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NCT07141017Recruiting

Initial Standardized Global Review in Axial Spondyloarthritis

Evaluating the Impact of an Initial Standardized Global Review in Patients With Early Axial Spondyloarthritis: a Multicenter Randomized Cluster-controlled Study

Source: ClinicalTrials.gov · Last updated 26 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
154 (estimated)
First submitted
29 Jul 2025
Start date
12 May 2025
Primary completion date
31 May 2027
Lead sponsor
Association de Recherche Clinique en Rhumatologie
NCT number
NCT07141017

What you commit to

  • Study type: Interventional
  • Planned participants: 154
  • From 12 May 2025 to the primary completion date, 31 May 2027
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Besancon - Hopital Jean Minjoz
Coordinator of this site? Confirm its status
BesançonFranceNot yet recruiting
CHU Bordeaux - Hopital Pellegrin
Coordinator of this site? Confirm its status
BordeauxFranceNot yet recruiting
CHRU Brest - Hôpital de la Cavale Blanche
Coordinator of this site? Confirm its status
BrestFranceNot yet recruiting
CHU Caen
Coordinator of this site? Confirm its status
CaenFranceRecruiting
CHU Clermont Ferrand - Hôpital Gabriel Montpied
Coordinator of this site? Confirm its status
Clermont-FerrandFranceActive, not recruiting
AP-HP Hopital Henri Mondor
Coordinator of this site? Confirm its status
CréteilFranceRecruiting
CHD Vendée
Coordinator of this site? Confirm its status
La Roche-sur-YonFranceActive, not recruiting
AP-HP Hopital Bicetre
Coordinator of this site? Confirm its status
Le Kremlin-BicêtreFranceRecruiting
CH Le Mans
Coordinator of this site? Confirm its status
Le MansFranceActive, not recruiting
GHICL - Hopital Saint-Philibert
Coordinator of this site? Confirm its status
LommeFranceNot yet recruiting
AP-HM - Hôpital St Marguerite
Coordinator of this site? Confirm its status
MarseilleFranceActive, not recruiting
AP-HP Hopital Lariboisiere
Coordinator of this site? Confirm its status
ParisFranceNot yet recruiting
AP-HP Höpital la Pitié-Salpétrière
Coordinator of this site? Confirm its status
ParisFranceRecruiting
AP-HP Hôpital Cochin
Coordinator of this site? Confirm its status
ParisFranceRecruiting
AP-HP - Hôpital Saint-Antoine
Coordinator of this site? Confirm its status
ParisFranceRecruiting
HCL - Hôpital Lyon Sud
Coordinator of this site? Confirm its status
Pierre-BéniteFranceRecruiting
CHU Rouen Hopital Charles Nicolle
Coordinator of this site? Confirm its status
RouenFranceRecruiting
CHU Saint-Etienne - Hopital Nord
Coordinator of this site? Confirm its status
Saint-Priest-en-JarezFranceNot yet recruiting
CHU Strasbourg - Hôpital de Hautepierre
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting
Hopitaux de Toulouse (CHU) - Hôpital Pierre Paul Riquet
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
CHU Tours - Hôpital Trousseau
Coordinator of this site? Confirm its status
ToursFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.