Sinsheim

Researchers are evaluating the clinical utility of serum neurofilament light (sNfL) as a prognostic marker for disease activity in patients with relapsing multiple sclerosis (MS). This prospective, multicenter, observational, non-interventional study in Germany aims to understand how sNfL values can influence patient management and treatment decisions. The study focuses on patients treated with category 1 disease-modifying therapies (DMTs) who have incorporated sNfL testing into their care. Participants will either continue their current category 1 DMT, which includes therapies such as dimethylfumarate, glatiramer acetate, interferon beta, and teriflunomide, or switch to ofatumumab based on their physician’s clinical judgment. There is no treatment allocation by the study itself. Data collection will cover up to 24 months, and the frequency of visits and assessments will follow routine clinical practice without a fixed protocol. During the study, baseline and follow-up data will be gathered according to standard care recommendations, including clinical evaluations and sNfL measurements. Researchers will monitor the proportion of patients with high sNfL levels over time to assess disease activity. The observational period is flexible and guided by the treating physician, with no additional diagnostic or monitoring procedures beyond standard care. Participants will be followed for up to two years to better understand how sNfL influences treatment management in relapsing MS.

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

This research aims to assess how satisfied people with Multiple Sclerosis (MS) are after receiving subcutaneous (under the skin) injections of ocrelizumab over a period of 12 months. The study focuses on participants diagnosed with relapsing-remitting MS (RMS) or primary progressive MS (PPMS) according to 2017 McDonald criteria, who are starting ocrelizumab treatment for the first time. The main goal is to understand participant satisfaction using a special questionnaire designed for subcutaneous therapy administration. Participants will receive ocrelizumab as an injection under the skin, with the exact dosing and schedule determined by their treating physician following local medical guidelines. This observational study does not change standard care but monitors patients throughout their treatment with ocrelizumab. During the study, participants will complete the Therapy Administration Satisfaction Questionnaire for subcutaneous treatment after 12 months to measure their satisfaction. Researchers will also observe and record any relevant clinical information. The total study duration for each participant is 12 months, during which their experience and outcomes with ocrelizumab are carefully tracked.

Researchers are evaluating the usability and value of an integrated digital care management platform designed for people with relapsing remitting multiple sclerosis (RRMS). The study aims to improve monitoring of participants with MS in clinical practice by using the MS care management platform. This is a two-year prospective study with additional data collected at baseline to assess medical practice over at least one year before introducing the platform. The MS care management platform includes two main components: icobrain ms, a cloud-based artificial intelligence tool that analyzes brain volume and abnormalities on MRI scans to detect subclinical disease changes; and icompanion ms, which includes a free participant mobile app and website for tracking health and medications, and a web portal for healthcare professionals (HCPs) to access participant data and MRI reports. The platform integrates participant-entered data and MRI brain reports for comprehensive disease monitoring. Participants will use the icompanion ms app regularly while HCPs will access the web portal to review data. The study will collect usability scores from both participants and HCPs at baseline, 6, 12, and 24 months using standard questionnaires. In addition, HCPs will be interviewed to assess changes in their perception of disease worsening. The study includes safety monitoring and aims to evaluate the platform's value over the two-year period.