Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease

Completed

• Conditions: Crohn´s Disease

• Registration Number: NCT03890445
• Lead Sponsor: Sandoz

Brief Summary

Hyrimoz™ was developed as a biosimilar to HumiraTM (INN: adalimumab) and Zessly™ was developed as a biosimilar to RemicadeTM (INN: infliximab). Within the Biosimilar Development Program of Hyrimoz™ and Zessly™, two clinical confirmatory efficacy and safety studies were conducted: Hyrimoz™ in plaque psoriasis and Zessly™ in rheumatoid arthritis. Both confirmatory Phase III studies demonstrated equivalent efficacy and similar safety and immunogenicity of Hyrimoz™ to HumiraTM and Zessly™ to RemicadeTM, respectively.

The current study is designed to provide a systematic and consistent overview of the real-world data in biologic-naïve patients with moderate-to-severe Crohn's disease (CD). The data collected in this observational trial will be used to increase the knowledge of the effectiveness of Hyrimoz™ and Zessly™ in clinical routine care in patients with moderate-to-severe CD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Study Start: 2019-06-24
• Primary Completion: 2020-05-08
• Study Completion: 2020-05-08
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients in corticosteroid-free remission defined as HBI (Harvey-Bradshow Index) ≤ 4 at Week 52	week 52	This is a prospective, observational study that does not impose a therapy protocol, diagnostic or therapeutic procedure, or a visit schedule. Patients will be treated according to the local prescribing information, and routine medical practice in terms of visit frequency and types of assessments performed; only these data will be collected as part of the study.

Secondary Outcome Measures

Name	Time	Method
Time to progression of a composite endpoint	6 years	Composite endpoint defined as the occurrence of one of the following events : * Disease-related surgery, or; * Disease-related hospital admission for \> 3 days (including treatment-related side effects), or; * Serious disease-related complications
Incidence of adverse events	6 years	• Incidence of Adverse Events (AE) in patients receiving Hyrimoz™ or Zessly™
Therapy persistence and treatment adherence (measured by the number of dose interruptions of Hyrimoz™ or Zessly™ without drug holidays more than 4 months).	4 years	Observational study
Measurement of the Inflamatory Bowel Disease (IBD) index over an observation period	4 years
Assessing correlation of the diagnostic and treatment-monitoring procedures (imaging procedures and disease-related laboratory parameters) in patients receiving Hyrimoz™ or Zessly™ over an observation period	4 years
Assessing QoL (Quality of Life scale) of patients receiving Hyrimoz™ or Zessly™ over an observation period	4 years

Trial Locations

Locations (1)

Sandoz Investigational Site; 🇸🇪 Orebro, Sweden