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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 154 (estimated) |
| Sponsor | Association de Recherche Clinique en Rhumatologie Academic / other |
| Locations | 21 sites (Besançon and 20 other locations) |
| Status | Recruiting |
| Started | May 12, 2025 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT07141017 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
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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
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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
- Study coordinator: Anna Molto
- Email: anna.molto@aphp.fr
- Phone: +33158412576
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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FAPI‑74 PET/CT versus FDG PET/CT for inflammation in FUO, IgG4‑RD, and axial spondyloarthritis
This project will test whether [18F]-AlF-FAPI-74 PET/CT finds inflammation more accurately than standard [18F]-FDG PET/CT in people with fever of unknown origin, IgG4‑related disease, or axial spondyloarthritis.
-
Comparing five advanced treatments for axial spondyloarthritis and psoriatic arthritis
This project will see how well bimekizumab, risankizumab, guselkumab, upadacitinib, or a TNF inhibitor work for adults with axSpA or PsA who have just started one of these medicines, using medical records and patient surveys.
-
Personalized lab test to predict the best treatment for rheumatic diseases
This project tests a lab-based cell assay to see if it can predict which DMARD will work best for adults with autoimmune rheumatic diseases such as RA, PsA, axSpA, and GCA.
-
Evaluating movement recommendations for patients with axial spondyloarthritis using smartwatches
This study is testing how using smartwatches to track movement can help people with axial spondyloarthritis find better ways to stay active and manage their symptoms.
-
Validation of the 2025 Axial Spondyloarthritis Classification Criteria in Chinese patients
This study tests whether the 2025 ASAS-SPARTAN criteria correctly classify axial spondyloarthritis in adults with chronic back pain in China.
-
Lowering JAK inhibitor doses in people with RA, PsA, or axSpA who are in low disease activity or remission
This study will test whether carefully lowering the dose of Janus kinase inhibitors keeps disease control as well as staying on the same dose in people with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who are in remission or have low disease activity.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.