Severity Over Time of Early Forms of Spondyloarthritis

NCT06261931 | Not Yet Recruiting

• 1 other identifier: 6313
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthritis; Spondyloarthritis, Axial

Outcome Measures

Primary Outcomes (1)

• spondyloarthritis severity

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

  t0 baseline 3hours, t1 3 months 3hours,t2 6 months 3hours,t2 12months 3hours,every six months up to the tenth year

Interventions

Diagnostic assessment DIAGNOSTIC_TEST

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.

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

patients with recent onset of SpA (duration of symptoms ≤2 years) and diagnosis made by the rheumatologist.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Spondylarthritis; Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spondylarthropathies; Ankylosis

Central Study Contacts

Maria Antonietta D'Agostino, Professor

CONTACT

+390630157807; mariaantonietta.dagostino@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 15, 2024
• Study Start: February 12, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2044
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

IT (1)