Itzehoe

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 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.

Researchers are evaluating asthma control, health-related quality of life (HRQL), lung function, and asthma medication use in patients with severe eosinophilic asthma treated with benralizumab in a real-life clinical setting in Germany. This prospective, non-interventional, single-arm, multicenter study aims to observe these outcomes over a 52-week period to better understand benralizumab's impact outside of randomized clinical trials. Patients prescribed benralizumab according to label and local reimbursement criteria will be followed for up to 52 weeks. The study will monitor asthma control using the Asthma Control Test (ACT) and the Asthma Impairment and Risk Questionnaire (AIRQ®) at various timepoints. Health-related quality of life will be assessed with the mini Asthma Quality of Life Questionnaire (miniAQLQ) at baseline and routine follow-up visits. Patients will also track and report their weekly asthma medication intake using either paper-based or electronic diaries throughout the study. Participants will complete questionnaires every 4 weeks and record medication intake weekly. Researchers will measure changes in ACT scores, proportions of responders, and reductions in inhaled corticosteroid doses from baseline to weeks 12, 24, and 52. Safety and health outcomes will be observed under routine clinical care. This study includes adults aged 18 to 120 years with severe eosinophilic asthma who can understand study instructions and provide informed consent.

Researchers are evaluating the effectiveness and safety of remibrutinib in adults aged 18 to 65 years with secondary progressive multiple sclerosis (SPMS). This Phase III study is randomized, double-blind, and placebo-controlled, designed to better understand how remibrutinib affects disability progression in SPMS patients over time. Participants will be randomly assigned to receive either oral remibrutinib tablets or matching placebo tablets during the Core Part of the study, which is event-driven and double-blinded. After this period, all participants may enter an Extension Part where they receive open-label remibrutinib treatment. This design allows researchers to compare remibrutinib against placebo and then monitor long-term effects when all participants receive the active drug. Throughout the study, participants will undergo regular assessments including MRI scans and clinical evaluations to track changes in disability using the Expanded Disability Status Scale (EDSS). The primary outcome measured is the time to confirmed disability progression over six months, with follow-up lasting up to approximately five years. Safety, tolerability, and other health parameters will also be closely monitored during both study phases.

Researchers are collecting new real-world data on first-line treatment for women newly diagnosed with advanced high-grade epithelial ovarian cancer in Germany. This study aims to understand how maintenance treatment with Poly ADP ribose polymerase inhibitors (PARPi) affects routine medical care, patient outcomes, and treatment sequences, especially in those undergoing surgery and chemotherapy. It also explores patient-reported experiences, physician insights, genetic testing practices, and drug safety in this setting. The study observes patients receiving first-line platinum-based chemotherapy, including those who have completed primary debulking surgery. It includes patients who have started or are planning to start chemotherapy, with the total number of chemotherapy cycles tailored by the treating physician. Women of childbearing potential must use reliable contraception during the study. The study does not involve any experimental interventions but monitors treatments as they occur in regular clinical practice. Participants will be followed to evaluate progression-free survival and other outcomes up to 84 months from the start of chemotherapy. Patient-reported outcomes will be collected electronically to capture experiences and needs during and after maintenance therapy. The study also tracks the use of BRCA/HRD testing, treatment safety, and physician experiences to better understand care patterns and long-term results in routine clinical settings.

Researchers are conducting an international, prospective, multicenter, non-randomized observational study to assess the safety and performance of the MOVEC cervical disc prosthesis. The study also aims to understand how patients' quality of life changes after receiving the MOVEC implant and to analyze the range of motion, which is important for implants that preserve movement. The study focuses on adults diagnosed with discopathy, herniated cervical discs, spinal stenoses, or radiculopathy who have experienced neck and upper extremity pain or neurological deficits related to these conditions. Participants will receive either mono- or bisegmental implantation of the MOVEC cervical prosthesis. This device is designed to treat cervical intervertebral disc problems while maintaining motion in the spine. The study does not randomize participants but observes outcomes after the implantation. There are no additional treatment groups; all participants receive the MOVEC prosthesis. During the study, participants will be evaluated at baseline and again at 24 months after implantation. Researchers will measure improvements using the Neck Disability Index and Visual Analogue Scales for arm and neck pain. Data collection includes clinical and radiological assessments to monitor safety, performance, quality of life, and range of motion. Participants are expected to fully engage in the study and provide informed consent, with assessments continuing through the two-year follow-up period.

Researchers are evaluating the long-term effects of Dupilumab treatment on patients with Chronic Obstructive Pulmonary Disease (COPD) in a real-world setting over 24 months. The study focuses on changes in health-related quality of life, patient characteristics, effectiveness, and safety of Dupilumab for those whose COPD remains uncontrolled despite standard therapies and who have elevated blood eosinophils. This is a non-interventional study where patients receive Dupilumab as prescribed by their doctors according to approved guidelines, without any treatment administered by the study itself. Dupilumab treatment initiation happens independently from study recruitment, and patient data is collected during routine clinical care. Participants will be involved for up to 12 months with assessments including monitoring changes in the COPD Assessment Test (CAT) score from baseline. Data is gathered through clinical evaluations and patient-reported outcomes. Safety and effectiveness are observed through regular documentation of clinical health and patient experiences during their ongoing treatment.

Researchers are conducting the CATALINA study, a prospective cohort research project within the CICERO collaboration, to gather standardized clinical data and biological samples from patients hospitalized due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). The aim is to collect detailed information and samples from 1000 patients over a three-year period to better understand COPD exacerbations and support future European-wide clinical trials and prognostic tool development. Data and samples will be collected during six planned visits: three during the hospital stay (within 48 hours of admission, at 72 hours after inclusion, and at hospital discharge) and three during outpatient follow-up (at 3, 6, and 12 months after inclusion). If a participant is readmitted for respiratory reasons during the study, three additional unscheduled visits with similar timing as the initial hospitalization visits will occur. The study will continue to expand its data and biobank over future cycles. Participants will undergo evaluations at each visit, including clinical assessments and biological sample collection. Researchers will monitor all-cause mortality over one year as the primary outcome. The study involves close follow-up during hospitalization and outpatient visits to gather comprehensive data on COPD exacerbations and patient outcomes over a full year.