SpondyloarthritisSTARNCT06261931
Severity Over Time of Early Forms of Spondyloarthritis
An observational study of Spondyloarthritis and Spondyloarthritis, Axial, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis, Spondyloarthritis, Axial
- What is being tested?
- Diagnostic assessment
- How many people
- 387 participants
- Where
- 1 siteItaly
- Study dates
- 12 Feb 2024to 28 Feb 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with recent onset of SpA (duration of symptoms ≤2 years) and diagnosis made by the rheumatologist.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Antonietta D'Agostino, Professor contact
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Maria Antonietta D'Agostino, +390630155701, mariaantonietta.dagostino@policlinicogemelli.it
Maria Antonietta D'Agostino
About this study
Official title: 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.
- Conditions
- Spondyloarthritis, Spondyloarthritis, Axial
- Being tested
- Diagnostic assessment
- Medical subject headings
- Spondylarthritis, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic assessmentDiagnostic 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.
Diagnostic assessmentDiagnostic test
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
What is being measured
The primary outcome is the main question the study is designed to answer.
spondyloarthritis severity
evaluation of disease severity at 10 years in the entire study population
Measured: t0 baseline 3hours, t1 3 months 3hours,t2 6 months 3hours,t2 12months 3hours,every six months up to the tenth year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start12 Feb 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261931
- Sponsor's protocol ID
- 6313
- Acronym
- STAR
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severity Over Time of Early Forms of Spondyloarthritis, a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06261931
- Acronym / sponsor ID
- STAR / 6313
- Conditions
- Spondyloarthritis, Spondyloarthritis, Axial
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 12 Feb 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2044 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with recent onset of SpA (duration of symptoms ≤2 years) and diagnosis made by the rheumatologist.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic assessmentpatient 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 test | – |
| Diagnostic assessmentperipheral 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 | Diagnostic test | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Antonietta D'Agostino, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthritis and Spondyloarthritis, Axial, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Antonietta D'Agostino, Professor (+390630157807, mariaantonietta.dagostino@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.