Celltrion | YU-MATTER | IBD & RIC | e-cohort

The YU-MATTER study is a patient-centered e-cohort designed to assess overall patient satisfaction with the injection of Yuflyma (a biosimilar of adalimumab) three months after the first injection, compared to their experience with their previous adalimumab treatment. Patient preferences and experience can impact adherence and persistence with a treatment, particularly during a treatment switch, but the exact dimensions of these factors have been little explored until now. This study, combining qualitative sociology with quantitative data collection, began with a sociological study that identified the key dimensions of patient experience and satisfaction to be investigated within the e-cohort.

Study start: Q2 2022
Study end: Q3 2023

Alsinova’s role: Providing full-service CRO support for 15 months to manage a cohort of patients in gastroenterology and rheumatology, with a target of 300 patients across five diseases. This included protocol drafting, co-facilitation of the scientific committee, regulatory submission, contracting, site initiation and monitoring, e-CRF and e-PRO development, data management, statistical analyses, results dissemination, and weekly coordination with the sponsor’s teams for site monitoring (MSL), among other tasks.