A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis (FILAXOS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 489
- Locations
- 88
- Primary Endpoint
- Proportion of patients with high serum neurofilament light (sNfL) levels
Study Overview
Brief Summary
This is a prospective, multicenter, observational, non-interventional study (NIS) in patients with Multiple Sclerosis (MS) and routinely assessed serum neurofilament light (sNfL) values in Germany
Detailed Description
Prospective, primary data will be collected from patients with sNfL outcomes in the context of switching to ofatumumab or continuing their current therapy. Data collection will cover a maximum period of 24 months.
The observational period will not be dictated by the protocol. Baseline and follow-up visits will take place at a frequency defined as per Investigator´s discretion following clinical routine. The diagnostic or monitoring procedures are only those ordinarily applied to therapeutic strategy and routine clinical care. During the observation phase of the study, data will be collected according to standard of care as recommended by KKNMS (Competence Network Multiple Sclerosis in Germany).
Eligible participants for the study are patients who have received treatment with category 1 DMTs and those who have included sNfL into their treatment decision-making process. These patients have the option to either continue their current DMT or switch to ofatumumab. According to local treatment guidelines, DMT category 1 include dimethylfumarate/diroximelfumarate, glatirameroids, Interferon beta and teriflunomide. The decision to switch to ofatumumab or to continue the current DMT category 1 therapy must be made by the treating physician independently of the decision to enroll the patient in the study.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants eligible for inclusion in this study must meet all the following criteria:
- •Written informed consent must be obtained before participation in the study.
- •RMS patients aged 18 or older.
- •Treated in label with EU-approved DMTs for MS category 1 according to current guidelines (Hemmer et al 2023) for at least the last 3 months.
- •Presence of a sNfL test result from a commercially available test not older than 3 months.
Exclusion Criteria
- •Participants meeting any of the following criteria are not eligible for inclusion in this study:
- •Patients being treated outside of the approved label of the respective DMT.
- •Simultaneous participation in any interventional study or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab.
Arms & Interventions
Ofatumumab
Patients who have received treatment with category 1 DMTs and decided to switch to ofatumumab
Intervention: ofatumumab (Other)
Category 1 DMTs
Patients who continued with DMT category 1 treatment. According to local treatment guidelines, DMT category 1 include dimethylfumarate/diroximelfumarate, glatirameroids, Interferon beta and teriflunomide.
Intervention: DMT category 1 (Other)
Outcomes
Primary Outcomes
Proportion of patients with high serum neurofilament light (sNfL) levels
Time Frame: Up to 24 months
Proportion of patients with high serum neurofilament light (sNfL) levels within 24 months of observation
Secondary Outcomes
- Proportion of patients perceived as clinically stable depending on sNfL level(Up to 24 months)
- Number of participants using Ekiva MS App(Up to 24 months)
- Proportion of patients with no evidence of disease activity (NEDA)(Baseline, month 12 and month 24)
- Reasons for and proportion of patients switching from current DMTs to ofatumumab(Up to 24 months)
- Reasons for, number of and duration of treatment interruptions and discontinuations.(Up to 24 months)
- sNfL use as a biomarker for Multiple Sclerosis disease activity in clinical practice(Up to 24 months)
- Proportion of patients demonstrating radiological and / or clinical activity(Up to 24 months)
- Treatment Satisfaction Questionnaire for Medication (TSQM) score(Up to 24 months)
- Proportion of patients demonstrating NEDA 3 and its individual components at 24 months as compared to Baseline(Baseline, 24 months)
- EuroQol- 5 Dimension (EQ-5D) score(Up to 24 months)
- Proportion of patients who continue to receive their initial treatment(Month 12 and month 24)
- Duration of treatment interruptions and discontinuations.(Up to 24 months)
- Characterization of patient subgroups with and without 100% adherence(Month 12)
- Proportion of missed ofatumumab doses within one year,(Month 12)
- Multiple sclerosis impact scale 29 (MSIS-29)(Up to 24 months)
- Fatigue questionnaire: Fatigue Scale for Motor and Cognitive Functions (FSMC)(Up to 24 months)