A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
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A 48-Month, Multi-Centre, Observational Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
1 other identifier
observational
427
13 countries
41
Brief Summary
This is a 48-month observational, prospective, multicentre study. The overall aim of the study is to evaluate the long-term effectiveness of Elocta treatment on joint health in patients treated prophylactically with Elocta in a real-world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2020
CompletedStudy Start
First participant enrolled
March 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
March 19, 2026
March 1, 2026
6.3 years
February 20, 2020
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Joint health: Target joint development
Number of target joints
48 months
Joint health: Target joint resolution
Number of resolved target joints
48 months
Joint health: Target joint recurrence
Number of recurring target joints
48 months
Joint health: Annualised joint bleeding rate (AJBR) for treated bleeds
Number of joint bleeding events per year, for treated bleeds
48 months
Secondary Outcomes (3)
Disease Activity (hypertrophic synovium) and Disease Damage (Cartilage or Bone) scores for elbows, knees and ankles
48 months
Global Gait Score, and/or joint score items for elbows, knees and ankles.
48 months
Joint and physical evaluation for elbows, knees and ankles.
48 months
Other Outcomes (28)
Effectiveness of Elocta: Annualised bleeding rate (ABR) for treated bleeds
48 months
Effectiveness of Elocta: Annualised bleeding rate (ABR) for all bleeds
48 months
Effectiveness of Elocta: Occurrence of zero (0) joint bleeds
48 months
- +25 more other outcomes
Study Arms (1)
Hemophilia A patients
All patients diagnosed with haemophilia A regardless of severity, on factor treatment with Elocta according to usual clinical practice.
Interventions
Extended half-life factor VIII product
Eligibility Criteria
Patients diagnosed with haemophilia A regardless of severity, of any gender and age, on factor treatment with Elocta according to usual clinical practice.
You may qualify if:
- Provided signed and dated informed consent by the patient, or the patient's legally authorized representative(s) for patients under the legal age, before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations
- Have a diagnosis of haemophilia A
- At enrolment on prophylactic treatment with Elocta, independent of participation in the study
You may not qualify if:
- Presence of factor VIII antibodies (inhibitors) (≥0.60 Bethesda Unit \[BU\]/mL) at the latest available inhibitor test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
University Hospital Brno
Brno, Czechia
University Hospital Ostrava
Ostrava, Czechia
Dept. of Pediatric Haematology and Oncology, University Hospital Motol
Prague, Czechia
Lastehaigla, Tallinn (Tallinn Children´s Hospital)
Tallinn, Estonia
The North Estonia Medical Centre Hematoloogiakeskus, Regionalhaigla
Tallinn, Estonia
Helsinki University Central Hospital, New Children Hospital
Helsinki, Finland
Turku University Central Hospital, Paediatric and adolescent haematology and oncology clinic
Turku, Finland
Charité-Universitätsmedizin Berlin Campus Virchow Klinikum
Berlin, Germany
Universitätsklinikum Bonn AöR, Institut für Experimentelle Hämatologie und Transfusionsmedizin
Bonn, Germany
Hämostaseologie/Hämophiliezentrum, Medizinische Klinik 2 Institut für Transfusionsmedizin, Universitätsklinikum
Frankfurt, Germany
Universitätsklinikum Frankfurt - Klinik für Kinder- und Jugendmedizin
Frankfurt, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Werlhof-Institut für Hämostaseologie GmbH
Hanover, Germany
SRH-Klinikum Heidelberg
Heidelberg, Germany
HZRM Hämöphilie Zentrum Rhein Main
Mörfelden-Walldorf, Germany
Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital am Universitätsklinikum München
München, Germany
Ippokrateio Hospital Thessaloniki (adult department)
Thessaloniki, Greece
Ippokrateio Hospital Thessaloniki (pediatric department)
Thessaloniki, Greece
University of Bari Aldo Moro (Centro Emofilia Policlinico - Pediatria U.O.)
Bari, Italy
AUSL Romagna Centro Emofilia U.O.C., Medicina Trasfusionale Dipartimento Patologia, Clinica Ospedale M. Bufalini
Cesena, Italy
Giannina Gaslini Institute
Genova, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
University Hospital of Parma, AOUP, Haemophilia Center
Parma, Italy
Uo Malattie Emorragiche e Trombotiche Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Universitá Catolica del Sacro Coure
Rome, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino Regina Margherita
Torino, Italy
University Medical Center Groningen/UMCG
Groningen, Netherlands
The Royal Hospital
Muscat, Oman
Dr Suliman Al Habib Hospital Riyadh
Riyadh, Saudi Arabia
King Faisal Specialised Hospital, KFSH Riyadh, Children
Riyadh, Saudi Arabia
King Faisal Specialist Hospital KFSH, Adults
Riyadh, Saudi Arabia
Riyadh Military Hospital (P.S.M.C)
Riyadh, Saudi Arabia
University Medical Centre Ljubljana Division of Paediatrics
Ljubljana, Slovenia
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Sant Johan De Deu
Barcelona, Spain
Hospital Universitario Cruces
Cruces, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Hospital Universitario Carlos Haya
Málaga, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Complejo Hospitalario de Navarra
Navarro, Spain
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Alvaro Cunqueiro
Vigo, Spain
Hematologimottagning Sahlgrenska
Gothenburg, Sweden
Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital Malmö
Malmo, Sweden
Universitätsklinik für Hämatologie und Hämatologisches Zentrallabor Inselspital
Bern, Switzerland
Service et Laboratoire central d'hématologie, Adults
Lausanne, Switzerland
Zentrum für Labormedizin
Sankt Gallen, Switzerland
Universitätsspital Zürich Klinik für Medizinische Onkologie und Hämatologie
Zurich, Switzerland
East Kent Hospitals University NHS Foundation Trust, Kent Haemophilia and Thrombosis Centre, Kent and Canterbury Hospital
Canterbury, United Kingdom
Great Ormond Street Hospital, Royal London Hospital for Integrated Medicine
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Physician
Swedish Orphan Biovitrum AB
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2020
First Posted
March 3, 2020
Study Start
March 30, 2020
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share