Is synovial proliferation in haemophilia joints active or inactive?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows males aged 12 and older with severe haemophilia A or B who have subclinical synovial proliferation in at least one knee, ankle, or elbow identified on routine ultrasound. Participants receive physical examination and advanced imaging (ultrasound, MRI, and elastography) and are monitored for up to 12 weeks while continuing standard-of-care coagulation factor replacement and optional celecoxib. The study aims to classify synovial proliferation as active or inactive using clinical findings and imaging signatures. No experimental drug is given; the focus is on characterizing imaging markers that may indicate ongoing subclinical joint bleeding.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Medical Center Utrecht
  Utrecht, Netherlands Recruiting

Study contacts

• Principal investigator: Lize van Vulpen, MD, PhD — University Medical Center Utrecht - Van Creveldkliniek
• Study coordinator: Lize van Vulpen, MD, PhD
• Email: l.f.d.vanvulpen-2@umcutrecht.nl
• Phone: +31887558450

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.