Initial Standardized Global Review in Axial Spondyloarthritis

NCT07141017 | Recruiting

• 1 other identifier: 2024-A02314-43
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Axial Spondylarthritis (axSpA)

Keywords

Rheumatology; Initial standardized global review

Outcome Measures

Primary Outcomes (1)

• The change in patient knowledge of the disease.

  The primary endpoint will be the change in the SPAKE questionnaire

  Visits Day 0 and Month 12

Secondary Outcomes (12)

• Treatment

  Visits Day 0 and Month 12

• The ability to cope with the disease

  Visits Day 0 and Month 12

• Knowledge on b/tsDMARDs

  Visits Day 0 and Month 12

• Adherence to axSpA treatments

  Visits Day 0 and Month 12

• Disease activity

  Visits Day 0 and Month 12

Study Arms (2)

Intervention arm

EXPERIMENTAL

Other: Initial standardized global review

Usual care arm

NO INTERVENTION

Interventions

Initial standardized global review OTHER

The intervention under study will be the initial standardized global review, which will be performed as soon as axial spondyloarthritis is diagnosed (less than 12 months from diagnosis is mandatory) and only at the baseline visit. This review includes both the assessment of different domains of the disease, but also the education and information on such different domains of the disease and its management The domains assessed during the intervention will be: diagnosis of spondyloarthritis, spondyloarthritis phenotype, disease activity, disease severity and function, treatment adherence and comorbidities. At the end of the intervention, a detailed medical report on this initial standardized global review will be produced and sent to the patient, their rheumatologist, their general practitioner, and their dispensing pharmacist.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Association de Recherche Clinique en Rhumatologie: lead
• RCTs: collaborator

Study Sites (21)

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

Central Study Contacts

Anna Molto

CONTACT

+33158412576; anna.molto@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a cluster-randomized, controlled study with two parallel arms

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 26, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

FR (21)