Sinsheim

This observational study follows patients with relapsing multiple sclerosis RMS who are being treated with approved injectable or selected oral disease-modifying therapies DMTs in Germany. The study is non-interventional and open-label, designed to collect real-world data on treatment and disease progression over several years. It aims to understand how patients continue their baseline treatments and how these treatments impact various health and quality of life measures. Participants receive routine medical care with approved injectable or oral DMTs such as ofatumumab, interferon b21, glatiramer acetate, teriflunomide, dimethyl fumarate, or diroximel fumarate. The study includes two cohorts with up to approximately two years of prospective observation each, with an optional extension allowing up to four years total. Treatment decisions and monitoring follow the patients usual care and physicians discretion, including routine visits and telemedicine options. During the study, participants provide medical history, complete questionnaires, and have data collected on disability status, MRI findings, relapses, and laboratory tests. Researchers assess treatment continuation rates, fatigue, anxiety, depression, quality of life, lesion counts, and relapse rates at multiple time points. Safety and treatment interruptions are also documented. Follow-up is flexible and based on standard care procedures, with data collection occurring throughout the observational periods.

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

This research aims to evaluate participant satisfaction with subcutaneous ocrelizumab treatment in people with Multiple Sclerosis MS over a 12-month period. It will also investigate changes in neurofilament light chain NfL protein levels, a marker related to MS disease activity, and explore correlations between NfL levels and various clinical and imaging factors. The study is observational and follows participants who are starting ocrelizumab SC as part of their routine MS care. Participants will receive ocrelizumab as a subcutaneous injection according to their physicians discretion and local clinical practice. The study observes participants for up to 12 months to assess treatment satisfaction using the Therapy Administration Satisfaction Questionnaire for Subcutaneous administration TASQ-SC and other satisfaction questionnaires. Blood samples will be collected at baseline, month 6, and month 12 to measure NfL protein levels and other biomarkers. The study also monitors MS relapses, disability scores, and adverse events during this period. Throughout the 12 months, participants will undergo assessments of treatment satisfaction at multiple time points, including after the first injection, 6 months, and 12 months. Clinical evaluations, questionnaires, and blood tests will be conducted to track disease activity and participant experience. Researchers will measure satisfaction levels, changes in NfL concentrations, relapse rates, disability progression, and safety events. The study is designed to provide real-world data on patient experience and biomarker changes with subcutaneous ocrelizumab treatment in MS.