This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany.
Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years. Additionally, medical history of participants will be collected including disease duration, laboratory values, EDSS, MRI parameters and relapses.
Signed informed consent must be obtained prior to participation in the study
Male or female patients aged ≥18 years at enrollment
Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)
RMS with active disease as defined by Lublin et al. (2014)
Patients being treated outside of the approved label
> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment
Previous therapy with any DMT for the treatment of MS prior to enrollment (except within the past 14 days with an approved injectable DMT for MS as routine medical treatment; see Inclusion criteria #7)
Relapse prior to enrollment which has led to a severe deficit relevant to everyday life upon discretion of the investigator after exhaustion of the relapse therapy
patients with planned initiation or initiation within the past 14 days with an approved injectable or oral DMT for MS as routine medical treatment
Cohort
Prospective
ofatumumab
Other interventionThere is no treatment allocation. Patients administered ofatumumab by prescription that have started as routine medical treatment will be enrolled.
glatiramer acetate
Other interventionThere is no treatment allocation. Patients administered glatiramer acetate by prescription that have started as routine medical treatment will be enrolled.
interferon β1
Other interventionThere is no treatment allocation. Patients administered interferon β1 by prescription that have started as routine medical treatment will be enrolled.
teriflunomide
Other interventionThere is no treatment allocation. Patients administered teriflunomide by prescription that have started as routine medical treatment will be enrolled.
dimethyl fumarate (DMF)
Other interventionThere is no treatment allocation. Patients administered dimethyl fumarate (DMF) by prescription that have started as routine medical treatment will be enrolled.
diroximel fumarate (DRF)
Other interventionThere is no treatment allocation. Patients administered diroximel fumarate (DRF) by prescription that have started as routine medical treatment will be enrolled.
Proportion of patients who continue to receive their baseline treatment
Proportion of patients who continue to receive their baseline treatment \[ofatumumab or other approved disease modifying therapies (IFN-β1, GA, teriflunomide, DMF or DRF)\]
Proportion of patients who continue to receive their baseline treatment
Proportion of patients who continue to receive their baseline treatment \[ofatumumab or other approved disease modifying therapies (IFN-β1, GA, teriflunomide, DMF or DRF)\]
Time to event analysis for retention time on baseline treatment
Time-to-event analysis for retention time on baseline treatment \[ofatumumab or other approved disease modifying therapies (IFN-β1, GA, teriflunomide, DMF or DRF)\]
Impact of first-line treatment on health economy
Mean annual health care resource utilization cost, annual direct medical costs, annual direct nonmedical costs and annual indirect costs as measured by MS Health Resource Utilization Survey \[MS-HRS\] MS-HRS is a 24-item questionnaire covers societal resource use, regardless of the issue of reimbursement, as well as impact of the disease on work, family and leisure. With the help of this questionnaire a monetary value can be assigned to e.g. the stage of MS, a relapse or a therapy.
Fatigue Symptoms and Impact Questionnaire-RMS
Fatigue Symptoms and Impact Questionnaire-RMS \[FSIQ-RMS\] The FSIQ-RMS comprises 20 items organized in a conceptual framework with 2 symptom domains (energy, muscle weakness) and 7 impact domains (daily activities, cognition, emotions, physical impact, self-care, sleep, social impact) in order to measure fatigue symptoms and impacts in relapsing multiple sclerosis. A scoring algorithm standardizes scores on both the symptoms domain (daily and weekly) and impacts subdomains (weekly) to a 0 to 100 scale, with higher scores indicating more severe symptoms and impacts. There is no single summary score across the FSIQ-RMS instrument, but rather 1 symptoms score and 3 impacts subdomain scores.
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