Axial Spondylarthritis (axSpA)REVINSPANCT07141017
Initial Standardized Global Review in Axial Spondyloarthritis
A study testing Initial standardized global review in people with Axial Spondylarthritis (axSpA), run by Association de Recherche Clinique en Rhumatologie at 21 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Axial Spondylarthritis (axSpA)
- What is being tested?
- Initial standardized global review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 21 sitesFrance
- Study dates
- 12 May 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
France21 sites, 17 recruiting
- Not yet recruiting
CHU Besançon - Hôpital Jean Minjoz
Besançon
Daniel Wendling, dwendling@chu-besancon.fr
- Not yet recruiting
CHU Bordeaux - Hôpital Pellegrin
Bordeaux
Thierry Schaeverbeke, thierry.schaeverbeke@chu-bordeaux.fr
- Not yet recruiting
CHRU Brest - Hôpital de La Cavale Blanche
Brest
Alain Saraux, alain.saraux@chu-brest.fr
- Recruiting
CHU Caen
Caen
Emmanuelle Dernis, dernis-e@chu-caen.fr
- Active, not recruiting
CHU Clermont-Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand
- Recruiting
AP-HP - Hôpital Henri Mondor
Créteil
Laura Pina Vegas, laura.pinavegas@aphp.fr
- Active, not recruiting
CHD Vendée
La Roche-sur-Yon
- Recruiting
AP-HP - Hôpital Bicêtre
Le Kremlin-Bicêtre
Stéphan Pavy, stephan.pavy@aphp.fr
- Active, not recruiting
CH Le Mans
Le Mans
- Not yet recruiting
GHICL - Hôpital Saint Philibert
Lomme
Tristant Pascart, pascart.tristan@ghicl.net
- Active, not recruiting
AP-HM - Hôpital St Marguerite
Marseille
- Recruiting
AP-HP - Hôpital Cochin
Paris
Olivier Fogel, olivier.fogel@aphp.fr
- Recruiting
AP-HP - Hôpital La Pitié Salpétrière
Paris
Laure Gossec, laure.gossec@aphp.fr
- Not yet recruiting
AP-HP - Hôpital Lariboisière
Paris
Aline Frazier-Mironer, aline.frazier@aphp.fr
- Recruiting
AP-HP - Hôpital Saint Antoine
Paris
Ines Kouki, ines.kouki@aphp.fr
- Recruiting
HCL - Hôpital Lyon Sud
Pierre-Bénite
Cyrille Confavreux, cyrille.confavreux@chu-lyon.fr
- Recruiting
CHU Rouen - Hôpital Charles-Nicolle
Rouen
Thierry Lequerre, thierry.lequerre@chu-rouen.fr
- Not yet recruiting
CHU Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez
Hubert Marotte, hubert.marotte@chu-st-etienne.fr
- Recruiting
CHU Strasbourg - Hôpital de Hautepierre
Strasbourg
Christelle Sordet, christelle.sordet@chru-strasbourg.fr
- Recruiting
Hopitaux de Toulouse (CHU) - Hôpital Pierre Paul Riquet
Toulouse
Adeline Ruyssen Witrand, ruyssen-witrand.a@chu-toulouse.fr
- Recruiting
CHU Tours - Hôpital Trousseau
Tours
Philippe Goupille, philippe.goupille@univ-tours.fr
About this study
Official title: Evaluating the Impact of an Initial Standardized Global Review in Patients With Early Axial Spondyloarthritis: a Multicenter Randomized Cluster-controlled Study
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)
- Being tested
- Initial standardized global review
- Keywords
- Rheumatology, Initial standardized global review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial standardized global reviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Other: Initial standardized global review |
| Usual care arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in patient knowledge of the disease.
The primary endpoint will be the change in the SPAKE questionnaire
Measured: Visits Day 0 and Month 12
Secondary outcomes (12)
Treatment
Treatment in both groups will be evaluated NSAID intake and % of patients receiving csDMARD/bDMARD/tsDMARD
Measured: Visits Day 0 and Month 12
The ability to cope with the disease
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
Measured: Visits Day 0 and Month 12
Knowledge on b/tsDMARDs
Knowledge on b/tsDMARDs, only in patients with b/tsDMARD, will be evaluated by the BioSECURE'21 questionnaire
Measured: Visits Day 0 and Month 12
Adherence to axSpA treatments
Adherence to axSpA treatments in both groups will be evaluated by the CQR5 questionnaire
Measured: Visits Day 0 and Month 12
Disease activity
Disease activity will be evaluated by the disease activity score (ASDAS) change in both groups
Measured: Visits Day 0 and Month 12
Number of comorbidities
Number of comorbidities managed according to recommendations in both groups
Measured: Visit Month 12
Function change
Function change in both groups between will be evaluated by the BASFI questionnaire
Measured: Visits Day 0 and Month 12
Quality of life change
Quality of life change in both groups will be evaluated by the ASAS-HI questionnaire
Measured: Visits Day 0 and Month 12
Work impairment
Work impairment will be evaluated by the WPAI questionnaire
Measured: Visit Month 12
Assessment of health services resources use
Assessment of health services resources use will be evaluated by self-questionnaire
Measured: 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
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
Measured: Visit Month 12
The sources of information accessed by patients
The sources of information accessed by patients in both groups be evaluated with the percentage of patients who participated in a therapeutic education programme
Measured: Visits Day 0 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start12 May 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial Spondylarthritis (axSpA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a cluster-randomized, controlled study with two parallel arms
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association de Recherche Clinique en Rhumatologie
- Sponsor type
- University, hospital or other
- Collaborators
- RCTs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141017
- Sponsor's protocol ID
- 2024-A02314-43
- Acronym
- REVINSPA
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of an Initial Standardized Global Review in Patients With Early Axial Spondyloarthritis: a Multicenter Randomized Cluster-controlled Study
- ClinicalTrials.gov ID
- NCT07141017
- Acronym / sponsor ID
- REVINSPA / 2024-A02314-43
- Conditions
- Axial Spondylarthritis (axSpA)
- Keywords
- Rheumatology, Initial standardized global review
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Association de Recherche Clinique en RhumatologieUniversity, hospital or other
- Collaborators
- RCTs
- Study start
- 12 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a cluster-randomized, controlled study with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Initial standardized global review |
| Usual care arm | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial standardized global reviewThe 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. | Other | Intervention arm |
Primary outcome
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
12 secondary outcomes
Treatment
Time frame: Visits Day 0 and Month 12
The ability to cope with the disease
Time frame: Visits Day 0 and Month 12
Knowledge on b/tsDMARDs
Time frame: Visits Day 0 and Month 12
Adherence to axSpA treatments
Time frame: Visits Day 0 and Month 12
Disease activity
Time frame: Visits Day 0 and Month 12
Number of comorbidities
Time frame: Visit Month 12
Function change
Time frame: Visits Day 0 and Month 12
Quality of life change
Time frame: Visits Day 0 and Month 12
Work impairment
Time frame: Visit Month 12
Assessment of health services resources use
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
Time frame: Visit Month 12
The sources of information accessed by patients
Time frame: Visits Day 0 and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial standardized global review in people with Axial Spondylarthritis (axSpA), run by Association de Recherche Clinique en Rhumatologie at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Molto (+33158412576, anna.molto@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in patient knowledge of the disease. (time frame: Visits Day 0 and Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.