Synovial Proliferation on Routine Ultrasound: Active or Inactive?

Launched by VAN CREVELDKLINIEK · Jan 30, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a condition called subclinical synovial proliferation in patients with haemophilia, which means that some patients may have hidden inflammation in their joints that isn't visibly bleeding but could lead to joint problems over time. The goal of the study is to better understand whether this inflammation is active or inactive. By identifying it early, healthcare providers can intervene sooner to help protect joint health. The trial will involve physical exams, MRI, ultrasound, and elastography (a type of imaging that looks at tissue stiffness) over a period of up to 12 weeks. Participants will also receive standard treatment for their haemophilia, which includes medication to help manage bleeding.

To be eligible for this study, participants must be male patients aged 12 or older with severe haemophilia A or B, and they must show signs of subclinical synovial proliferation in at least one joint (like the knee, ankle, or elbow) as confirmed by routine ultrasound. Those with recent bleeding events, certain joint conditions, or specific health issues that prevent them from taking standard medications will not be included. As the trial is not yet recruiting, interested patients will need to wait for more information on how to participate. Overall, this study hopes to enhance the understanding of joint health in people with haemophilia and improve future treatments.

Gender

MALE

Eligibility criteria

• 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.