Severity Over Time of Early Forms of Spondyloarthritis (STAR)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Spondyloarthritis; Spondyloarthritis, Axial
• Intervention / Treatment: Diagnostic test: Diagnostic assessment; Diagnostic test: Diagnostic assessment

• Study Type: Observational
• Enrollment (Estimated): 387

Contacts and Locations

• Study Contact: Name: Maria Antonietta D'Agostino, Professor; Phone Number: +390630157807; Email: mariaantonietta.dagostino@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Principal Investigator: Maria Antonietta D'Agostino
    • Contact: Maria Antonietta D'Agostino; Phone Number: +390630155701; Email: mariaantonietta.dagostino@policlinicogemelli.it
    • Sub-Investigator: Augusta Ortolan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): February 12, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2044

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Axial Spondyloarthritis
• Other Study ID Numbers: 6313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No