Clinical trial Recruiting at 11 sites Interventional Ages 18 to 80

Early standardized global review for people with axial spondyloarthritis

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

Run by Association de Recherche Clinique en Rhumatologie · NCT07141017 · Data updated 2026-11-12

This study will test whether giving a standardized global review (including disease assessments and education) soon after diagnosis helps adults with recent axial spondyloarthritis improve their knowledge over 12 months.

More Axial Spondylarthritis (axSpA) trials

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment154 (estimated)
SponsorAssociation de Recherche Clinique en Rhumatologie
Academic / other
Locations21 sites (Besançon and 20 other locations)
StatusRecruiting
StartedMay 12, 2025
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedAugust 26, 2025
Trial IDNCT07141017 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults under 80 years old diagnosed with axial spondyloarthritis within the past 12 months who can complete study activities and have not already received a dedicated global evaluation or education program are ideal candidates.

Probably not a fit

Patients who have already undergone a similar dedicated education or global evaluation, or who have cognitive, psychiatric, or substance-use conditions that limit understanding or adherence, are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pragmatic, cluster-randomized, controlled, open-label study lasting one year that compares centers delivering an early standardized global review to centers providing usual care. Centers are randomized (not individual patients), and control centers are not informed about the intervention details to limit bias. The intervention includes assessment of disease domains and patient education, and the primary outcome is change in the SPAKE knowledge questionnaire between baseline and 12 months. Eligible participants are adults diagnosed with axSpA within the prior 12 months who can complete study activities, while those who already received a dedicated education/global evaluation or who have conditions limiting understanding or adherence are excluded.

Why it matters

Potential benefit: If successful, this approach could improve patients' understanding of axSpA, supporting better self-management and treatment decisions.

How similar studies have gone: Previous educational and structured-review programs in rheumatology and other chronic inflammatory diseases have improved patient knowledge and sometimes outcomes, but applying a standardized global review specifically in early axSpA is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

  • CHU Caen
    Caen, France
    Recruiting
  • AP-HP - Hôpital Henri Mondor
    Créteil, France
    Recruiting
  • AP-HP - Hôpital Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • AP-HP - Hôpital Cochin
    Paris, France
    Recruiting
  • AP-HP - Hôpital La Pitié Salpétrière
    Paris, France
    Recruiting
  • AP-HP - Hôpital Saint Antoine
    Paris, France
    Recruiting
Show 15 more locations
  • HCL - Hôpital Lyon Sud
    Pierre-Bénite, France
    Recruiting
  • CHU Rouen - Hôpital Charles-Nicolle
    Rouen, France
    Recruiting
  • CHU Strasbourg - Hôpital de Hautepierre
    Strasbourg, France
    Recruiting
  • Hopitaux de Toulouse (CHU) - Hôpital Pierre Paul Riquet
    Toulouse, France
    Recruiting
  • CHU Tours - Hôpital Trousseau
    Tours, France
    Recruiting
  • CHU Besançon - Hôpital Jean Minjoz
    Besançon, France
    Not yet recruiting
  • CHU Bordeaux - Hôpital Pellegrin
    Bordeaux, France
    Not yet recruiting
  • CHRU Brest - Hôpital de La Cavale Blanche
    Brest, France
    Not yet recruiting
  • CHU Clermont-Ferrand - Hôpital Gabriel-Montpied
    Clermont-Ferrand, France
    Active not recruiting
  • CHD Vendée
    La Roche-sur-Yon, France
    Active not recruiting
  • CH Le Mans
    Le Mans, France
    Active not recruiting
  • GHICL - Hôpital Saint Philibert
    Lomme, France
    Not yet recruiting
  • AP-HM - Hôpital St Marguerite
    Marseille, France
    Active not recruiting
  • AP-HP - Hôpital Lariboisière
    Paris, France
    Not yet recruiting
  • CHU Saint Etienne - Hôpital Nord
    Saint-Priest-en-Jarez, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.