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Not yet recruiting NCT06261931

Severity Over Time of Early Forms of Spondyloarthritis

Observational Spondyloarthritis Spondyloarthritis, Axial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diagnostic assessment, Diagnostic assessment.
Who it may be relevant to
Registry conditions: Spondyloarthritis, Spondyloarthritis, Axial. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Severity Over Time of Early Forms of Spondyloarthritis, a Prospective Observational Study.

Overview

Spondyloarthritis (SpA) is a group of chronic inflammatory pathologies whose progression over time is poorly defined, and in particular the clinical and instrumental elements that can predispose to a condition of disease severity are not completely known. It would be important to have an idea of what the predisposing factors are, possibly already at baseline, and possibly also at follow up, of severe disease, so as to be able to act early with more aggressive and targeted therapies on these patients, so as to achieve remission.

Interventions

  • Diagnostic test Diagnostic assessment
    patient with sponiloarthritis who comes to the clinic Hospital for clinical evaluation of disease. Assessment instrumental evaluation of the axial involvment t, with x-ray of the spine and pelvis every 5 years, and MRI of the spine and pelvis every 2 years.
  • Diagnostic test Diagnostic assessment
    peripheral involvement, with joint ultrasound at baseline, at 3 months from the start of a new therapy, and therefore in the event of reactivation of the disease

Primary outcome measures

  • spondyloarthritis severity [Time frame: t0 baseline 3hours, t1 3 months 3hours,t2 6 months 3hours,t2 12months 3hours,every six months up to the tenth year]

Eligibility criteria

Inclusion criteria

  • age \>18 years;
  • Diagnosis of SpA confirmed by the rheumatologist with duration of symptoms \<
  • 2 years;
  • Signature of the written informed consent to the study

Exclusion criteria

  • Age \< 18 years;
  • Patients suffering from other rheumatic pathologies (even in overlap), or genetic diseases such as Marfan syndrome, Ehlers Danlos syndrome
  • Any medical or psychiatric condition that in the judgment of the investigator would prevent the participant from complying with the protocol or completing the study according to the protocol.
  • Refusal to sign the informed consent to the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma

Identifiers

NCT: NCT06261931 · 6313

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗