A Study in Participants With a Newly Confirmed Diagnosis of Spondyloarthritis (SpA) Who Are New t… (NCT03131661) | Clinical Trial Compass
CompletedNot Applicable
A Study in Participants With a Newly Confirmed Diagnosis of Spondyloarthritis (SpA) Who Are New to Conventional, Targeted and Biological DMARDs
Italy351 participantsStarted 2017-06-09
Plain-language summary
The purpose of this Italian multicenter study is to collect prospective clinical data in participants with first diagnosis or confirmation diagnosis of Spondyloarthritis (SpA), according to Assessment of Spondyloarthritis classification (ASAS) criteria, in order to describe SpA characteristics and pattern of clinical presentation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have a first or confirmed diagnosis of Spondyloarthritis (SpA) according to Assessment of Spondyloarthritis classification (ASAS) criteria
* Participants must be naïve to conventional, targeted and biological Disease modifying anti-rheumatic drugs (DMARDs) treatment
* Participants must understand the purpose of the study
* Participants must sign a participation agreement/ Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
Exclusion Criteria:
* Participants who already started conventional, targeted and biological DMARDs treatment for SpA
* Participants who participate to an investigational study in the last 30 days
* Participants unwilling or unable to participate in long-term, 24 months, data collection
* Participants unwilling or unable to fill in the Participant-reported outcome (PRO) foreseen by the protocol
* Participants unwilling or unable to sign the informed consent to the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Delay
Timeframe: Baseline (Month 0)
2
Prevalence of Axial Versus Peripheral Manifestations According to Assessment of Spondyloarthritis Classification (ASAS) Criteria
Timeframe: Up to visit 5 (Approximately 24 months)
3
Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by ASDAS Score
Timeframe: Up to visit 5 (Approximately 24 months)
4
Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by BASMI Score
Timeframe: Up to visit 5 (Approximately 24 months)
5
Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by DAS28 Score
Timeframe: Up to visit 5 (Approximately 24 month)
6
Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by Disease Activity Index for PsA (DAPSA) Score
Timeframe: Up to visit 5 (Approximately 24 months)
7
Effectiveness for cDMARDs, tDMARDs, bDMARDs: Assessed by MDA