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VasculitisSMARTNCT07586137

SysteMic vAsculitis pRognosis and ouTcome

An observational study of Vasculitis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This will be a pragmatic programme of research, consecutively recruiting all-comers who have been referred to secondary care for assessment of suspected Systemic Vasculitis (SV) into a longitudinal inception cohort. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vasculitis
How many people
300 participants
Where
1 siteItaly
Study dates
8 Feb 2022to 15 Jun 2030
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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: patients with a diagnosis of vasculitis

Who may be able to join

  • Willing and able to give informed consent
  • clinical suspicion or a confirmed diagnosis of Systemic Vasculitis

Who cannot join

  • Inability to give informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carlomaurizio Montecucco, MD contact

+390382502948

c.montecucco@smatteo.pv.it

Italy1 site, 1 recruiting
  • Fondazione IRCCS Policlinico San Matteo, SC Reumatologia

    Pavia, Pavia, 27100

    Carlomaurizio Montecucco, MD, +390382502948, c.montecucco@smatteo.pv.it

    Recruiting

Other trials in Italy

About this study

This will be a pragmatic programme of research, consecutively recruiting all-comers who have been referred to secondary care for assessment of suspected Systemic Vasculitis (SV) into a longitudinal inception cohort. For patients with a pre-existing diagnosis, data on the disease onset will be collected retrospectively. All patients followed prospectively from the time of inclusion into the study will be followed at intervals corresponding to the recommended standard of care. We will invite participants to consent to the whole programme of research in order to allow their samples, as well as their data, to be used for in multiple related projects that have the same common aim. In this long-term inception cohort we will collect data on clinical features, prognostic factors and outcomes of patients diagnosed with a SV over the course of 10 years. We will examine the role of clinical features, imaging and biomarkers in the characterisation of the disease with a particular focus on risk stratification. This will be closely integrated with the other objectives of the study: analysing clinical features, imaging characteristics, outcomes, rates and predictors of relapses and remission, in order to obtain a prognostic stratification of the patients and to capture a cohort of patients at high risk of relapse and poor outcome who could inform on the potential use of more intensive treatment strategies to be assessed in future studies.

The SMART programme will be guided by three main overarching themes:

Read more
  1. "Theme 1": The identification of risk factors associated with poor outcome, relapse and failure to achieve remission
  2. "Theme 2": The assessment of different tools to assess risk factors (imaging, biomarkers, clinical features)
  3. "Theme 3": The analysis of cohorts of SV patients in observational studies The overarching aims of the study will be overlapping throughout the different investigations outlined in the following paragraphs analyzing: outcomes (including treatment-derived damage), monitoring and relapse, and remission in SV.

We aim to follow patients up over a total of 10 years, in order to provide the richest and most complete set of data that has ever been collected for this patient group.

Conditions
Vasculitis
Medical subject headings
Vasculitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality

    Measured: 10 years

  2. vasculitis complications

    Measured: 10 years

  3. rate of relapse

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start8 Feb 2022
  3. Primary completion15 Jun 2028 (estimated)
  4. Study completion15 Jun 2030 (estimated)

Resources

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
300 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07586137
Sponsor's protocol ID
SMART
Acronym
SMART
Status last verified
May 2026
First submitted
8 May 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Vasculitis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carlomaurizio Montecucco, MD (+390382502948, c.montecucco@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mortality (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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