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

NCT07571577 | Not Yet Recruiting

• 1 other identifier: TAK-MOTUS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Takayasu Arteritis (TAK)

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in OTUS from baseline (active disease) to the first visit in which remission is achieved according to the treating physician (blinded to US 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.

Secondary Outcomes (12)

• To assess the correlation between OTUS changes and clinical/laboratory markers of disease activity.

  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 Physician Global Assessment (PGA)

  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

  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

  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

  US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.

Other Outcomes (4)

• Reference values for arterial wall thickness measured by vascular ultrasound in assessed arterial segments

  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

  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

  US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Azienda USL Reggio Emilia - IRCCS: collaborator
• University Hospital Padova: collaborator

MeSH Terms

Conditions

Takayasu Arteritis

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share