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

NCT06157086 | Active Not Recruiting

• 1 other identifier: COMB157GFR06
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 49

Brief 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.

Conditions

Multiple Sclerosis (MS)

Keywords

MS; Multiple sclerosis; NIS; ofatumumab; Kesimpta; QoL; PRO

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Treatment satisfaction of patients treated with ofatumumab using TSQM 9 questionnaire

  12 months

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

  12 months

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

  Baseline

• Clinical evolution of Multiple sclerosis - EDSS score

  12 months

• Clinical evolution of Multiple sclerosis - Number of patients with relapses

  Up to 12 months

Study Arms (1)

ofatumumab

MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol

Other: ofatumumab

Interventions

ofatumumab OTHER

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

Also known as: KESIMPTA

ofatumumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be adult patients with MS (women and men) who have initiated treatment with ofatumumab (Kesimpta ®).

You may qualify if:

• Male or female, 18 years of age or older
• Patient with confirmed MS diagnosis
• Patient initiating treatment with ofatumumab for the first time
• 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
• Patient not opposed to participation in this study
• Patient willing and able to complete patient questionnaires

You may not qualify if:

• \. Patient treated with ofatumumab in the context of a clinical trial

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (49)

Novartis Investigative Site

Angers, France, 49933, France

Location

Novartis Investigative Site

Paris, France, F-75571, France

Location

Novartis Investigative Site

Agen, 47923, France

Location

Novartis Investigative Site

Altkirch, 68130, France

Location

Novartis Investigative Site

Amiens, 80054, France

Location

Novartis Investigative Site

Belfort, 90000, France

Location

Novartis Investigative Site

Bordeaux, 33076, France

Location

Novartis Investigative Site

Boulogne-sur-Mer, 62200, France

Location

Novartis Investigative Site

Brest, 29200, France

Location

Novartis Investigative Site

Brunstatt Didenheim, 68350, France

Location

Novartis Investigative Site

Cahors, 46000, France

Location

Novartis Investigative Site

Chambéry, 73000, France

Location

Novartis Investigative Site

Cherbourg Octeville, 50102, France

Location

Novartis Investigative Site

Compiègne, 60200, France

Location

Novartis Investigative Site

Contamine-sur-Arve, 74130, France

Location

Novartis Investigative Site

Dax, 40107, France

Location

Novartis Investigative Site

Gonesse, 95503, France

Location

Novartis Investigative Site

Le Bouscat, 33110, France

Location

Novartis Investigative Site

Le Coudray, 28630, France

Location

Novartis Investigative Site

Lens, 62307, France

Location

Novartis Investigative Site

Libourne, 33505, France

Location

Novartis Investigative Site

Lille, 59000, France

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Lyon, 69008, France

Location

Novartis Investigative Site

Lyon, 69275, France

Location

Novartis Investigative Site

Mantes-la-Jolie, 78200, France

Location

Novartis Investigative Site

Marseille 01, 13001, France

Location

Novartis Investigative Site

Meaux, 77104, France

Location

Novartis Investigative Site

Metz-Tessy, 74374, France

Location

Novartis Investigative Site

Mont-de-Marsan, 40024, France

Location

Novartis Investigative Site

Montluçon, 03100, France

Location

Novartis Investigative Site

Montpellier, 34090, France

Location

Novartis Investigative Site

Mulhouse, 68100, France

Location

Novartis Investigative Site

Nîmes, 30029, France

Location

Novartis Investigative Site

Orsay, 91400, France

Location

Novartis Investigative Site

Paris, 75014, France

Location

Novartis Investigative Site

Paris, 75017, France

Location

Novartis Investigative Site

Poissy, 78303, France

Location

Novartis Investigative Site

Quint-Fonsegrives, 31130, France

Location

Novartis Investigative Site

Reims, 51092, France

Location

Novartis Investigative Site

Rennes, 35033, France

Location

Novartis Investigative Site

Saverne, 67700, France

Location

Novartis Investigative Site

Sélestat, 67600, France

Location

Novartis Investigative Site

Strasbourg, 67000, France

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Tours, 37044, France

Location

Novartis Investigative Site

Valence, 26953, France

Location

Novartis Investigative Site

Vannes, 56017, France

Location

Novartis Investigative Site

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: December 21, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (49)