Schwetzingen

Researchers are evaluating various approved injectable and oral disease-modifying treatments (DMTs) in patients with relapsing multiple sclerosis (RMS) in Germany. This observational, non-interventional, multicenter, open-label study collects primary data prospectively over up to four years, alongside retrospective data. The study captures medical history, disease duration, laboratory values, disability scores (EDSS), MRI results, and relapse information to provide real-world insights into treatment use and outcomes. Patients receiving routine medical treatment with any approved injectable or selected oral DMTs—including ofatumumab, glatiramer acetate, interferon 21, teriflunomide, dimethyl fumarate, and diroximel fumarate—are enrolled without treatment allocation by the study. Two cohorts are observed: one treated primarily with injectable DMTs and another with injectable or oral DMTs. The core study period lasts about two years, with an optional extension providing an additional two years of observation, totaling up to four years. Follow-up visits and monitoring happen at the investigator's discretion and may include telemedicine. During the study, participants provide data through questionnaires and electronic case report forms. Routine clinical care procedures, such as diagnostic tests and monitoring, continue as usual. Researchers measure the proportion of patients continuing their baseline treatment at 24 months and collect ongoing clinical and imaging data. The study emphasizes real-world treatment patterns, safety, and disease activity over the extended follow-up period.

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.

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.

Immune thrombocytopenia (ITP) is a rare blood disorder where the immune system causes a shortage of platelets, leading to increased bleeding risk. New treatment options have emerged recently, but clinical studies often focus on specific patient groups. This research collects real-world data from a broad range of ITP patients to better understand the diagnosis, treatment, and outcomes in everyday care. The study also aims to improve personalized therapy and patient results by gathering detailed clinical and biospecimen information. The study involves creating a national registry where clinical data and biospecimens are collected from patients diagnosed with primary or secondary ITP. Data are gathered prospectively at defined points during the disease course, and patients can also be included retrospectively within 12 months of diagnosis if ongoing documentation is available. This includes information about disease factors, treatment types, complications, quality of life, fatigue, and survival over 5 years. Participants will provide written consent and undergo clinical assessments at enrollment and follow-up visits. Researchers will collect epidemiological data such as disease incidence, age and sex distribution, causes, treatment types, and remission status over 5 years. The registry also includes biospecimen collection to support high-quality, standardized research. This ongoing monitoring will help improve knowledge of ITP and support better patient care.

Researchers are studying the use of venetoclax in people with chronic lymphocytic leukemia (CLL) to understand how effective it is and to assess the costs and patient-reported outcomes when used in real-life medical settings. The study looks at venetoclax given alone or combined with rituximab, obinutuzumab, ibrutinib, or acalabrutinib, based on doctors' decisions and local treatment guidelines. Participants receive venetoclax therapy as prescribed by their physician, which may include the drug alone or along with one of the mentioned combination treatments. The study follows patients in Austria, Germany, and Switzerland, observing how the treatments are used in everyday practice without altering the prescribed therapy. During the study, participants are monitored for up to 12 months to measure the percentage who achieve the best overall response rate (ORR) to treatment. Researchers also collect data on health economics and patient experiences to better understand the impact of these therapies in routine care.