Early standardized global review for people with axial spondyloarthritis

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

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.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Association de Recherche Clinique en Rhumatologie (Academic / other)
• Locations: 21 sites (Besançon and 20 other locations)
• Trial ID: NCT07141017 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Besançon and 20 other locations

• 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 Caen — Caen, France (Recruiting)
• CHU Clermont-Ferrand - Hôpital Gabriel-Montpied — Clermont-Ferrand, France (Active_not_recruiting)
• AP-HP - Hôpital Henri Mondor — Créteil, France (Recruiting)
• CHD Vendée — La Roche-sur-Yon, France (Active_not_recruiting)
• AP-HP - Hôpital Bicêtre — Le Kremlin-Bicêtre, France (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 Cochin — Paris, France (Recruiting)
• AP-HP - Hôpital La Pitié Salpétrière — Paris, France (Recruiting)
• AP-HP - Hôpital Lariboisière — Paris, France (Not_yet_recruiting)
• AP-HP - Hôpital Saint Antoine — Paris, France (Recruiting)
• HCL - Hôpital Lyon Sud — Pierre-Bénite, France (Recruiting)
• CHU Rouen - Hôpital Charles-Nicolle — Rouen, France (Recruiting)
• CHU Saint Etienne - Hôpital Nord — Saint-Priest-en-Jarez, France (Not_yet_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)

Study contacts

• Study coordinator: Anna Molto

Conditions Axial Spondylarthritis; Rheumatology; Initial standardized global review