A-MORE - Elocta Observational Study
Research type
Research Study
Full title
A 48-Month, Multi-Centre, Observational Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
IRAS ID
276336
Contact name
Stefan Lethagen
Contact email
Sponsor organisation
Swedish Orphan Biovitrum AB (publ)
Clinicaltrials.gov Identifier
44740, NIHR CPMS Number; NCT04293523, ClinicalTrials.gov identifier
Duration of Study in the UK
5 years, 7 months, 31 days
Research summary
This is a 48-month observational, prospective, multicentre study. The overall aim of the study is to evaluate the long-term outcome of Elocta treatment on joint health, in patients treated prophylactically with Elocta in a real-world setting. The study plans to enrol approximately 300 adult and paediatric patients at 70 sites in Europe and the Middle East. To be eligible, a patient should be diagnosed with haemophilia A and prescribed factor treatment with Elocta according to usual clinical practice (standard of care). Choice of treatment will not be dictated by the study protocol. Eligible patients who choose to participate in this observational study, will be enrolled and followed for up to four years during their routine clinic visits. Available data on bleeding (including joint bleeds), joint surgery and factor VIII plasma levels will be collected during the observation period. In addition, participants (or their caregivers) will complete questionnaires on participants' physical activity, work productivity, and quality of life, as applicable. The total study duration is planned to be 66 months (5.5 years), including an 18-month recruitment period and a 48-month (4 year) follow-up period for each participant. This study is sponsored by Swedish Orphan Biovitrum AB (Sobi).
REC name
East of England - Essex Research Ethics Committee
REC reference
20/EE/0117
Date of REC Opinion
10 Jun 2020
REC opinion
Further Information Favourable Opinion