Axial SpondyloarthritisCOMEDSPANCT02374749
COMorbidities and EDucation in SPondyloArthritis Study
A study testing self-assessment/self-management and Comorbidities (detection/prevention) in people with Axial Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Giving both the gap existing between the current recommendations to prevent/detect comorbidities and the clinical practice in patients suffering from spondyloarthritis and also the specificity of some recommendations to rheumatic diseases, it seems logical to check these recommendations in a rheumatologic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- self-assessment/self-management and Comorbidities (detection/prevention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2015to 16 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male or female over 18 and under 80 years
- Axial Spondyloarthritis according to the ASAS criteria (Assessment of SpondyloArthritis international Society)
- Disease duration of at least one year
- Activity of SpA to be stable according to the treating rheumatologist for at least three months before the date of inclusion
- Lack of elective surgery during the 6 months after inclusion
- Able to understand and adhere to the study treatments
- Development of a medical examination results given to the patient
- Informed Consent signed and dated
Who cannot join
- Pregnant women (any method of contraception will be accepted)
- Patients who have had a change in the treatment of SpA during the 3 months prior to inclusion
- History of alcoholism, drug addiction, psychological problems, severe comorbidities that could possibly invalidate informed consent or limit patient compliance with the study protocol
- No affiliation to a social security regime
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COmorbidities and EDucation in SpondyloArthritis Study (COMEDSPA) Evaluation of Standardized Follow-up in Axial Spondyloarthritis
Giving both the gap existing between the current recommendations to prevent/detect comorbidities and the clinical practice in patients suffering from spondyloarthritis and also the specificity of some recommendations to rheumatic diseases, it seems logical to check these recommendations in a rheumatologic "environment".
This study with its two parts should be able to demonstrate:
- The importance of a systematic evaluation of comorbidities in Spondyloarthritis,
- The utility of a nurse-led program of self-assessment and self-management of the disease
Read the detailed description
Patients with spondyloarthritis will be invited by their rheumatologists to participate at this study in 21 centers in France.
500 patients are planned to be included.
After written informed consent will be obtained, the patients will be randomized in two arms:
- comorbidities
- self-assessment/self-management The patients will be seen again in the same center 12 months later in order to collect the outcome measures
The two primary objectives of this trial are :
- To evaluate the impact of a nurse led program of self-assessment of disease activity/severity and self-management on the level of satisfaction/coping
- To evaluate the impact of a nurse led program of assessment of comorbidities on the management of such comorbidities
The Secondary objectives are:
- To evaluate the prevalence of comorbidities in SpA;
- To evaluate the level of adherence to recommendations of prevention of comorbidities;
- To evaluate the impact of the nurse led program of self-assessment / self-management on the amount of NSAID (Non-steroidal Anti-Inflammatory Drugs) intake and the level of disability (e.g. functional disability)
- Conditions
- Axial Spondyloarthritis
- Being tested
- self-assessment/self-management, Comorbidities (detection/prevention)
- Keywords
- Axial Spondyloarthritis, Education, Co-morbidities, Nurse
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-assessment/self-managementBehavioural
Nurse led-program of self-assessment/ self-management of spondyloarthritis
Comorbidities (detection/prevention)Behavioural
Standardized assessment of comorbidities by nurses
| Study group | Role | What they receive |
|---|---|---|
| comorbidities | Active comparator | Evaluation of the prevalence and the presence of the risks factors of the four most frequently observed comorbidities in spondyloarthritis (cardiovascular diseases, cancers, infections osteoporosis and gastro-intestinal) as it is recommended by the French Society of Rheumatology. Receives: Behavioral: Comorbidities (detection/prevention) |
| self-assessment | Active comparator | During the initial visit, the clinical research nurse exempt a learning program of assessment of disease activity/severity :
* for assessing the activity in SpA;
* for the calculation of BASDAI and the ASDAS-CRP
* for the transfer technique and for the calculation of the disease activity on a monthly basis during the next 12 months.
* for the risk of tobacco exposure
* for the benefit of an NSAID intake in case of painful episode of the disease
* for the benefit of home exercises
* for the spine and indication of a treatment under the supervision of a physiotherapist in case of severe disease
* for learning the patient to calculate his BASDAI and ASDAS-CRP Then, the patient will return home with his calculator and his notebook. Each month, the patient will be asked to perform the BASDAI and ASDAS-CRP calculations and to report the data on the notebook. 12 months later, the patient comes for a visit in the current practice to assess both such program and comorbidities. Receives: Behavioral: self-assessment/self-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comorbidities
Changes after 12 months in the comorbidity composite score. Such composite score has been established prior the study and is taking into account the optimal management of patients (e.g. Normal blood pressure, no smoking,....) . Such score will be calculated at baseline and at the one year visit in the two groups.
Measured: 1 year later
self-assessment/self-management
The level of coping after 12 months based on the question#8 ( 0-10 NRS) of the RAID score. Such outcome will be evaluated at both the baseline and the one year visits in both groups.
Measured: 1 year later
Secondary outcomes (4)
Frequency of comorbidities in Spondyloarthritis
This analysis will be purely descriptive and will include the percentage of patients with:
- History of cardiovascular diseases
- Hypertension
- Diabetes
- Hyperlipidemia
- History of skin cancer, colon, uterus, breast, prostate
- Percentage of patients at high risk of cancers when these risks are known (eg, family history of breast cancer, colon)
- History of tuberculosis, HIV, or hospitalization for severe infections.
Measured: 1 year later
Frequency of compliance with general recommendations on vaccinations, screening for certain cancers and osteoporosis screening
The percentage of patients adhering to these recommendations will be assessed.
Measured: 1 year later
Impact of self-assessment by the patient of his/her Spondyloarthritis activity (ASDAS-CRP (C Reactive Protein), BASDAI) on the activity and severity of the disease
The final value of BASDAI and ASDAS-CRP will be compared in the two groups of patients by adjusting the analysis of the initial value.
The final visit BASFI value will be compared in the two groups of patients by adjusting the analysis of the initial value
Measured: 1 year later
Patient compliance program self-management of Spondyloarthritis
Compliance will be assessed by the percentage of the collections of the disease activity (BASDAI, ASDAS-CRP) actually made by the patient with regard the theoretical number one (e.g. monthly).
Measured: 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study start23 Mar 2015
- Primary completion16 Oct 2017
- Study completion16 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Maxime DOUGADOS, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374749
- Sponsor's protocol ID
- P140401
- Acronym
- COMEDSPA
- Status last verified
- Aug 2025
- First submitted
- 1 Jan 2015
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Molto A, Gossec L, Poiraudeau S, Claudepierre P, Soubrier M, Fayet F, Wendling D, Gaudin P, Dernis E, Guis S, Pouplin S, Ruyssen-Witrand A, Chales G, Mariette X, Beauvais C, Combe B, Flipo RM, Richette P, Chary-Valckenaere I, Saraux A, Sibilia J, Schaeverbeke T, Dougados M. Evaluation of the impact of a nurse-led program of patient self-assessment and self-management in axial spondyloarthritis: results of a prospective, multicentre, randomized, controlled trial (COMEDSPA). Rheumatology (Oxford). 2021 Feb 1;60(2):888-895. doi: 10.1093/rheumatology/keaa480.
PubMed 33063096Molto A, Gossec L, Poiraudeau S, Claudepierre P, Soubrier M, Fayet F, Wendling D, Gaudin P, Dernis E, Guis S, Pouplin S, Ruyssen A, Chales G, Mariette X, Beauvais C, Combe B, Flipo RM, Richette P, Chary-Valckenaere I, Saraux A, Sibilia J, Schaeverbeke T, Dougados M. Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial. Semin Arthritis Rheum. 2020 Aug;50(4):701-708. doi: 10.1016/j.semarthrit.2020.05.012. Epub 2020 May 27.
PubMed 32521324
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmorbidities and EDucation in SpondyloArthritis Study (COMEDSPA) Evaluation of Standardized Follow-up in Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT02374749
- Acronym / sponsor ID
- COMEDSPA / P140401
- Conditions
- Axial Spondyloarthritis
- Keywords
- Axial Spondyloarthritis, Education, Co-morbidities, Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 2 Mar 2015 (estimated)
- 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.
Giving both the gap existing between the current recommendations to prevent/detect comorbidities and the clinical practice in patients suffering from spondyloarthritis and also the specificity of some recommendations to rheumatic diseases, it seems logical to check these recommendations in a rheumatologic "environment".
This study with its two parts should be able to demonstrate:
- The importance of a systematic evaluation of comorbidities in Spondyloarthritis,
- The utility of a nurse-led program of self-assessment and self-management of the disease
Detailed description
Patients with spondyloarthritis will be invited by their rheumatologists to participate at this study in 21 centers in France.
500 patients are planned to be included.
After written informed consent will be obtained, the patients will be randomized in two arms:
- comorbidities
- self-assessment/self-management The patients will be seen again in the same center 12 months later in order to collect the outcome measures
The two primary objectives of this trial are :
- To evaluate the impact of a nurse led program of self-assessment of disease activity/severity and self-management on the level of satisfaction/coping
- To evaluate the impact of a nurse led program of assessment of comorbidities on the management of such comorbidities
The Secondary objectives are:
- To evaluate the prevalence of comorbidities in SpA;
- To evaluate the level of adherence to recommendations of prevention of comorbidities;
- To evaluate the impact of the nurse led program of self-assessment / self-management on the amount of NSAID (Non-steroidal Anti-Inflammatory Drugs) intake and the level of disability (e.g. functional disability)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comorbidities | Active comparator | Behavioral: Comorbidities (detection/prevention)Evaluation of the prevalence and the presence of the risks factors of the four most frequently observed comorbidities in spondyloarthritis (cardiovascular diseases, cancers, infections osteoporosis and gastro-intestinal) as it is recommended by the French Society of Rheumatology. |
| self-assessment | Active comparator | Behavioral: self-assessment/self-managementDuring the initial visit, the clinical research nurse exempt a learning program of assessment of disease activity/severity : * for assessing the activity in SpA; * for the calculation of BASDAI and the ASDAS-CRP * for the transfer technique and for the calculation of the disease activity on a monthly basis during the next 12 months. * for the risk of tobacco exposure * for the benefit of an NSAID intake in case of painful episode of the disease * for the benefit of home exercises * for the spine and indication of a treatment under the supervision of a physiotherapist in case of severe disease * for learning the patient to calculate his BASDAI and ASDAS-CRP Then, the patient will return home with his calculator and his notebook. Each month, the patient will be asked to perform the BASDAI and ASDAS-CRP calculations and to report the data on the notebook. 12 months later, the patient comes for a visit in the current practice to assess both such program and comorbidities. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female over 18 and under 80 years
- Axial Spondyloarthritis according to the ASAS criteria (Assessment of SpondyloArthritis international Society)
- Disease duration of at least one year
- Activity of SpA to be stable according to the treating rheumatologist for at least three months before the date of inclusion
- Lack of elective surgery during the 6 months after inclusion
Key exclusion criteria (5 listed)
- Pregnant women (any method of contraception will be accepted)
- Patients who have had a change in the treatment of SpA during the 3 months prior to inclusion
- History of alcoholism, drug addiction, psychological problems, severe comorbidities that could possibly invalidate informed consent or limit patient compliance with the study protocol
- No affiliation to a social security regime
- -
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 |
|---|---|---|
| self-assessment/self-managementNurse led-program of self-assessment/ self-management of spondyloarthritis | Behavioural | self-assessment |
| Comorbidities (detection/prevention)Standardized assessment of comorbidities by nurses | Behavioural | comorbidities |
Primary outcome
Comorbidities
Time frame: 1 year later
Changes after 12 months in the comorbidity composite score. Such composite score has been established prior the study and is taking into account the optimal management of patients (e.g. Normal blood pressure, no smoking,....) . Such score will be calculated at baseline and at the one year visit in the two groups.
self-assessment/self-management
Time frame: 1 year later
The level of coping after 12 months based on the question#8 ( 0-10 NRS) of the RAID score. Such outcome will be evaluated at both the baseline and the one year visits in both groups.
4 secondary outcomes
Frequency of comorbidities in Spondyloarthritis
Time frame: 1 year later
Frequency of compliance with general recommendations on vaccinations, screening for certain cancers and osteoporosis screening
Time frame: 1 year later
Impact of self-assessment by the patient of his/her Spondyloarthritis activity (ASDAS-CRP (C Reactive Protein), BASDAI) on the activity and severity of the disease
Time frame: 1 year later
Patient compliance program self-management of Spondyloarthritis
Time frame: 1 year later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 33063096Molto A, Gossec L, Poiraudeau S, Claudepierre P, Soubrier M, Fayet F, Wendling D, Gaudin P, Dernis E, Guis S, Pouplin S, Ruyssen-Witrand A, Chales G, Mariette X, Beauvais C, Combe B, Flipo RM, Richette P, Chary-Valckenaere I, Saraux A, Sibilia J, Schaeverbeke T, Dougados M. Evaluation of the impact of a nurse-led program of patient self-assessment and self-management in axial spondyloarthritis: results of a prospective, multicentre, randomized, controlled trial (COMEDSPA). Rheumatology (Oxford). 2021 Feb 1;60(2):888-895. doi: 10.1093/rheumatology/keaa480.
- Results publication: PubMed 32521324Molto A, Gossec L, Poiraudeau S, Claudepierre P, Soubrier M, Fayet F, Wendling D, Gaudin P, Dernis E, Guis S, Pouplin S, Ruyssen A, Chales G, Mariette X, Beauvais C, Combe B, Flipo RM, Richette P, Chary-Valckenaere I, Saraux A, Sibilia J, Schaeverbeke T, Dougados M. Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial. Semin Arthritis Rheum. 2020 Aug;50(4):701-708. doi: 10.1016/j.semarthrit.2020.05.012. Epub 2020 May 27.
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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. This study is not recruiting at the moment.
Maxime DOUGADOS, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-assessment/self-management and Comorbidities (detection/prevention) in people with Axial Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comorbidities (time frame: 1 year later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374749, which also lists 2 linked publications.
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 5 Sep 2025.