Zymfentra for Crohn's Disease and Ulcerative Colitis
This observational study is looking at how well Zymfentra (infliximab-dyyb) works for adults with Crohn's disease (CD) or ulcerative colitis (UC). Zymfentra is a medication used to treat these conditions. The study wants to see if Zymfentra helps reduce your symptoms over one year. If you are starting Zymfentra as part of your regular medical care, you might be able to join. Success in this study means seeing an improvement in your symptoms, which will be measured by surveys about your bowel habits over 52 weeks. The current status of this study is unclear, and it plans to enroll about 200 people.
- Study design
- This is an observational study, meaning researchers will watch how Zymfentra works in about 200 participants as part of their regular care. It is not a randomized or blinded study.
- What's involved
- You will answer online survey questions about your bowel habits for one year, at specific times like weeks 0, 1, 2, 4, 6, 10, 14, 18, 24, 36, and 52.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 52 weeks (one year) after starting Zymfentra.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Zymfentra (Infliximab-dyyb) REal World Cohort STudy
At a glance
Conditions
Where it's being run
11 sites across 8 statesStudy leadership
- Hans Herfarth, MD, PhD · PRINCIPAL_INVESTIGATOR · University of North Carolina
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Clinical remission as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52.
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.
- Clinical remission as evaluated by the Simple Crohn's Disease Activity Index (sCDAI for the patient-reported outcomes.Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52
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.