Ireland
--:--IST
Active, not recruiting Observational

Assessment of the Quality of Life of Multiple Sclerosis Patients Treated With Ofatumumab in Real-life in France

NCT06157086 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-12-21
Last updated
2026-04-29

Condition(s) studied

Multiple Sclerosis (MS)

Investigational drug(s) / intervention(s)

ofatumumab

ofatumumab: There is no treatment allocation. Participants with MS that initiated treatment with ofatumumabas per neurologist practice and regardless of the study protocol

Study summary

SEPROS is a non-interventional study, based on primary data collection of MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female, 18 years of age or older 2. Patient with confirmed MS diagnosis 3. Patient initiating treatment with ofatumumab for the first time 4. Patient for which the decision to initiate treatment with ofatumumab was made by the doctor (investigator) in accordance with his/her usual practices independently of the study 5. Patient not opposed to participation in this study 6. Patient willing and able to complete patient questionnaires Exclusion Criteria: 1\. Patient treated with ofatumumab in the context of a clinical trial

Primary outcome measure(s)

  • Quality of life - MUSIQoL questionnaire — 12 months
    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.

Trial sites (49)

FacilityCityRegionStatus
Novartis Investigative Site Angers France
Novartis Investigative Site Paris France
Novartis Investigative Site Agen France
Novartis Investigative Site Altkirch France
Novartis Investigative Site Amiens France
Novartis Investigative Site Belfort France
Novartis Investigative Site Bordeaux France
Novartis Investigative Site Boulogne-sur-Mer France
Novartis Investigative Site Brest France
Novartis Investigative Site Brunstatt Didenheim France
Novartis Investigative Site Cahors France
Novartis Investigative Site Chambéry France
Novartis Investigative Site Cherbourg Octeville France
Novartis Investigative Site Compiègne France
Novartis Investigative Site Contamine-sur-Arve France
Novartis Investigative Site Dax France
Novartis Investigative Site Gonesse France
Novartis Investigative Site Le Bouscat France
Novartis Investigative Site Le Coudray France
Novartis Investigative Site Lens France
Novartis Investigative Site Libourne France
Novartis Investigative Site Lille France
Novartis Investigative Site Lille France
Novartis Investigative Site Lyon France
Novartis Investigative Site Lyon France
Novartis Investigative Site Mantes-la-Jolie France
Novartis Investigative Site Marseille 01 France
Novartis Investigative Site Meaux France
Novartis Investigative Site Metz-Tessy France
Novartis Investigative Site Mont-de-Marsan France
Novartis Investigative Site Montluçon France
Novartis Investigative Site Montpellier France
Novartis Investigative Site Mulhouse France
Novartis Investigative Site Nîmes France
Novartis Investigative Site Orsay France
Novartis Investigative Site Paris France
Novartis Investigative Site Paris France
Novartis Investigative Site Poissy France
Novartis Investigative Site Quint-Fonsegrives France
Novartis Investigative Site Reims France

+ 9 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06157086 on ClinicalTrials.gov ↗ ← All trials in France