NCT05633771

Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting

A Multicenter, International, Prospective, Non-interventional, Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 562 (estimated)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

An international, multicenter, non-interventional, prospective, post-authorization, descriptive, non-PASS, study.

Detailed description

The main purpose of this non-interventional study is to assess patient retention with Hyrimoz® treatment up to 6 months after treatment initiation in Inflammatory Bowel Disease (IBD) patients. Primary data will be collected at each data collection time point (visits will be according to local clinical practice). Data will be collected based on the information reported in the medical records. This study does not impose a therapy protocol, procedure or change in routine medical practice. Apart from self-administered questionnaires, no additional examinations or assessments are required, consequently there are no additional medical risks for the patients. The total duration of the study will be 36 months (3 years). The recruitment period will be for 2 years with individual patient follow-up for up to 1 year. It is expected that patients will visit their physicians at regular intervals depending on local specific clinical practices. Four time points for data collection will be defined: * T0 (patient inclusion in the study and Baseline characteristics). * T1 (3-month follow-up ± 1 month). * T2 (6-month follow-up and primary criteria -2/+3 months). * T3 (12-month follow-up -3/+2 months).

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
OTHER	Hyrimoz	There is no treatment allocation. Patients administered Hyrimoz by prescription that have started as routine medical treatment will be enrolled.

Timeline

• Start date: 2023-02-16
• Primary completion: 2025-12-15
• Completion: 2026-12-01
• First posted: 2022-12-01
• Last updated: 2026-01-12

Locations

51 sites across 2 countries: Belgium, France