COMPACT, version 1.0
Research type
Research Study
Full title
A multicenter, prospective, observational cohort study to evaluate the real-world safety and effectiveness of Erelzi™, an etanercept biosimilar (COMPACT)
IRAS ID
233652
Contact name
Dr. Charlotte Both
Contact email
Sponsor organisation
Hexal AG, Biopharmaceuticals Clinical Development
Clinicaltrials.gov Identifier
MUSC 35714, NIHR
Duration of Study in the UK
3 years, 8 months, 1 days
Research summary
Research Summary
The purpose of the COMPACT study is to gather information about the use of the medication Erelzi™ in routine medical care in patients suffering from Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis. The study will collect data on the duration of the treatment with Erelzi™ as well as on effectiveness, safety and quality of life. This is an observational research study which will collect data on participants treated in accordance with routine medical care and will not involve any study specific interventions. If a patient's medical treatment is changed during the study then data as per routine medical care will continue to be collected until the study is completed.
Only patients meeting all eligibility criteria and who have started treatment with Erelzi™ may be invited to be observed in the study. For each eligible participant, written informed consent must be obtained prior to any study related activities.
About 2.900 participants in Europe, Canada, US, Latin America and Asia Pacific worldwide, aged 18 years and over, will take part in the study. The expected duration of the study for each participant is approximately 3 years (minimum 2 years and maximum four years). In the UK the maximum will be under 4 years as the end date is 15Sep2021.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0481
Date of REC Opinion
24 Jan 2018
REC opinion
Further Information Favourable Opinion