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Initial Standardized Global Review in Axial Spondyloarthritis

RecruitingNAAges 18 Years - 80 YearsAllAssociation de Recherche Clinique en Rhumatologie
NCT07141017 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study will be a pragmatic, cluster-randomized, controlled study with two parallel arms ( 'intervention' and 'usual care' (UC) arms) of one year duration. The study will be open-label, but centers randomized in the UC arm will not be aware of the intervention performed in the 'intervention' centers. The primary objective of this study will be to determine whether participation in a standardized global review (that includes assessment of disease domains and education ) as soon as possible after diagnosis of axial spondyloarthritis has a beneficial impact on patient knowledge of the disease at 12 months. The primary endpoint will be the change in the SPAKE (SPondyloArthritis Knowledge Questionnaire) questionnaire between M0 and M12.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults (but age \<80years) with a diagnosis of axial spondyloarthritis determined by the treating rheumatologist within the 12 months preceding the baseline visit, who have completed the informed consent and have the ability to complete all study activities. Exclusion Criteria: * Patients who have already received a specific (or plan to receive in the coming 12 months) and dedicated program/global evaluation including education on the disease or treatments. * Patients with any physical or mental condition that may affect understanding of the intervention or adherence to treatment (e.g. major depression or substance/alcohol use - might have impact on the outcomes of interest in the study).
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What it tests

  • Initial standardized global review
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Where

21 sites
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
CHU Bordeaux - Hôpital Pellegrin
Bordeaux, France
CHRU Brest - Hôpital de La Cavale Blanche
Brest, France
CHU Caen
Caen, France
CHU Clermont-Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand, France
AP-HP - Hôpital Henri Mondor
Créteil, France
CHD Vendée
La Roche-sur-Yon, France
AP-HP - Hôpital Bicêtre
Le Kremlin-Bicêtre, France

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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