Severity Over Time of Early Forms of Spondyloarthritis

NCT ID: NCT06261931

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 387 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2044-02-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

Countries

Italy

Central Contacts

Maria Antonietta D'Agostino, Professor

Role: CONTACT

mariaantonietta.dagostino@policlinicogemelli.it

+390630157807

Facility Contacts

Maria Antonietta D'Agostino

Role: primary

mariaantonietta.dagostino@policlinicogemelli.it

+390630155701

Other Identifiers

6313

Identifier Type: -

Identifier Source: org_study_id