Lutherstadt Eisleben

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.

Researchers are evaluating the real-world clinical use and outcomes of men with metastatic castration-resistant prostate cancer (mCRPC) who are treated with a combination of olaparib and abiraterone. The study focuses on patients who have either not previously received next-generation hormonal agents (NHA-naive) or who have been exposed to NHAs before starting this combined treatment. This prospective observational study aims to describe patient demographics, clinical characteristics, and treatments before and after olaparib plus abiraterone therapy. The study will enroll patients who have started treatment with olaparib plus abiraterone after the study site became active. It will follow patients for up to 2 years to collect data on their treatment experience. No experimental interventions are administered as part of the study; instead, it observes patients receiving standard treatment in routine clinical settings. Participants will be monitored from the start of olaparib treatment until one year after the last patient enrolls. Researchers will collect clinical data to assess treatment discontinuation times and overall outcomes during this period. The study will capture information on patients’ clinical progress and any subsequent therapies, providing insights into the real-world effectiveness and use of this treatment combination.

Researchers are conducting a global, multicenter, randomized, open-label Phase 2/3 trial to study the effects of Datopotamab Deruxtecan (Dato-DXd) combined with carboplatin or cisplatin versus gemcitabine combined with carboplatin or cisplatin. This study focuses on participants with locally advanced or metastatic urothelial carcinoma (la/mUC) who have experienced disease progression during or after treatment with enfortumab vedotin (EV) plus pembrolizumab. The research aims to assess preliminary efficacy, safety, and tolerability, and to identify the recommended Phase 3 dose (RP3D) based on Phase 2 results before proceeding to the Phase 3 portion. Dato-DXd will be given as an intravenous infusion every three weeks at a dose of 4 mg/kg or 6 mg/kg during Phase 2 or the RP3D during Phase 3. Carboplatin and cisplatin will also be administered intravenously every three weeks, with carboplatin dosed at AUC 4.5 or 5.0 mg·min/mL and cisplatin at 70 mg/m2. Gemcitabine will be given intravenously at 1000 mg/m2 on Days 1 and 8 of each three-week cycle. Participants eligible for cisplatin will receive it; those ineligible will receive carboplatin. The study starts with Phase 2 (Part A) to assess early outcomes and safety, then moves to Phase 3 (Part B) depending on those findings. Participants will be monitored for overall response rate, progression-free survival, and overall survival over periods up to 34 months in Phase 2 and 38 months in Phase 3. Assessments include radiographic evaluations to document disease progression or death. Safety and treatment tolerability will be closely observed throughout. Participants will provide tumor tissue samples for biomarker testing, and dosing will be tailored based on eligibility and investigator judgment. This comprehensive monitoring aims to evaluate the treatments' impact and patient outcomes over the study duration.