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Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination (A-MOVE)

Primary Purpose

Hemophilia A

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound, Haemophilia Joint Health Score
Sponsored by
Swedish Orphan Biovitrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hemophilia A focused on measuring joint health

Eligibility Criteria

6 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 6-40 years
  • Haemophilia A patients treated with plasma-derived factor VIII (pdFVIII) or recombinant (conventional or extended half-life) factor VIII (rFVIII)
  • At least one joint bleeding episode prior to inclusion
  • Signed informed consent

Exclusion Criteria:

  • Enrolment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product, within three months prior to inclusion in the study
  • Presence of factor VIII antibodies (inhibitors) (≥0.60 Bethesda Unit [BU]/mL) at the latest available inhibitor test
  • Joint surgery over the past year prior to inclusion in one of the following joints; left knee, right knee, left elbow, right elbow, left ankle and right ankle
  • More than one joint replacement

Sites / Locations

  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Reserach site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research site
  • Swedish Orphan Biovitrum Research Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Haemophilia A patients

Arm Description

Treated on-demand or prophylaxis with any Factor VIII (FVIII) product, plasma derived or recombinant (conventional or extended-half life) FVIII, according to routine clinical practice.

Outcomes

Primary Outcome Measures

Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US
Yes/No

Secondary Outcome Measures

Full Information

First Posted
October 18, 2019
Last Updated
August 17, 2023
Sponsor
Swedish Orphan Biovitrum
Collaborators
Cerner Enviza
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1. Study Identification

Unique Protocol Identification Number
NCT04133883
Brief Title
Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination
Acronym
A-MOVE
Official Title
A Study to Investigate if the Use of a Systematic Joint Examination (Ultrasound/Functional/Physical) Has an Impact on the Physician's Haemophilia Treatment Management Decision in Patients With Haemophilia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
July 13, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Orphan Biovitrum
Collaborators
Cerner Enviza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This low interventional study aims to describe if and how the haemophilia treatment management decisions are impacted by a systematic joint examination (ultrasound, functional, physical) in patients with haemophilia A in France.
Detailed Description
The study will assess the behavior of the physicians with regards to haemophilia management decisions, and if systematic joint examination have an impact on their decisions. The main objective is to evaluate if the use of HEAD-US and Haemophilia Joint Health Score (HJHS) have an impact on these decisions. The study is classified as a low-interventional study due to mandated systematically assessment (HEAD-US, HJHS) on patients which may not be part of routine clinical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
Keywords
joint health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Haemophilia A patients
Arm Type
Other
Arm Description
Treated on-demand or prophylaxis with any Factor VIII (FVIII) product, plasma derived or recombinant (conventional or extended-half life) FVIII, according to routine clinical practice.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound, Haemophilia Joint Health Score
Intervention Description
Systematic joint examinations of ankles, knees and elbows
Primary Outcome Measure Information:
Title
Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US
Description
Yes/No
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 6-40 years Haemophilia A patients treated with plasma-derived factor VIII (pdFVIII) or recombinant (conventional or extended half-life) factor VIII (rFVIII) At least one joint bleeding episode prior to inclusion Signed informed consent Exclusion Criteria: Enrolment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product, within three months prior to inclusion in the study Presence of factor VIII antibodies (inhibitors) (≥0.60 Bethesda Unit [BU]/mL) at the latest available inhibitor test Joint surgery over the past year prior to inclusion in one of the following joints; left knee, right knee, left elbow, right elbow, left ankle and right ankle More than one joint replacement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Santagostino
Organizational Affiliation
Swedish Orphan Biovitrum
Official's Role
Study Director
Facility Information:
Facility Name
Swedish Orphan Biovitrum Research site
City
Angers
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Bordeaux
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Brest
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Caen
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Chambéry
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Clermont-Ferrand
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Dijon
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Le Kremlin-Bicêtre
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Lyon
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Marseille
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Montpellier
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Nancy
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Nantes
Country
France
Facility Name
Swedish Orphan Biovitrum Reserach site
City
Paris
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Poitiers
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Reims
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Rouen
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Strasbourg
Country
France
Facility Name
Swedish Orphan Biovitrum Research site
City
Toulouse
Country
France
Facility Name
Swedish Orphan Biovitrum Research Site
City
Tours
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination

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