Synovial Proliferation on Routine Ultrasound: Active or Inactive? (2BEGIN)

Van Creveldkliniek

Status: Not yet enrolling

Conditions: Hemophilia B; Haemophilia; Hemophilia a

Treatments: Other: Ultrasound imaging

Study type: Observational

Funder types: Other

Identifiers

NCT06809972

2BEGIN

Details and patient eligibility

About

There is cumulating evidence for the presence of non-observed or subclinical joint bleeding in patients with haemophilia. Early detection of active subclinical synovial proliferation would allow early intervention in order to prevent deterioration of joint health. Patients with subclinical (=non-observed) signs of synovial proliferation in knee(s), ankle(s) and/or elbow(s) will be invited to participate in this study to further characterize the synovial proliferation status (active or inactive) by means of physical examination, MRI, ultrasound and elastography. Synovial proliferation status will be monitored for a maximum period of 12 weeks, during which participants will also receive standard-of-care treatment, i.e. administration of optimized coagulation factor replacement therapy and prescription of the NSAID celecoxib (optional).

Full description

To be completed

Enrollment: 46 estimated patients

Sex: Male

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.