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
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 Type
OBSERVATIONAL
Enrollment
700
This is an observational study. There is no treatment allocation. The decision to initiate ofatumumab will be based solely on clinical judgement.
This is an observational study. There is no treatment allocation. The decision to continue their current DMT will be based solely on clinical judgement.
Proportion of patients with high serum neurofilament light (sNfL) levels
Proportion of patients with high serum neurofilament light (sNfL) levels within 24 months of observation
Time frame: Up to 24 months
sNfL use as a biomarker for Multiple Sclerosis disease activity in clinical practice
Description of perception, utility, frequency of serum neurofilament light (sNfL) measurements and clinical consequences initiated by the treating physician in clinical routine care setting
Time frame: Up to 24 months
Proportion of patients demonstrating radiological and / or clinical activity
Proportion of patients demonstrating radiological (number of new/enlarging T2 lesions, number of Gadolinium-positive T1 lesions) and / or clinical activity (MS relapse, confirmed disability progression) at Baseline and throughout the study also in context with sNfL level.
Time frame: Up to 24 months
Proportion of patients with no evidence of disease activity (NEDA)
Proportion of patients with NEDA at 12 and 24 months as compared to Baseline also in context with sNfL level.
Time frame: Baseline, month 12 and month 24
Proportion of patients demonstrating NEDA 3 and its individual components at 24 months as compared to Baseline
NEDA is defined by no confirmed multiple sclerosis relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening.
Time frame: Baseline, 24 months
Proportion of patients perceived as clinically stable depending on sNfL level
Proportion of patients perceived as clinically stable depending on sNfL level
Novartis Pharmaceuticals
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Novartis Investigative Site
Albstadt, Baden-Wurttemberg, Germany
RECRUITINGNovartis Investigative Site
Hettingen, Baden-Wurttemberg, Germany
RECRUITINGNovartis Investigative Site
Mannheim, Baden-Wurttemberg, Germany
RECRUITINGNovartis Investigative Site
Schwetzingen, Baden-Wurttemberg, Germany
RECRUITINGNovartis Investigative Site
Bamberg, Bavaria, Germany
RECRUITINGNovartis Investigative Site
Neuburg A.d. Donau, Bavaria, Germany
RECRUITINGNovartis Investigative Site
Regensburg, Bavaria, Germany
RECRUITINGNovartis Investigative Site
Unterhaching, Bavaria, Germany
RECRUITINGNovartis Investigative Site
Untermeitingen, Bavaria, Germany
RECRUITINGNovartis Investigative Site
Weiden in Der Oberpfalz, Bavaria, Germany
RECRUITING...and 99 more locations
Time frame: Up to 24 months
Multiple sclerosis impact scale 29 (MSIS-29)
The Multiple Sclerosis Impact Scale version 2 will be used to assess health-related quality of life. MSIS-29 is a 29-item, self-administered questionnaire that includes two domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day-to-day life.
Time frame: Up to 24 months
Fatigue questionnaire: Fatigue Scale for Motor and Cognitive Functions (FSMC)
FSMC consists of 20 items (10 for cognitive fatigue \[FSMCcog\] and 10 for motor fatigue \[FSMCmot\]) with 1-5 points per item. The total possible score ranges from 20-100 points. A sum score of ≥43 is categorized as mild fatigue, ≥53 as moderate fatigue and ≥63 as severe fatigue.
Time frame: Up to 24 months
EuroQol- 5 Dimension (EQ-5D) score
This patient questionnaire is a generic multidimensional measure of health-related quality of life (EuroQol 1990). The five domains of mobility, ability to take care of oneself, everyday activities, pain/discomfort and anxiety/depression are considered. For each dimension, the most appropriate answer is selected from three given possibilities (1=no problem, 2=moderate problem, 3=big problem). In addition, the patient marks the current state of health on a scale from 0 (worst conceivable state of health) to 100 (best conceivable state of health).
Time frame: Up to 24 months
Number of participants using Ekiva MS App
Change in satisfaction scores and evaluation of improvement of patient-physician dialogue and Multiple Sclerosis patient management
Time frame: Up to 24 months
Treatment Satisfaction Questionnaire for Medication (TSQM) score
The TSQM Version 1.4 comprises 14 items across four domains focusing on effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items) of the medication over the previous 2-3 weeks, or since the subject´s last use. With the exception of item 4 (presence of side effects; yes or no), all items have 5 or 7 responses, scored from 1 (least satisfied) to 5 or 7 (most satisfied). The 7-item scales had a non-neutral midpoint, such that there were more positive response options than negative response options, to allow precise information to be obtained at the upper end of the score distribution. Item scores are summarized to give four domain scores, which are in turn transformed to a scale of 0-100.
Time frame: Up to 24 months
Reasons for and proportion of patients switching from current DMTs to ofatumumab
Reasons for and proportion of patients switching from current DMTs to ofatumumab depending on sNfL level
Time frame: Up to 24 months
Proportion of missed ofatumumab doses within one year,
Proportion of missed ofatumumab doses within one year, defined as the difference between number of planned doses and number of administered doses.
Time frame: Month 12
Proportion of patients who continue to receive their initial treatment
Proportion of patients who continue to receive their initial treatment (ofatumumab or DMT category 1)
Time frame: Month 12 and month 24
Reasons for, number of and duration of treatment interruptions and discontinuations.
Reasons for and number of treatment interruptions and discontinuations.
Time frame: Up to 24 months
Duration of treatment interruptions and discontinuations.
Duration of treatment interruptions and discontinuations.
Time frame: Up to 24 months
Characterization of patient subgroups with and without 100% adherence
Patients with matching number of planned doses and number of administered doses within 1 year (eg, previous experience with sub-cutaneous therapy)
Time frame: Month 12