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NCT Number: NCT07141017

Initial Standardized Global Review in Axial Spondyloarthritis

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.

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Key information

Conditions

Axial Spondylarthritis (axSpA)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Besançon - Hôpital Jean Minjoz, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. The change in patient knowledge of the disease.

    Time frame: Visits Day 0 and Month 12

    The primary endpoint will be the change in the SPAKE questionnaire

Secondary outcomes

  1. Treatment

    Time frame: Visits Day 0 and Month 12

    Treatment in both groups will be evaluated NSAID intake and % of patients receiving csDMARD/bDMARD/tsDMARD

  2. The ability to cope with the disease

    Time frame: Visits Day 0 and Month 12

    The ability to cope with the disease will be evaluated by disease coping change between Day 0 and Month 12 in both groups using the Coping Scale from the RAID questionnaire

  3. Knowledge on b/tsDMARDs

    Time frame: Visits Day 0 and Month 12

    Knowledge on b/tsDMARDs, only in patients with b/tsDMARD, will be evaluated by the BioSECURE'21 questionnaire

  4. Adherence to axSpA treatments

    Time frame: Visits Day 0 and Month 12

    Adherence to axSpA treatments in both groups will be evaluated by the CQR5 questionnaire

  5. Disease activity

    Time frame: Visits Day 0 and Month 12

    Disease activity will be evaluated by the disease activity score (ASDAS) change in both groups

  6. Number of comorbidities

    Time frame: Visit Month 12

    Number of comorbidities managed according to recommendations in both groups

  7. Function change

    Time frame: Visits Day 0 and Month 12

    Function change in both groups between will be evaluated by the BASFI questionnaire

  8. Quality of life change

    Time frame: Visits Day 0 and Month 12

    Quality of life change in both groups will be evaluated by the ASAS-HI questionnaire

  9. Work impairment

    Time frame: Visit Month 12

    Work impairment will be evaluated by the WPAI questionnaire

  10. Assessment of health services resources use

    Time frame: Visit Month 12

    Assessment of health services resources use will be evaluated by self-questionnaire

  11. The patient's perception of the benefits of this type of initial global standardized review on patient's follow-up and the treating rheumatologist's perception of the benefits of this type of initial global standardized review on patient follow-up

    Time frame: Visit Month 12

    The patient's perception of the benefits of this type of initial global standardized review on patient's follow-up and the treating rheumatologist's perception of the benefits of this type of initial global standardized review on patient follow-up will be evaluated by the Likert scale

  12. The sources of information accessed by patients

    Time frame: Visits Day 0 and Month 12

    The sources of information accessed by patients in both groups be evaluated with the percentage of patients who participated in a therapeutic education programme

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Molto

CONTACT

[email protected]

+33158412576

Sponsors and collaborators

Lead sponsor

Association de Recherche Clinique en Rhumatologie

Other

Collaborators

  • RCTs

Registry information

Official study title

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

Acronym: REVINSPA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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