Not Yet RecruitingNot Applicable

Monitoring Disease Activity in Patients With Takayasu Arteritis With the OMERACT Takayasu Ultrasound Score (OTUS)

100 participantsStarted 2026-07-01

Plain-language summary

This is a multicenter prospective observational study aimed at evaluating the role of an ultrasonographic score in monitoring disease activity in patients with Takayasu arteritis (TAK). Patients with active disease, either at new diagnosis or during relapse, will undergo serial vascular US assessments during follow-up according to routine clinical practice at each participating centers. For each patient, an OMERACT-derived US score (OTUS) will be calculated. This score was developed and preliminarily validated in previous phases of a multistep project endorsed by OMERACT (Outcome Measures in Rheumatology), an international initiative focused on the development and validation of outcome measures in rheumatology. The study hypothesis is that this score is sensitive to change over time and can be used to monitor disease activity and predict outcome in patients with TAK.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years * Male and female * Diagnosis of TAK according to the 1990 ACR and/or 2022 ACR/EULAR classification criteria * Active disease, defined as the presence of at least two of the following three domains: * Clinical domain: new onset or worsening of clinical signs and/or symptoms attributable to TAK; * Laboratory domain: elevation of inflammatory markers, defined as ESR and/or CRP above the upper limit of normal according to local laboratory standards, not attributable to causes other than TAK; * Imaging domain: imaging evidence of active vasculitis on modalities other than ultrasound, including FDG-PET, magnetic resonance angiography (MRA), or computed tomography angiography (CTA). * Ability to undergo serial vascular ultrasound assessments during follow-up * Provision of signed informed consent Exclusion Criteria: * Inability or contraindication to undergo vascular US * Severe comorbidities limiting participation or follow-up * Concomitant conditions that may confound ultrasound findings (e.g., significant atherosclerosis requiring intervention, complete occlusion of one of the arterial segments under investigation) * Diagnosis of another rheumatologic disease * Refusal or inability to provide informed consent

What they're measuring

To evaluate whether the OTUS score, an OMERACT-derived vascular ultrasound score, is sensitive to change between clinically active disease and remission in patients with TAK.

Timeframe: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24. For the primary endpoint only baseline → first remission visit will be analyzed.

Trial details

NCT IDNCT07571577

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2032-12-31

View on ClinicalTrials.gov More Takayasu Arteritis (TAK) trials