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Clinical Trials/NCT06261931
NCT06261931Not yet recruitingNot Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country387 target enrollmentStarted: February 12, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
387
Locations
1
Primary Endpoint
spondyloarthritis severity

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • age >18 years;
  • Diagnosis of SpA confirmed by the rheumatologist with duration of symptoms <
  • 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.

Outcomes

Primary Outcomes

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

evaluation of disease severity at 10 years in the entire study population

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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