Clinical trial NCT06157086: Assessment of the Quality of Life of Multiple Sclerosis Patients Treated With Ofatumumab in Real-life in France
Official title: This is a Non-interventional, Prospective, Multicenter Study Conducted in France. The Primary Objective of This Study is to Describe the Quality of Life of MS Patients After Initiation of Treatment With Ofatumumab.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis (MS)
Keywords: MS
Multiple sclerosis
NIS
ofatumumab
Kesimpta
QoL
PRO
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-12-05
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 ®).

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.

Detailed description: This is a non-interventional, prospective (primary data), multicenter study conducted in metropolitan France. The primary objective of this study is to describe the quality of life of MS patients after initiation of treatment with ofatumumab.

In order to form a representative sample of MS patients taking into account the terms of care in France, free or practicing neurologists in healthcare institutions (public or private) in different regions of France will be selected to participate in this study.

The study will enroll adult patients with MS who initiated ofatumumab according to the physician's advice and independently of the study. Patients will be followed from initiation of ofatumumab either until (i) 12 months (± 1month) after initiation of ofatumumab (End of Study), or until (ii) discontinuation of treatment with ofatumumab prior to the completion of the 12-month follow-up (early termination); whichever occurs first (end of study or early termination).

Eligibility criteria: 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 outcomes:
measure: Quality of life - MUSIQoL questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Treatment satisfaction of patients treated with ofatumumab using TSQM 9 questionnaire
timeFrame: 12 months
measure: Impact of MS on professional activity using the 6-item WPAI questionnaire
timeFrame: 12 months
measure: Neurologist's decision criteria for initiating ofatumumab and patient involvement in the treatment choice
timeFrame: Baseline
measure: Clinical evolution of Multiple sclerosis - EDSS score
timeFrame: 12 months
measure: Clinical evolution of Multiple sclerosis - Number of patients with relapses
timeFrame: Up to 12 months
measure: Number of patient adherent to ofatumumab from patient and practitioner perspectives
timeFrame: 12 months
measure: Ofatumumab discontinuation
timeFrame: 12 months
measure: Persistence on ofatumumab
timeFrame: Month 6, Month 12
Other outcomes:
Locations:
city: Agen 09
country: France
facility: Novartis Investigative Site
city: Altkirch
country: France
facility: Novartis Investigative Site
city: Amiens
country: France
facility: Novartis Investigative Site
city: Angers Cedex 9
country: France
facility: Novartis Investigative Site
city: Bethune
country: France
facility: Novartis Investigative Site
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Cahors
country: France
facility: Novartis Investigative Site
city: Chambery cedex
country: France
facility: Novartis Investigative Site
city: Compiegne
country: France
facility: Novartis Investigative Site
city: Contamine Sur Arve
country: France
facility: Novartis Investigative Site
city: Dax
country: France
facility: Novartis Investigative Site
city: La Rochelle
country: France
facility: Novartis Investigative Site
city: La Seyne Sur Mer
country: France
facility: Novartis Investigative Site
city: Le Bouscat
country: France
facility: Novartis Investigative Site
city: Le Coudray
country: France
facility: Novartis Investigative Site
city: Lens
country: France
facility: Novartis Investigative Site
city: Libourne
country: France
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Mantes La Jolie
country: France
facility: Novartis Investigative Site
city: Marseille 01
country: France
facility: Novartis Investigative Site
city: Mont de Marsan cedex
country: France
facility: Novartis Investigative Site
city: Montlucon
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Mulhouse
country: France
facility: Novartis Investigative Site
city: Nimes
country: France
facility: Novartis Investigative Site
city: Orsay
country: France
facility: Novartis Investigative Site
city: Paris Cedex 12
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Pointe A Pitre
country: France
facility: Novartis Investigative Site
city: Poissy
country: France
facility: Novartis Investigative Site
city: Pringy
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: Saint Maur Des Fosses
country: France
facility: Novartis Investigative Site
city: Saverne
country: France
facility: Novartis Investigative Site
city: Selestat
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 9
country: France
facility: Novartis Investigative Site
city: Tours
country: France
facility: Novartis Investigative Site
city: Valence Cedex 9
country: France
facility: Novartis Investigative Site
city: Villeurbanne
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: