
• Crohn's disease (CD):
• Evidence of small intestinal inflammation with endoscopically, radiologically or histologically demonstrated ulcerations, fistulation, mucosal fissuring, nodularity or cobblestoning, stricture formation or histologically demonstrated transmural inflammation with or without granuloma formation.
• Isolated esophageal, gastric or duodenal inflammation with the finding of noncaseating granuloma.

You may not qualify if:

• Patients will be excluded if they meet any of the following criteria:
• Inability to provide informed consent.
• Non-English speaking
• Patients presenting for a one-time consultation.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Celltrion: collaborator

Study Sites (5)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Mercy Medical Center

Baltimore, Maryland, 21202, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

New York University

New York, New York, 10016, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599-7080, United States

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Hans Herfarth, MD, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Jackson

CONTACT

919-843-9071; susan_jackson@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 19, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 3, 2028
• Study Completion (Estimated): November 3, 2028
• Last Updated: March 17, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 36 months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (5)