Hoxter

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 gathering real-world information on the use of the da Vinci Surgical Systems for treating gynecological disorders within the German healthcare system. This prospective, non-interventional, multi-center clinical study aims to evaluate robotic-assisted surgery compared to non-da Vinci surgery for gynecological procedures. The study focuses on understanding surgical outcomes and patient experiences in routine clinical practice. Participants will undergo gynecological surgeries either with robotic assistance using the da Vinci system or with other surgical methods. No experimental treatments are assigned, as this is an observational study monitoring current surgical practices. The study collects data on procedures performed with or without the da Vinci system across multiple centers. During the study, researchers will monitor the number of surgery-related complications up to 30 days post-operation, assess patient-reported outcomes for up to 12 months, and record treatment decisions as reported by the treating physicians within 30 days. Participants will be followed over these time frames to evaluate safety and treatment experiences, with total involvement depending on the timing of their surgery and follow-up assessments.

Researchers are evaluating two medications, prednisolone and colchicine, for treating acute gout attacks, a common rheumatic disease where urate crystals cause severe joint pain. This study focuses on patients treated in general practice, including those with common health conditions often excluded in past research. The goal is to determine if prednisolone is comparable or only slightly less effective than colchicine in reducing pain during gout attacks. This phase 4 trial is conducted as a double-blind, randomized, controlled study across multiple university sites in Germany. Participants will be randomly assigned to receive either prednisolone or colchicine tablets for five days, with both groups also receiving placebo tablets to maintain blinding. The study uses the double-dummy method to ensure neither patients nor doctors know which treatment is given. Additionally, participants have the option to undergo a dual-energy CT scan of their feet to detect urate crystal deposits, which may provide insights into disease burden. During the study, patients will visit their general practitioner twice: once at the start and again after about one week. They will complete daily diaries tracking pain, joint swelling, tenderness, and any additional pain medication use for six days. Blood tests will check uric acid levels, inflammation, and kidney function. After four weeks, participants will be contacted by phone to assess recovery, recurrence, treatment, work incapacity, and side effects. The main measurement is the highest pain level reported on day 3 after starting treatment.