Synovial Proliferation on Routine Ultrasound: Active or Inactive?
Study Details
- Hemophilia
- Hemophilia A
- Hemophilia B
- Inclusion Criteria:
- Gender: male
- Patients with severe haemophilia A or B
- Treated with registered prophylaxis medication including coagulation factors and by- passing agents.
- Age ≥ 12 years
- Subclinical synovial proliferation in ≥1 joint (ankle, knee and/or elbow), defined as the presence of hypertrophic synovium, score \>0 according to the HEAD-US protocol, as confirmed during routine ultrasound screening.
- Able to give written informed consent.
- Exclusion Criteria:
- A major bleed ≤ 3 months or a minor bleed ≤ 1 month prior to inclusion in the joint of interest.
- On demand therapy.
- Currently treated with any type of haemophilia prophylaxis medication.
- Joints with prosthesis or treated with arthrodesis will not be included for physical examination and ultrasound analysis. However, participants may still be included in the study with their other joints.
- Confirmed inflammatory joint diseases such as rheumatoid arthritis or psoriatic arthritis.
- History of inhibitor development (≥ 5 Bethesda Units\* (BU) at any time or 1-5 BU for
- 1 year prior to inclusion.
- Contra-indication for treatment with NSAIDs, (allergy, severe liver failure, renal failure (GFR \<30ml/min), congestive heart failure (NYHA II-IV), peripheral arterial disease and/or cerebrovascular disease.
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.