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
- Diseases
- Ankylosing spondylitis
- 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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Besancon - Hopital Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Not yet recruiting |
| CHU Bordeaux - Hopital Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| CHRU Brest - Hôpital de la Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Not yet recruiting |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| CHU Clermont Ferrand - Hôpital Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Active, not recruiting |
| AP-HP Hopital Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| CHD Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Active, not recruiting |
| AP-HP Hopital Bicetre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Recruiting |
| CH Le Mans Coordinator of this site? Confirm its status | Le Mans | France | Active, not recruiting |
| GHICL - Hopital Saint-Philibert Coordinator of this site? Confirm its status | Lomme | France | Not yet recruiting |
| AP-HM - Hôpital St Marguerite Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| AP-HP Hopital Lariboisiere Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| AP-HP Höpital la Pitié-Salpétrière Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| AP-HP Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| AP-HP - Hôpital Saint-Antoine Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| HCL - Hôpital Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| CHU Rouen Hopital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| CHU Saint-Etienne - Hopital Nord Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Not yet recruiting |
| CHU Strasbourg - Hôpital de Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Hopitaux de Toulouse (CHU) - Hôpital Pierre Paul Riquet Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CHU Tours - Hôpital Trousseau Coordinator of this site? Confirm its status | Tours | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.