Hettingen

This research aims to observe patients with relapsing multiple sclerosis RMS who are being treated with approved injectable or selected oral disease-modifying therapies DMTs in Germany. The study collects data to understand how these treatments are used in routine care and their effects over time. It is an observational, non-interventional, multicenter, open-label study sponsored by Novartis Pharmaceuticals. Patients will be followed in two cohorts Cohort 1 includes patients starting or recently started on injectable DMTs, and Cohort 2 includes patients starting or recently started on either ofatumumab or other approved injectable or oral DMTs. The core observational period is up to two years, with an optional extension adding another two years, totaling up to about four years of observation. Treatment decisions are made independently by patients and their physicians, and no study-mandated treatment or monitoring is imposed. Participants will provide data through questionnaires and electronic case report forms, with medical history including disease duration, lab values, MRI results, and relapse information collected. Routine clinical care assessments and telemedicine visits may occur at the investigators discretion. The study measures include treatment continuation rates, disability scores, relapse rates, quality of life, fatigue, anxiety, depression, MRI lesion monitoring, and safety events, with follow-up visits scheduled as per standard care over the study period.

Researchers are conducting a prospective, multicenter, observational study in Germany to evaluate the clinical value and impact of serum neurofilament light sNfL as a prognostic marker for disease activity in patients with relapsing Multiple Sclerosis MS. The study focuses on patients who have received category 1 disease-modifying therapies DMTs and monitors routinely assessed sNfL values to better understand their role in patient management. Participants in the study either continue their current category 1 DMT treatment or switch to ofatumumab based on their physicians clinical judgment, independent of study enrollment. Category 1 DMTs include medications such as dimethylfumarate, diroximelfumarate, glatiramer acetate, interferon beta, and teriflunomide. Data will be collected over a maximum period of 24 months during routine clinical visits, with no specific protocol dictating observation frequency or diagnostic procedures. During the study, researchers will gather primary data including sNfL test results and track various outcomes like disease activity, treatment adherence, patient-reported fatigue, quality of life, and treatment satisfaction. Assessments will align with standard care practices and guidelines, and the study will measure outcomes at baseline, 12 months, and 24 months. The study aims to provide insights into the use of sNfL in clinical practice and its implications for managing relapsing MS.

This research aims to evaluate participant satisfaction with subcutaneous SC administration of ocrelizumab in people with multiple sclerosis MS. Participants include those diagnosed with relapsing-remitting MS RMS or primary progressive MS PPMS according to the 2017 McDonald criteria. The study focuses on assessing satisfaction after 12 months of treatment using the Therapy Administration Satisfaction Questionnaire subcutaneous TASQ-SC. Participants will receive ocrelizumab as a subcutaneous injection for the first time as part of their routine MS therapy, following their physicians judgment and local guidelines. The study observes treatment satisfaction over a 12-month period without altering standard care. Treatment administration is monitored in accordance with usual clinical practice. Throughout the study, participants will complete satisfaction questionnaires at baseline, 6 months, and 12 months. Researchers will also measure neurofilament light chain NfL protein levels in serum at these timepoints and analyze their correlations with MS relapse, disability scale scores, previous treatments, and other factors. Safety is monitored by recording adverse events up to 12 months. The study involves regular assessments to understand the effects of ocrelizumab SC on patient satisfaction and biological markers over one year.