Initial Standardized Global Review in Axial Spondyloarthritis

NCT ID: NCT07141017

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2027-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Axial Spondylarthritis (axSpA)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be a cluster-randomized, controlled study with two parallel arms
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention arm

Group Type EXPERIMENTAL

Initial standardized global review

Intervention Type 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.

Usual care arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Initial standardized global review

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 Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RCTs

INDUSTRY

Sponsor Role collaborator

Association de Recherche Clinique en Rhumatologie

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Besançon - Hôpital Jean Minjoz

Besançon, , France

Site Status NOT_YET_RECRUITING

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, , France

Site Status NOT_YET_RECRUITING

CHRU Brest - Hôpital de La Cavale Blanche

Brest, , France

Site Status NOT_YET_RECRUITING

CHU Caen

Caen, , France

Site Status RECRUITING

CHU Clermont-Ferrand - Hôpital Gabriel-Montpied

Clermont-Ferrand, , France

Site Status ACTIVE_NOT_RECRUITING

AP-HP - Hôpital Henri Mondor

Créteil, , France

Site Status RECRUITING

CHD Vendée

La Roche-sur-Yon, , France

Site Status ACTIVE_NOT_RECRUITING

AP-HP - Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

CH Le Mans

Le Mans, , France

Site Status ACTIVE_NOT_RECRUITING

GHICL - Hôpital Saint Philibert

Lomme, , France

Site Status NOT_YET_RECRUITING

AP-HM - Hôpital St Marguerite

Marseille, , France

Site Status ACTIVE_NOT_RECRUITING

AP-HP - Hôpital Cochin

Paris, , France

Site Status RECRUITING

AP-HP - Hôpital La Pitié Salpétrière

Paris, , France

Site Status RECRUITING

AP-HP - Hôpital Lariboisière

Paris, , France

Site Status NOT_YET_RECRUITING

AP-HP - Hôpital Saint Antoine

Paris, , France

Site Status RECRUITING

HCL - Hôpital Lyon Sud

Pierre-Bénite, , France

Site Status RECRUITING

CHU Rouen - Hôpital Charles-Nicolle

Rouen, , France

Site Status RECRUITING

CHU Saint Etienne - Hôpital Nord

Saint-Priest-en-Jarez, , France

Site Status NOT_YET_RECRUITING

CHU Strasbourg - Hôpital de Hautepierre

Strasbourg, , France

Site Status RECRUITING

Hopitaux de Toulouse (CHU) - Hôpital Pierre Paul Riquet

Toulouse, , France

Site Status RECRUITING

CHU Tours - Hôpital Trousseau

Tours, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anna Molto

Role: CONTACT

+33158412576

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Daniel Wendling

Role: primary

Thierry Schaeverbeke

Role: primary

Alain Saraux

Role: primary

Emmanuelle Dernis

Role: primary

Laura Pina Vegas

Role: primary

Stéphan Pavy

Role: primary

Tristant Pascart

Role: primary

Olivier Fogel

Role: primary

Laure Gossec

Role: primary

Aline Frazier-Mironer

Role: primary

Ines Kouki

Role: primary

Cyrille Confavreux

Role: primary

Thierry Lequerre

Role: primary

Hubert Marotte

Role: primary

Christelle Sordet

Role: primary

Adeline Ruyssen Witrand

Role: primary

Philippe Goupille

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-A02314-43

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of SPY072 in Rheumatic Disease
NCT07148414 RECRUITING PHASE2