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NCT Number: NCT06261931

Severity Over Time of Early Forms of Spondyloarthritis

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.

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Key information

Conditions

Spondyloarthritis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondyloarthritis, Axial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location contact

Augusta Ortolan

SUB_INVESTIGATOR

Maria Antonietta D'Agostino

CONTACT

[email protected]

+390630155701

Maria Antonietta D'Agostino

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Antonietta D'Agostino, Professor

CONTACT

[email protected]

+390630157807

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: STAR

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2044
First posted: Feb 15, 2024
Registry last updated: Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed