Multiple SclerosisINPSYSEPNCT07372599
Influence of Therapeutic Failure on the Psychosocial Experience in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University Hospital, Caen.
Trial summary
Multiple sclerosis (MS), an inflammatory, neurodegenerative disease of the central nervous system, affects around 120,000 patients in France and is the leading cause of non-traumatic disability in young adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Questionnaires
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Aug 2029
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RRMS patients aged 18 or over with uninterrupted use of a moderately effective treatment, or highly effective treatment only if it is the first DMT, for at least 6 months.
Who may be able to join
- Patient aged 18 or over.
- Patient with RRMS according to McDonald 2024 criteria.
- Uninterrupted use of a moderately effective treatment, or highly effective treatment only if it is the first DMT, for at least 6 months.
- Collection of non-objection.
- Patient affiliated to the social security system.
Who cannot join
- Patient with progressive MS.
- Patient treated continuously with the same DMT for 3 years or more.
- Patient who received a second line DMT or an immunosuppressant before taking a first line DMT.
- Patients who have received mitoxantrone as the first treatment
- Pregnant or breast-feeding woman at the time of inclusion.
- Severe cognitive and/or psychological disorders which, according to the investigator (with or without a neuropsychological assessment), prevent the participant from completing the self-questionnaires independently and accurately.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Influence of Therapeutic Failure on the Psychosocial Experience of Patients With Relapsing-remitting Multiple Sclerosis
Multiple sclerosis (MS), an inflammatory, neurodegenerative disease of the central nervous system, affects around 120,000 patients in France and is the leading cause of non-traumatic disability in young adults. It affects patients' health-related quality of life (QoL) and has a significant economic impact on patients and society as a whole. Early initiation of disease-modifying therapy (DMT) is recommended in relapsing-remitting MS (RRMS). Nevertheless, according to a recent French cohort, 30% of patients initially treated with a first-line FT will switch to a highly effective compound within 5 years due to its ineffectiveness. Therapeutic failure (Th-F) is therefore a frequent occurrence, but its psychological, social and economic consequences are poorly understood. These elements are generally the subject of measurements reported by patients, and several studies have highlighted the importance of taking them into account in the management of these patients.
Here, the investigators will study two categories of these measures in a Th-F situation. On the one hand, patient-reported outcome measurements (PROMs) will be examined. Patients' psychological distress and their QoL are two important examples of psychosocial impacts in patients with MS, compared to the general population. The impact on activity levels is also well known, but the specific effect of Th-F has not yet been studied. On the other hand, patients' experiences of their care pathway and their opinion on the quality of care (patient-reported experience measurement [PREM]) will also be studied. Some PREMs refer to care coordination, satisfaction with the relationship with carers or doctors' empathy levels. To date, data on the experience of MS patients regarding their care pathway remains limited and non-existent during Th-F.
Read more
Finally, the influence of socioeconomic status (SES) on PROMs and PREMs is worth considering. In the general population, patients' experience of care can be influenced by their socioeconomic status. Compared with research on other diseases (notably cardiovascular diseases and cancers), there is relatively little work on the association between socioeconomic status and MS and none has focused on the topic of Th-F.
The investigators therefore hypothesise that a quality of care perceived favourably by MS patients may moderate the negative impact of Th-F on their QoL, anxiety/depression and activity levels (as recently described in oncology), and a more recent measure of abilities assessing well-being defined in a broad sense, as a function of their SES.
- Conditions
- Multiple Sclerosis
- Being tested
- Questionnaires
- Keywords
- Patient-reported-outcome, Patient-reported-experience, Quality of life, Socioeconomic status, Therapeutic failure, Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
At inclusion (T0), TE if event occurs and T1: Completion of 5 questionnaires (MusiQoL, HADS, ICECAP-A, iPCQ, MusiCare).
| Study group | Role | What they receive |
|---|---|---|
| Occurrence of Therapeutic Failure | Occurrence of Therapeutic Failure : Change or discontinuation of the DMT decided by the treating neurologist, linked to a progression of the disease characterised by inflammatory activity (clinical and/or radiological) and/or progression of the disease unrelated to inflammatory activity. Receives: Other: Questionnaires | |
| Absence of Therapeutic Failure | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life : The International Multiple Sclerosis Quality of Life Questionnaire (MusiQoL)
The International Multiple Sclerosis Quality of Life Questionnaire (MusiQoL) is a multidimensional, self-administered questionnaire that has been developed internationally (including a French version). It comprises 31 questions describing nine dimensions (daily activities, psychological well-being, relationships with friends, symptoms, relationships with family, relationships with the healthcare system, emotional and sexual life, adaptation, and rejection). Each item is scored from 1 to 5. The score of each dimension is obtained by computing the mean of the item scores of the dimension. All dimension scores are linearly transformed to a 0-100 scale. A higher score indicates a higher level of health-related quality of life.
Measured: 2 years
Secondary outcomes (4)
Psychological distress : The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is validated in French. It contains 14 items divided into two dimensions (anxiety and depression). Each item is scored from 0 to 3. The score for each subscale is the sum of the 7 items (ranging from 0-21). A higher score indicates a higher distress. This questionnaire has already been used with MS patients and has shown good psychometric indicators.
Measured: 2 years
Well-being : The ICEpop CAPability measure for Adults (ICECAP-A)
The ICEpop CAPability measure for Adults (ICECAP-A) is a measure of the capability of the general adult population (18+) intended for use in economic evaluation and focused on well-being in the broad sense, rather than health. ICECAP-A comprises five attributes (attachment, stability, fulfilment, pleasure, autonomy). Each item is scored from 1 to 4. The total score is the sum of the 5 attributes (ranging 5-20). A higher score indicates a higher quality of life/capability. Qualitative and quantitative studies on the validity of ICECAP-A have been carried out and a French translation of ICECAP-A has been developed for the general population.
Measured: 2 years
Activity levels: The self-administered iMTA Productivity Cost Questionnaire (iPCQ)
The self-administered iMTA Productivity Cost Questionnaire (iPCQ) measure the impact of the disease on market and household activities. This recently validated questionnaire, available in French, comprises 18 items, of which 9 are general questions to collect demographic information, such as age, sex and respondents' work status. iPCQ includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work.
Measured: 2 years
Quality of care: MusiCare
MusiCare is the only French-language questionnaire specific to MS for assessing the quality of care as perceived by MS patients and their careers. It comprises 35-item encompassing 5 domains: information about the disease (11), information about the treatments/medical investigations (8), relationships with healthcare teams (8), healthcare access (5) and reception conditions in care centers (3). Each item is scored from 1 to 5. All dimension scores are linearly transformed and standardized using a scale ranging from 0 to 100. A higher score indicates a higher self-perceived care management quality.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, Groupement des Hôpitaux de l'Institut Catholique de Lille, Centre Hospitalier Universitaire, Amiens, University Hospital, Rouen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372599
- Sponsor's protocol ID
- 2025-A01541-48
- Acronym
- INPSYSEP
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Therapeutic Failure on the Psychosocial Experience of Patients With Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07372599
- Acronym / sponsor ID
- INPSYSEP / 2025-A01541-48
- Conditions
- Multiple Sclerosis
- Keywords
- Patient-reported-outcome, Patient-reported-experience, Quality of life, Socioeconomic status, Therapeutic failure, Multiple sclerosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- University Hospital, Lille, Groupement des Hôpitaux de l'Institut Catholique de Lille, Centre Hospitalier Universitaire, Amiens, University Hospital, Rouen
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 28 Jan 2026 (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.
Multiple sclerosis (MS), an inflammatory, neurodegenerative disease of the central nervous system, affects around 120,000 patients in France and is the leading cause of non-traumatic disability in young adults. It affects patients' health-related quality of life (QoL) and has a significant economic impact on patients and society as a whole. Early initiation of disease-modifying therapy (DMT) is recommended in relapsing-remitting MS (RRMS). Nevertheless, according to a recent French cohort, 30% of patients initially treated with a first-line FT will switch to a highly effective compound within 5 years due to its ineffectiveness. Therapeutic failure (Th-F) is therefore a frequent occurrence, but its psychological, social and economic consequences are poorly understood. These elements are generally the subject of measurements reported by patients, and several studies have highlighted the importance of taking them into account in the management of these patients.
Here, the investigators will study two categories of these measures in a Th-F situation. On the one hand, patient-reported outcome measurements (PROMs) will be examined. Patients' psychological distress and their QoL are two important examples of psychosocial impacts in patients with MS, compared to the general population. The impact on activity levels is also well known, but the specific effect of Th-F has not yet been studied. On the other hand, patients' experiences of their care pathway and their opinion on the quality of care (patient-reported experience measurement [PREM]) will also be studied. Some PREMs refer to care coordination, satisfaction with the relationship with carers or doctors' empathy levels. To date, data on the experience of MS patients regarding their care pathway remains limited and non-existent during Th-F.
Finally, the influence of socioeconomic status (SES) on PROMs and PREMs is worth considering. In the general population, patients' experience of care can be influenced by their socioeconomic status. Compared with research on other diseases (notably cardiovascular diseases and cancers), there is relatively little work on the association between socioeconomic status and MS and none has focused on the topic of Th-F.
The investigators therefore hypothesise that a quality of care perceived favourably by MS patients may moderate the negative impact of Th-F on their QoL, anxiety/depression and activity levels (as recently described in oncology), and a more recent measure of abilities assessing well-being defined in a broad sense, as a function of their SES.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occurrence of Therapeutic Failure | – | Other: QuestionnairesOccurrence of Therapeutic Failure : Change or discontinuation of the DMT decided by the treating neurologist, linked to a progression of the disease characterised by inflammatory activity (clinical and/or radiological) and/or progression of the disease unrelated to inflammatory activity. |
| Absence of Therapeutic Failure | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RRMS patients aged 18 or over with uninterrupted use of a moderately effective treatment, or highly effective treatment only if it is the first DMT, for at least 6 months.
Key inclusion criteria (5 listed)
- Patient aged 18 or over.
- Patient with RRMS according to McDonald 2024 criteria.
- Uninterrupted use of a moderately effective treatment, or highly effective treatment only if it is the first DMT, for at least 6 months.
- Collection of non-objection.
- Patient affiliated to the social security system.
Key exclusion criteria (6 listed)
- Patient with progressive MS.
- Patient treated continuously with the same DMT for 3 years or more.
- Patient who received a second line DMT or an immunosuppressant before taking a first line DMT.
- Patients who have received mitoxantrone as the first treatment
- Pregnant or breast-feeding woman at the time of inclusion.
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 |
|---|---|---|
| QuestionnairesAt inclusion (T0), TE if event occurs and T1: Completion of 5 questionnaires (MusiQoL, HADS, ICECAP-A, iPCQ, MusiCare). | Other | Absence of Therapeutic Failure, Occurrence of Therapeutic Failure |
Primary outcome
Quality of life : The International Multiple Sclerosis Quality of Life Questionnaire (MusiQoL)
Time frame: 2 years
The International Multiple Sclerosis Quality of Life Questionnaire (MusiQoL) is a multidimensional, self-administered questionnaire that has been developed internationally (including a French version). It comprises 31 questions describing nine dimensions (daily activities, psychological well-being, relationships with friends, symptoms, relationships with family, relationships with the healthcare system, emotional and sexual life, adaptation, and rejection). Each item is scored from 1 to 5. The score of each dimension is obtained by computing the mean of the item scores of the dimension. All dimension scores are linearly transformed to a 0-100 scale. A higher score indicates a higher level of health-related quality of life.
4 secondary outcomes
Psychological distress : The Hospital Anxiety and Depression Scale (HADS)
Time frame: 2 years
Well-being : The ICEpop CAPability measure for Adults (ICECAP-A)
Time frame: 2 years
Activity levels: The self-administered iMTA Productivity Cost Questionnaire (iPCQ)
Time frame: 2 years
Quality of care: MusiCare
Time frame: 2 years
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 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Caen.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Pierre Branger, MD (+33231064617, branger-p@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life : The International Multiple Sclerosis Quality of Life Questionnaire (MusiQoL) (time frame: 2 years). 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 6 Feb 2026.