Takayasu Arteritis (TAK)MOTUSNCT07571577
Monitoring Disease Activity in Patients With Takayasu Arteritis With the OMERACT Takayasu Ultrasound Score (OTUS)
An observational study of Takayasu Arteritis (TAK), run by IRCCS San Raffaele.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takayasu Arteritis (TAK)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients with TAK and active disease, either newly diagnosed or experiencing a relapse. Active disease is defined as the presence of clinical signs and/or symptoms attributable to TAK, with or without elevation of inflammatory markers (ESR, CRP), and/or imaging evidence of active vasculitis (excluding US findings used in OTUS scoring). Patients of any gender, aged ≥18 years, will be eligible.
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
About this study
Official title: A Multicenter Prospective Observational Study on the Role of the OMERACT Takayasu Ultrasound Score (OTUS) in Monitoring Disease Activity in Patients With Takayasu Arteritis
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.
Read the detailed description
This is an observational study. The study concerns a diagnostic procedure (vascular US) that is part of normal clinical practice for patients with large-vessel vasculitis (LVV). The decision to perform vascular US in patients with TAK will remain independent from the decision to enroll the patient in the study. No investigational medicinal product or experimental device is involved. The procedure under study is an ultrasonographic scoring system derived from vascular US examinations of selected arterial segments in patients with TAK. Examinations will be performed according to standardized OMERACT protocols, including assessment of the common carotid, subclavian and axillary arteries, and the abdominal aorta. For each patient, an OMERACT-derived OTUS score will be calculated at each assessment. No comparator is mandated; however, clinical disease activity state and results from other imaging modalities (FDG-PET, MRA, CTA), when available as part of routine clinical care, will be collected for exploratory analyses. Study participation will last 24 months, during which patients will undergo serial US examinations at predefined follow-up visits as part of routine clinical monitoring. Vascular US is a non-invasive, radiation-free and contrast-free technique, already employed in standard clinical care and used here exclusively for observational purposes.
- Conditions
- Takayasu Arteritis (TAK)
- Medical subject headings
- Takayasu Arteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OTUS between active disease and remission in patients with Takayasu arteritis
Change in OTUS from baseline (active disease) to the first visit at which clinical remission is achieved, as determined by the treating physician (blinded to ultrasound results).
Measured: 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.
Secondary outcomes (12)
Correlation between OTUS changes and clinical/laboratory markers of disease activity in Takayasu arteritis
Correlation between OTUS variation and: (i) ESR/CRP; (ii) clinical disease activity, as assessed by the Physician Global Assessment (PGA) of disease activity (0-10 visual analogue scale) and the National Institutes of Health (NIH) disease activity score for Takayasu arteritis.
Measured: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
Agreement between OTUS-based disease activity classification and Physician Global Assessment (PGA) in Takayasu arteritis
Cohen's kappa coefficient measuring agreement between OTUS-based disease activity classification and Physician Global Assessment (PGA) of disease activity, assessed on a 0-10 visual analogue scale.
Measured: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
To evaluate the agreement between OTUS-based activity assessment and NIH disease activity score
Cohen's kappa coefficient measuring agreement between OTUS-based disease activity classification and the National Institutes of Health (NIH) disease activity score for Takayasu arteritis (range 0-4, with higher scores indicating more active disease).
Measured: Baseline, month 1, month 3, month 6, month 12, month 18, month 24
Hazard ratio for time to relapse per unit increase in baseline OTUS score
Time to disease relapse (months), defined as recurrence of clinical signs and/or symptoms attributable to TAK with or without elevation of inflammatory markers, as judged by the treating physician. The hazard ratio per unit increase in baseline OTUS score will be estimated using Cox proportional-hazards regression.
Measured: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
Hazard ratio for time to vascular damage progression per unit increase in baseline OTUS score
Time to vascular damage progression (months), defined as new or worsening stenosis, occlusion, or aneurysm detected on CTA, MRA, or vascular US compared to baseline. The hazard ratio per unit increase in baseline OTUS score will be estimated using Cox proportional-hazards regression.
Measured: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
Odds ratio for successful glucocorticoid discontinuation per unit increase in baseline OTUS score
Proportion of patients achieving successful glucocorticoid discontinuation, defined as complete GC tapering without relapse for at least 3 consecutive months. The odds ratio per unit increase in baseline OTUS score will be estimated using logistic regression.
Measured: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
Hazard ratio for time to relapse per unit increase in OTUS change from baseline to month 3
Time to disease relapse (months), defined as recurrence of clinical signs and/or symptoms attributable to TAK with or without elevation of inflammatory markers, as judged by the treating physician. The hazard ratio per unit increase in OTUS change from baseline to month 3 (ΔOTUS) will be estimated using Cox proportional-hazards regression.
Measured: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
Hazard ratio for time to vascular damage progression per unit increase in OTUS change from baseline to month 3
Time to vascular damage progression (months), defined as new or worsening stenosis, occlusion, or aneurysm detected on CTA, MRA, or vascular US compared to baseline. The hazard ratio per unit increase in OTUS change from baseline to month 3 (ΔOTUS) will be estimated using Cox proportional-hazards regression.
Measured: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
Odds ratio for successful glucocorticoid discontinuation per unit increase in OTUS change from baseline to month 3
Proportion of patients achieving successful glucocorticoid discontinuation, defined as complete GC tapering without relapse for at least 3 consecutive months. The odds ratio per unit increase in OTUS change from baseline to month 3 (ΔOTUS) will be estimated using logistic regression.
Measured: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
To assess the diagnostic ability of OTUS to detect clinical relapse during follow-up.
Diagnostic performance of OTUS for relapse detection
Measured: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
Absolute OTUS score in treatment responders vs non-responders
Absolute OTUS score at each visit compared between clinical responders and non-responders to treatment, defined by physician global assessment. Difference between groups will be assessed using Mann-Whitney U test, with effect size estimation.
Measured: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
OTUS change from baseline (ΔOTUS) in treatment responders vs non-responders
Change in OTUS score from baseline to each follow-up visit (ΔOTUS) compared between clinical responders and non-responders to treatment, defined by physician global assessment. Difference between groups will be assessed using Mann-Whitney U test, with effect size estimation.
Measured: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takayasu Arteritis (TAK)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, University Hospital Padova
- Responsible party
- Principal investigator, Tomelleri Alessandro, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571577
- Sponsor's protocol ID
- TAK-MOTUS
- Acronym
- MOTUS
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No