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Early Standardized Review Study for Patients With Axial Spondyloarthritis

Tests a standardized early review and education visit in adults newly diagnosed with axial spondyloarthritis.

Plain-language title generated from the registry record
Registry title: Initial Standardized Global Review in Axial Spondyloarthritis

Key facts

Where
Besançon, Bordeaux, Brest, Caen, Clermont-Ferrand, Créteil, La Roche-sur-Yon, Le Kremlin-Bicêtre, Le Mans, Lomme, Marseille, Paris, Pierre-Bénite, Rouen, Saint-Priest-en-Jarez, Strasbourg, Toulouse, and Tours, FranceSee the 21 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Source: NCT07141017, who can take part

Where in France

  • CHU Besancon - Hopital Jean MinjozBesançon, FranceNot yet recruiting
  • CHU Bordeaux - Hopital PellegrinBordeaux, FranceNot yet recruiting
  • CHRU Brest - Hôpital de la Cavale BlancheBrest, FranceNot yet recruiting
  • CHU CaenCaen, FranceTaking people
  • CHU Clermont Ferrand - Hôpital Gabriel MontpiedClermont-Ferrand, FranceNo longer taking part
  • AP-HP Hopital Henri MondorCréteil, FranceTaking people
  • CHD VendéeLa Roche-sur-Yon, FranceNo longer taking part
  • AP-HP Hopital BicetreLe Kremlin-Bicêtre, FranceTaking people
  • CH Le MansLe Mans, FranceNo longer taking part
  • GHICL - Hopital Saint-PhilibertLomme, FranceNot yet recruiting
  • AP-HM - Hôpital St MargueriteMarseille, FranceNo longer taking part
  • AP-HP - Hôpital Saint-AntoineParis, FranceTaking people
  • AP-HP Hôpital CochinParis, FranceTaking people
  • AP-HP Höpital la Pitié-SalpétrièreParis, FranceTaking people
  • AP-HP Hopital LariboisiereParis, FranceNot yet recruiting
  • HCL - Hôpital Lyon SudPierre-Bénite, FranceTaking people
  • CHU Rouen Hopital Charles NicolleRouen, FranceTaking people
  • CHU Saint-Etienne - Hopital NordSaint-Priest-en-Jarez, FranceNot yet recruiting
  • CHU Strasbourg - Hôpital de HautepierreStrasbourg, FranceTaking people
  • Hopitaux de Toulouse (CHU) - Hôpital Pierre Paul RiquetToulouse, FranceTaking people
  • CHU Tours - Hôpital TrousseauTours, FranceTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Association de Recherche Clinique en Rhumatologie
Trial code
NCT07141017
Record updated
26 August 2025
Original description
This study will be a pragmatic, cluster-randomized, controlled study with two parallel arms ( 'intervention' and 'usual care' (UC) arms) of one year duration.Read full original descriptionShow less

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

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.

Inclusion: 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: 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).

ClinicalTrials.gov NCT07141017