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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis (MS)
• Intervention / Treatment: Other: ofatumumab

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).

• Study Type: Observational
• Enrollment (Estimated): 294

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• France
  • Altkirch, France, 68130
    • Recruiting
    • Novartis Investigative Site
  • Dax Cedex, France, 40107
    • Recruiting
    • Novartis Investigative Site
  • Lyon, France, 69275
    • Recruiting
    • Novartis Investigative Site
  • Mulhouse, France, 68100
    • Recruiting
    • Novartis Investigative Site
  • Valence Cedex 9, France, 26953
    • Recruiting
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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 ®).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ofatumumab; MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol	Other: ofatumumab; There is no treatment allocation. Participants with MS that initiated treatment with ofatumumabas per neurologist practice and regardless of the study protocol; Other Names: KESIMPTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2023
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: QoL; MS; Multiple sclerosis; ofatumumab; Kesimpta; NIS; PRO
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Antineoplastic Agents; Ofatumumab
• Other Study ID Numbers: COMB157GFR06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No