Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy
Study Details
- Hemophilia
- Hemophilia A
- Hemophilia B
- Age 18 years or older.
- Diagnosis of haemophilia A or B.
- Haemophilic arthropathy previously diagnosed and documented by the participant's haemophilia treatment centre.
- Persistent or recurrent pain for at least 3 months in one or more affected joints.
- Sufficient capacity to understand the programme content, follow study instructions and complete the assessment instruments.
- Ability to provide written informed consent.
- Sufficient understanding of Spanish to complete the study procedures and questionnaires.
- Neurological or cognitive impairment that interferes with understanding of the intervention or completion of assessments.
- Musculoskeletal surgery within the 2 months preceding inclusion.
- Acute bleeding episode or acute musculoskeletal event within the 4 weeks preceding baseline assessment that would preclude valid completion of the assessment.
- Concurrent participation in another structured educational or psychological intervention programme specifically targeting pain.
- Insufficient understanding of Spanish to complete the study questionnaires.
Protocol Summary
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.