Evaluating the quality of life for multiple sclerosis patients treated with ofatumumab in France
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.
This study is trying to see how the medication ofatumumab affects the quality of life for adults with multiple sclerosis in France over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 294 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | ofatumumab |
| Locations | 43 sites (Agen 09 and 42 other locations) |
| Trial ID | NCT06157086 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the quality of life of adult patients with multiple sclerosis (MS) who have initiated treatment with ofatumumab, a medication prescribed by their neurologists. Conducted across multiple centers in metropolitan France, the study collects primary data from patients over a 12-month period following the start of treatment. Participants will be monitored for changes in their quality of life, providing valuable insights into the real-world effectiveness of ofatumumab in managing MS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a confirmed diagnosis of multiple sclerosis and are starting treatment with ofatumumab for the first time.
Not a fit: Patients who have previously received ofatumumab as part of a clinical trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide important information on how ofatumumab impacts the quality of life for MS patients in real-world settings.
How similar studies have performed: While this study focuses on real-world data collection, similar studies assessing the quality of life in MS patients treated with other therapies have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Agen 09 and 42 other locations
- Novartis Investigative Site — Agen 09, France (Recruiting)
- Novartis Investigative Site — Altkirch, France (Recruiting)
- Novartis Investigative Site — Amiens, France (Recruiting)
- Novartis Investigative Site — Angers Cedex 9, France (Recruiting)
- Novartis Investigative Site — Bethune, France (Recruiting)
- Novartis Investigative Site — Bordeaux Cedex, France (Recruiting)
- Novartis Investigative Site — Brest, France (Recruiting)
- Novartis Investigative Site — Cahors, France (Recruiting)
- Novartis Investigative Site — Chambery cedex, France (Recruiting)
- Novartis Investigative Site — Compiegne, France (Recruiting)
- Novartis Investigative Site — Contamine Sur Arve, France (Recruiting)
- Novartis Investigative Site — Dax, France (Recruiting)
- Novartis Investigative Site — La Rochelle, France (Recruiting)
- Novartis Investigative Site — La Seyne Sur Mer, France (Recruiting)
- Novartis Investigative Site — Le Bouscat, France (Recruiting)
- Novartis Investigative Site — Le Coudray, France (Recruiting)
- Novartis Investigative Site — Lens, France (Recruiting)
- Novartis Investigative Site — Libourne, France (Recruiting)
- Novartis Investigative Site — Lille, France (Recruiting)
- Novartis Investigative Site — Lyon, France (Recruiting)
- Novartis Investigative Site — Mantes La Jolie, France (Recruiting)
- Novartis Investigative Site — Marseille 01, France (Recruiting)
- Novartis Investigative Site — Mont de Marsan cedex, France (Recruiting)
- Novartis Investigative Site — Montlucon, France (Recruiting)
- Novartis Investigative Site — Montpellier, France (Recruiting)
- Novartis Investigative Site — Mulhouse, France (Recruiting)
- Novartis Investigative Site — Nimes, France (Recruiting)
- Novartis Investigative Site — Orsay, France (Recruiting)
- Novartis Investigative Site — Paris Cedex 12, France (Recruiting)
- Novartis Investigative Site — Paris, France (Recruiting)
- Novartis Investigative Site — Pointe A Pitre, France (Recruiting)
- Novartis Investigative Site — Poissy, France (Recruiting)
- Novartis Investigative Site — Pringy, France (Recruiting)
- Novartis Investigative Site — Reims, France (Recruiting)
- Novartis Investigative Site — Rennes, France (Recruiting)
- Novartis Investigative Site — Saint Maur Des Fosses, France (Recruiting)
- Novartis Investigative Site — Saverne, France (Recruiting)
- Novartis Investigative Site — Selestat, France (Recruiting)
- Novartis Investigative Site — Strasbourg, France (Recruiting)
- Novartis Investigative Site — Toulouse Cedex 9, France (Recruiting)
- Novartis Investigative Site — Tours, France (Recruiting)
- Novartis Investigative Site — Valence Cedex 9, France (Recruiting)
- Novartis Investigative Site — Villeurbanne, France (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.