Initial Standardized Global Review in Axial Spondyloarthritis
NCT ID: NCT07141017
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
154 participants
INTERVENTIONAL
2025-05-12
2027-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intervention arm
Initial standardized global review
The intervention under study will be the initial standardized global review, which will be performed as soon as axial spondyloarthritis is diagnosed (less than 12 months from diagnosis is mandatory) and only at the baseline visit.
This review includes both the assessment of different domains of the disease, but also the education and information on such different domains of the disease and its management
The domains assessed during the intervention will be: diagnosis of spondyloarthritis, spondyloarthritis phenotype, disease activity, disease severity and function, treatment adherence and comorbidities.
At the end of the intervention, a detailed medical report on this initial standardized global review will be produced and sent to the patient, their rheumatologist, their general practitioner, and their dispensing pharmacist.
Usual care arm
No interventions assigned to this group
Interventions
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Initial standardized global review
The intervention under study will be the initial standardized global review, which will be performed as soon as axial spondyloarthritis is diagnosed (less than 12 months from diagnosis is mandatory) and only at the baseline visit.
This review includes both the assessment of different domains of the disease, but also the education and information on such different domains of the disease and its management
The domains assessed during the intervention will be: diagnosis of spondyloarthritis, spondyloarthritis phenotype, disease activity, disease severity and function, treatment adherence and comorbidities.
At the end of the intervention, a detailed medical report on this initial standardized global review will be produced and sent to the patient, their rheumatologist, their general practitioner, and their dispensing pharmacist.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
80 Years
ALL
No
Sponsors
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RCTs
INDUSTRY
Association de Recherche Clinique en Rhumatologie
OTHER
Responsible Party
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Locations
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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
CH Le Mans
Le Mans, , France
GHICL - Hôpital Saint Philibert
Lomme, , France
AP-HM - Hôpital St Marguerite
Marseille, , France
AP-HP - Hôpital Cochin
Paris, , France
AP-HP - Hôpital La Pitié Salpétrière
Paris, , France
AP-HP - Hôpital Lariboisière
Paris, , France
AP-HP - Hôpital Saint Antoine
Paris, , France
HCL - Hôpital Lyon Sud
Pierre-Bénite, , France
CHU Rouen - Hôpital Charles-Nicolle
Rouen, , France
CHU Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, , France
CHU Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
Hopitaux de Toulouse (CHU) - Hôpital Pierre Paul Riquet
Toulouse, , France
CHU Tours - Hôpital Trousseau
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-A02314-43
Identifier Type: -
Identifier Source: org_study_id
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