Monitoring Disease Activity in Patients With Takayasu Arteritis With the OMERACT Takayasu Ultrasound Score (OTUS) (MOTUS)
6 de mayo de 2026 actualizado por: Tomelleri Alessandro, IRCCS San Raffaele
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
100
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in OTUS between active disease and remission in patients with Takayasu arteritis
Periodo de tiempo: 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.
|
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).
|
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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To evaluate the agreement between OTUS-based activity assessment and NIH disease activity score
Periodo de tiempo: Baseline, month 1, month 3, month 6, month 12, month 18, month 24
|
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).
|
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
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
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.
|
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
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
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.
|
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
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
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.
|
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
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
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.
|
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
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
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.
|
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
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
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.
|
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.
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
Diagnostic performance of OTUS for relapse detection
|
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
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
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.
|
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
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
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.
|
US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
|
Correlation between OTUS changes and clinical/laboratory markers of disease activity in Takayasu arteritis
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
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.
|
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
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
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.
|
US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reference values for arterial wall thickness measured by vascular ultrasound in assessed arterial segments
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
Arterial wall thickness (mm) measured by standardized vascular ultrasound in the bilateral common carotid, subclavian and axillary arteries, and abdominal aorta.
Descriptive statistics will be used to define reference values and proposed normality cut-offs.
|
US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
|
Change in OTUS score over time stratified by treatment class
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
Change in OTUS score (continuous, expressed as ΔOTUS from baseline) over 24 months, compared across therapeutic classes (e.g., glucocorticoids alone, conventional immunosuppressants, biologics).
Differences between treatment groups will be analyzed using linear mixed-effects models.
|
US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
|
Proportion of patients with changes in ultrasound lesion characteristics over time stratified by treatment class
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
Proportion of patients (%) showing new, resolved, or persistent elementary ultrasound lesions (macaroni sign, stenosis, occlusion) as defined by OMERACT criteria, compared across therapeutic classes.
Differences between treatment groups will be described using proportions and compared using chi-square or Fisher's exact test as appropriate.
|
US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
|
To compare OTUS findings with FDG-PET, MRA and/or CTA obtained as part of routine clinical practice.
Periodo de tiempo: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
Concordance between OTUS and PET/MRA/CTA findings, both qualitative and quantitative (when available).
|
US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2032
Finalización del estudio (Estimado)
31 de diciembre de 2032
Fechas de registro del estudio
Enviado por primera vez
23 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TAK-MOTUS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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