Zymfentra (Infliximab-dyyb) Real World Cohort Study for Crohn's Disease and Ulcerative Colitis

What this Trial Is About

Researchers are evaluating the real-world effectiveness of Zymfentra (Infliximab-dyyb) in treating adults with Crohn's disease, ulcerative colitis, or inflammatory bowel disease unclassified. This observational study aims to understand if Zymfentra reduces symptoms over one year by collecting patient-reported information on bowel habits and disease activity. The study is sponsored by the University of North Carolina, Chapel Hill. Participants are adults who are prescribed Zymfentra as part of their usual medical care, either starting treatment or switching from other infliximab therapies. The study involves following patients for one year while they continue their standard intravenous infliximab induction or maintenance therapy. No experimental treatments are assigned, as this is an observational study. Participants will complete online surveys at multiple time points over the year to report symptoms and disease activity using tools like the Simple Clinical Colitis Activity Index and Simple Crohn's Disease Activity Index. Additional assessments include endoscopic scores, calprotectin levels, and patient-reported outcome measures on fatigue, anxiety, depression, social satisfaction, urgency, quality of life, and work productivity. Data is collected at intervals ranging from baseline up to 52 weeks, with a focus on clinical remission and response to treatment.

Zymfentra (Infliximab-dyyb) REal World Cohort STudy