Influence of Therapeutic Failure on the Psychosocial Experience in Multiple Sclerosis

NCT07372599 | Not Yet Recruiting

• 1 other identifier: 2025-A01541-48
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Multiple Sclerosis

Keywords

Patient-reported-outcome; Patient-reported-experience; Quality of life; Socioeconomic status; Therapeutic failure; Multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (4)

• Psychological distress : The Hospital Anxiety and Depression Scale (HADS)

  2 years

• Well-being : The ICEpop CAPability measure for Adults (ICECAP-A)

  2 years

• Activity levels: The self-administered iMTA Productivity Cost Questionnaire (iPCQ)

  2 years

• Quality of care: MusiCare

  2 years

Study Arms (2)

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.

Other: Questionnaires

Absence of Therapeutic Failure

Other: Questionnaires

Interventions

Questionnaires OTHER

At inclusion (T0), TE if event occurs and T1: Completion of 5 questionnaires (MusiQoL, HADS, ICECAP-A, iPCQ, MusiCare).

Absence of Therapeutic Failure; Occurrence of Therapeutic Failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead
• University Hospital, Lille: collaborator
• University Hospital, Rouen: collaborator
• Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France: collaborator
• Centre Hospitalier Universitaire, Amiens: collaborator

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Pierre Branger, MD

CONTACT

+33231064617; branger-p@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 28, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: February 6, 2026

Record last verified: 2025-12