Lutherstadt Eisleben

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 conducting a prospective, observational study to describe the real-world clinical experience of patients with metastatic castration-resistant prostate cancer mCRPC treated with a combination of olaparib and abiraterone. The study aims to assess clinical outcomes in patients who are either new to novel hormonal agents NHA-naive or have been previously exposed to these agents before starting olaparib plus abiraterone treatment. Patient demographics, clinical characteristics, and treatments before and after olaparib plus abiraterone will also be documented. Participants will be observed from the start of their olaparib plus abiraterone treatment, with no investigational interventions administered by the study team, reflecting real-world treatment usage. The study plans to enroll patients for up to two years and will follow each patient for one year after the last patient begins treatment. The primary outcome measured is the time to treatment discontinuation within 12 months, along with secondary outcomes such as the time to the first subsequent therapy within 24 months. During the study, participants clinical data, treatment histories, and outcomes will be collected and analyzed. There are no specific study visits or procedures imposed beyond routine clinical care. Safety and treatment adherence will be monitored through observational data. Participants are expected to be involved for the duration of their treatment and follow-up, which may extend to approximately three years from enrollment start to last follow-up.

Researchers are evaluating treatments for adults with locally advanced or metastatic urothelial carcinoma bladder cancer who have progressed after prior therapy with enfortumab vedotin EV plus pembrolizumab. This global, multicenter, randomized, open-label Phase 23 trial compares a new drug, Datopotamab Deruxtecan Dato-DXd combined with either carboplatin or cisplatin, against the standard gemcitabine combined with carboplatin or cisplatin. The study aims to identify the recommended dose for Phase 3 and assess preliminary safety and efficacy during Part A, followed by a larger Phase 3 evaluation. Participants in Part A receive Dato-DXd at doses of 4 mgkg or 6 mgkg with platinum chemotherapy every three weeks. In Part B, participants receive the selected recommended dose of Dato-DXd or gemcitabine, each combined with either carboplatin or cisplatin, administered intravenously every three weeks. The specific platinum drug and dosing schedule are based on eligibility and investigator judgment, including options for split-dose cisplatin in certain cases. During the trial, participants undergo regular assessments including imaging scans to monitor tumor response, safety evaluations, and laboratory tests. The primary outcomes include overall response rate in Phase 2 and progression-free survival and overall survival in Phase 3, tracked up to approximately 34 to 38 months. Participants are followed throughout treatment and for a period afterward to evaluate treatment effects and safety under medical supervision.