Itzehoe

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 evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are conducting a prospective observational study to examine asthma control, health-related quality of life HRQL, lung function, and asthma medication use in patients with severe eosinophilic asthma treated with benralizumab in routine clinical practice settings in Germany. The study aims to gather real-world evidence on these patients over a 52-week period. Participants will be treated with benralizumab as part of their standard care, and no additional treatment will be assigned by the study. Asthma control will be assessed using the Asthma Control Test ACT and the Asthma Impairment and Risk Questionnaire AIRQae at various timepoints. Health-related quality of life will be measured using the mini Asthma Quality of Life Questionnaire miniAQLQ at baseline and follow-up visits. Patients will record their weekly asthma medication intake using either paper or electronic diaries throughout the study. During the study, participants will attend routine follow-up visits where investigators will collect clinical assessments and questionnaire data. Researchers will monitor changes in asthma control, lung function parameters, medication use, and patient-reported outcomes up to 52 weeks after the first dose of benralizumab. The primary outcomes include changes in ACT scores and inhaled corticosteroid use, while secondary outcomes cover remission criteria, lung function, biomarkers, exacerbation rates, and quality of life measures.

Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.

Researchers are conducting an international, prospective, multicenter, non-randomized observational study to confirm the safety and performance of the cervical disc prosthesis MOVE4-C. The study also aims to understand how patients quality of life changes after implantation and to assess the range of motion, which is important for implants that preserve movement. This research focuses on individuals with discopathy, herniated cervical discs, spinal stenoses, or radiculopathy. The study involves a single group of 170 patients who will receive a mono- or bisegmental implantation of the MOVE4-C cervical prosthesis. This device-based intervention is observed without randomization or a comparison group. The research collects clinical and radiological data to evaluate the devices performance over time. There are no placebo or blinded treatments involved. Participants will be followed up from baseline through 24 months after implantation. Researchers will assess improvements in neck disability, arm and neck pain using the Neck Disability Index and Visual Analogue Scales, as well as other health and function measures like the Core Outcome Measure Index, SF-36, EuroQoL, and Japanese Orthopedic Association Score. Range of motion and any adverse events related to the device will be monitored. The study includes clinical visits and evaluations to collect these outcomes and ensure safety throughout the follow-up period.

Researchers are evaluating how Dupilumab affects health-related quality of life, patient characteristics, efficacy, and safety in adults with Chronic Obstructive Pulmonary Disease COPD in a real-world setting over 24 months. This non-interventional study observes patients who have started Dupilumab treatment independently of the study, focusing on those with uncontrolled COPD despite standard inhaled therapies and elevated blood eosinophils. Patients receive Dupilumab as prescribed in routine clinical practice, with no treatment assigned by the study itself. The study collects data over two years, documenting changes in COPD symptoms, lung function, exacerbation rates, and safety outcomes as patients continue their usual care. During the study, participants clinical data, including COPD Assessment Test CAT scores, lung function tests, exacerbation frequency, and adverse events, are monitored at regular intervals up to 24 months. Patient-reported outcomes and other health measures are collected to understand Dupilumabs long-term effects in everyday use. The study also gathers information on hospitalizations, workdays missed, and reasons for treatment initiation.

Researchers are conducting the CATALINA study, a prospective cohort study within the CICERO collaboration, to collect standardized clinical data and biological samples from patients hospitalized for an acute exacerbation of Chronic Obstructive Pulmonary Disease COPD across 20 centers in Europe and beyond. The goal is to develop a detailed European COPD patient data and biobank to support future clinical trials and improve tools for predicting COPD exacerbations. The study plans to recruit 1000 patients hospitalized for an acute COPD exacerbation and follow them for one year. Data and samples will be collected during six scheduled visits three during hospitalization within 48 hours of admission, at 72 hours, and at discharge and three outpatient visits at 3, 6, and 12 months after inclusion. In case of a first respiratory-related hospital readmission during the study, three additional unscheduled visits will follow the same testing schedule as the initial hospitalization. Participants will undergo clinical assessments, biological sampling, and monitoring at each visit, including evaluations of mortality, hospital care needs, treatment responses, respiratory health scales, mental health questionnaires, comorbidities, and various biomarkers. The study will track these outcomes for one year and aims to expand the data and biobank in future CICERO lifecycles, supporting long-term research efforts in COPD.