Radar des Essais Cliniques

Quality of life - MUSIQoL questionnaire

The primary objective of this non-interventional study is to describe the quality of life of adult patients with MS treated with ofatumumab in real life, in France, after 12 months of treatment with ofatumumab using the MUSIQoL Quality of Life Questionnaire. The MuSiQoL measures MS-specific quality of life. It comprises 31 items covering 9 domains (activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, relationships with the healthcare system, sentimental and sexual life, coping, and rejection). Each item is scored on a 6-point Likert scale. The score on each dimension is obtained by computing the mean of the item scores for that dimension. All dimension scores are linearly transformed to a 0-100 scale. The global index score is computed as the mean of the dimension scores. Higher scores represent higher quality of life.

12 months

Treatment satisfaction of patients treated with ofatumumab using TSQM 9 questionnaire

TSQM -9 is a self-questionnaire used to assess patient satisfaction with their treatment. It is a validated questionnaire and a good predictor of compliance. It explores 4 dimensions of satisfaction (efficacy, side effects, simplicity and overall satisfaction), through 9 questions. Responses are expressed on a 7-point Likert scale to precisely capture the patient's point of view. The responses to the items are aggregated; thus, each dimension is noted between 0 (extremely dissatisfied) and 100 (extremely satisfied).

12 months

Impact of MS on professional activity using the 6-item WPAI questionnaire

The WPAI measures absence, presence, decreased work productivity, and reduction in normal daily activities over the past 7 days. This self-questionnaire is non-specific for a disease and is developed in 6 questions. It works to calculate a health-related deterioration score, which combines the absence score and presence score. This deterioration score is rated between 0 and 1 where 1 corresponds to the maximum score, i.e. stopping work

12 months

Neurologist's decision criteria for initiating ofatumumab and patient involvement in the treatment choice

For each patient included in the study, neurologist's decision criteria for ofatumumab initiation will be collected (i.e., patient characteristics and poor prognosis factors or reasons for treatment switch if applicable) as well as the involvement of the patient in the choice of treatment (yes or no)

Baseline

Clinical evolution of Multiple sclerosis - EDSS score

The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.

12 months

Clinical evolution of Multiple sclerosis - Number of patients with relapses

Number of patients with relapses and number of patients with hospitalizations related to the relapse

Up to 12 months

Number of patient adherent to ofatumumab from patient and practitioner perspectives

Number of patient adherent to ofatumumab from patient and practitioner perspectives to be collected

12 months

Ofatumumab discontinuation

Ofatumumab discontinuation by reason to be collected

12 months

Persistence on ofatumumab

Patients still treated with ofatumumab at 6 and 12 months

Month 6, Month 12