Monitoring Disease Activity in Patients With Takayasu Arteritis With the OMERACT Takayasu Ultrasound Score (OTUS) (MOTUS)
2026. május 6. frissítette: 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.
A tanulmány áttekintése
Állapot
Még nincs toborzás
Körülmények
Részletes leírás
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.
Tanulmány típusa
Megfigyelő
Beiratkozás (Becsült)
100
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Mintavételi módszer
Nem valószínűségi minta
Tanulmányi populáció
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.
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in OTUS between active disease and remission in patients with Takayasu arteritis
Időkeret: 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.
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
To evaluate the agreement between OTUS-based activity assessment and NIH disease activity score
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Reference values for arterial wall thickness measured by vascular ultrasound in assessed arterial segments
Időkeret: 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
Időkeret: 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
Időkeret: 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.
Időkeret: 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.
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
2026. július 1.
Elsődleges befejezés (Becsült)
2032. december 31.
A tanulmány befejezése (Becsült)
2032. december 31.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. április 23.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. április 30.
Első közzététel (Tényleges)
2026. május 6.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. május 11.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 6.
Utolsó ellenőrzés
2026. május 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- TAK-MOTUS
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
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