MOTIVATE study design
MOTIVATE
MOdern Treatment of Inhibitor-PositiVe PATiEnts with Haemophilia A
MOTIVATE is a multicentre, investigator-initiated study registered as a non-interventional study in the US (NCT04023019) and a low-interventional, pragmatic trial in Europe (EudraCT No. 2019-003427-38). The study was initiated by two investigators: Dr Carmen Escuriola-Ettingshausen and Dr Robert Sidonio Jr.
MOTIVATE aims to compare the efficacy and safety of different treatment approaches for patients with haemophilia A and inhibitors.
Who we areOverall objectives
- To capture different approaches to the treatment and management of people with haemophilia A and inhibitors
- To document current ITI approaches from real-world clinical experience
- To compare safety and efficacy of ITI, emicizumab prophylaxis, and ITI with emicizumab prophylaxis
Study design and endpoints
MOTIVATE will include patients who are treated with FVIII ITI, emicizumab, or FVIII ITI with emicizumab prophylaxis. For patients on ITI, results will be compared in those treated with ITI alone and those treated with both ITI and emicizumab.
The rate of bleeding will be compared across all three groups.
A number of other measures will also be compared, including the severity of bleeds, treatment safety and treatment costs.
Study design and primary endpoints
MOTIVATE plans to follow 120 patients for up to five years. All treatment decisions, including dosing, will be made by the investigator.
Any patient with haemophilia A who has developed inhibitors to a FVIII product can take part in the study. Patients who are already being treated with one of the treatment approaches may be able to join if the required information on their medical history is available.
Patients can also participate in any number of the optional sub-studies. The MOTIVATE sub-studies are exploring factors that may influence ITI results as well as the impact of different treatment approaches on a number of important aspects of patient health.
Current statusPatient eDiary
A MOTIVATE eDiary enables fast and simple data collection
Patients will enter information in the eDiary which will be visible to their treating physician.
The eDiary allows patients to enter information on
- Treatment
- Bleeding episodes
- Adverse drug reactions
- Concomitant medications
- Non-drug therapies
The eDiary has been developed in collaboration with umotif.