Actively Recruiting

Age: 12Years +
MALE
NCT06809972

Synovial Proliferation on Routine Ultrasound: Active or Inactive?

Led by Van Creveldkliniek · Updated on 2026-05-05

46

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

Synovial Proliferation on Routine Ultrasound: Active or Inactive?

Who Can Participate

Age: 12Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male gender
  • Diagnosis of severe haemophilia A or B
  • Receiving registered prophylaxis medication including coagulation factors or by-passing agents
  • Age 12 years or older
  • Presence of subclinical synovial proliferation in at least one joint (ankle, knee, or elbow) confirmed by routine ultrasound using HEAD-US protocol
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Major joint bleed within 3 months or minor joint bleed within 1 month before study entry in the joint of interest
  • Receiving on-demand therapy instead of prophylaxis
  • Currently not receiving any haemophilia prophylaxis medication
  • Joints with prosthesis or treated with arthrodesis are excluded from examination and ultrasound analysis
  • Confirmed inflammatory joint diseases such as rheumatoid arthritis or psoriatic arthritis
  • History of inhibitor development (≥5 Bethesda Units at any time or 1-5 BU for 1 year before inclusion)
  • Contraindications for NSAIDs, including allergy, severe liver failure, renal failure (GFR <30 ml/min), congestive heart failure (NYHA II-IV), peripheral arterial disease, or cerebrovascular disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Medical Center Utrecht

Utrecht, Netherlands, 3584CX

Actively Recruiting

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Research Team

L

Lize van Vulpen, MD, PhD

CONTACT

M

Merel Timmer, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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