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RecruitingNCT07586137SMARTUpdated May 14, 2026

SysteMic vAsculitis pRognosis and ouTcome

An observational study in Vasculitis, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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. 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:

  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.

02

Conditions studied

  • Vasculitis

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03

In context

Vasculitis

170 studies on the registry are indexed under Vasculitis; 46 are open to participants now.

This study's planned enrollment of 300 is above the median of 147 across 77 observational studies indexed under Vasculitis.

Browse Vasculitis studies →

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with a diagnosis of vasculitis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Inability to give
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. mortality

    Time frame: 10 years

  2. vasculitis complications

    Time frame: 10 years

  3. rate of relapse

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07586137
Responsible party
Alessandra Milanesi (Principal Investigator, Fondazione IRCCS Policlinico San Matteo di Pavia) — Principal investigator
First posted
May 14, 2026
Start date
Feb 8, 2022
Primary completion
Jun 15, 2028 (estimated)
Completion
Jun 15, 2030 (estimated)
Last update
May 14, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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