Severity Over Time of Early Forms of Spondyloarthritis

Spondyloarthritis Clinical Trial

— STAR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06261931
• Other study ID #: 6313
• Status: Not yet recruiting
• Start date: February 12, 2024
• Est. completion date: February 28, 2044

Study information

• Verified date: February 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Maria Antonietta D'Agostino, Professor
• Phone: +390630157807
• Email: mariaantonietta.dagostino[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 387
• Est. completion date: February 28, 2044
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis
• Spondyloarthritis, Axial

Intervention

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 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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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