Fulda

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 AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are investigating whether ziltivekimab can treat people living with heart failure and inflammation. The study compares ziltivekimab, a new medicine not yet approved anywhere, to a placebo, an inactive substance that looks like the medicine but contains no active drug. Participants have an equal chance of receiving either treatment. The study is expected to last up to one year and four months and focuses on people with heart failure who also have systemic inflammation. Participants will receive either ziltivekimab or placebo by monthly injections under the skin. The doses are given once a month throughout the study period. The study lasts for 12 months of treatment following randomization, during which the effects of the medicine compared to placebo will be closely monitored. During the study, participants will undergo various assessments including a heart failure questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure symptoms and physical function over the 12 months. Other evaluations may include walking tests and heart function tests. Safety and health will be monitored regularly to understand how participants respond to the treatments and to track any side effects or changes in heart failure symptoms.

Researchers are evaluating how well insulin icodec helps people with type 1 diabetes control their blood sugar levels. This study focuses on participants who have never used insulin icodec before and aims to observe their treatment experience over a period of about 22 to 30 weeks. The study is designed as a real-world, multi-center, prospective observational study to assess glycemic control, treatment satisfaction, and adherence. Participants will be treated with commercially available insulin icodec as prescribed by their doctors, following usual clinical practice. There is no randomization or placebo group; all participants receive insulin icodec. The treatment period lasts approximately 22 to 30 weeks, during which participants continue their daily basal and bolus insulin regimen prior to starting insulin icodec. During the study, participants will have their blood sugar control monitored, including measuring changes in glycated hemoglobin (HbA1c) from baseline to week 26. Researchers will also assess treatment satisfaction and adherence. Participants must provide consent and be available for study visits and data recording throughout the study duration.

Researchers are evaluating how well the approved weekly injectable insulin icodec controls blood sugar levels compared to daily injectable basal insulins in adults with type 2 diabetes. This Phase 4 study focuses on people who need to start basal insulin treatment and have had type 2 diabetes for at least 180 days. The goal is to understand the effectiveness of once-weekly insulin icodec against standard daily basal insulins in real-world clinical practice over about 13 months. Participants will receive either insulin icodec once a week or one of the daily basal insulin analogues, such as insulin glargine, insulin detemir, or insulin degludec. Both treatments are given by subcutaneous injection. The choice between weekly or daily insulin is based on current treatment standards for type 2 diabetes. The study lasts approximately 52 weeks, during which participants maintain their assigned insulin regimen. During the study, researchers will monitor changes in participants' blood sugar control using the glycated hemoglobin (HbA1c) test from the start until week 52. Participants will have their HbA1c measured within 90 days before starting the treatment. Safety and any reactions to the insulin will also be tracked. The study aims to assess how well the weekly insulin icodec works compared to daily basal insulins in managing blood sugar over a year.

Researchers are evaluating the safety and effectiveness of SAR441566 in adults with moderate to severe Crohn's Disease in this phase 2, multinational, randomized, double-blind, placebo-controlled study. The main goal is to compare different doses of SAR441566 against a placebo to see how well they work in treating Crohn's Disease. The study involves participants who have had a confirmed diagnosis of Crohn's Disease for at least three months and have shown moderate to severe symptoms. Participants will take either SAR441566 tablets or matching placebo tablets orally during the study. The study begins with a 4-week screening period, followed by a 52-week main treatment phase that includes 12 weeks of induction treatment and 40 weeks of maintenance treatment under double-blind conditions. After this, a 2-week follow-up is conducted for those not entering the long-term safety study. Eligible participants may join an open-label phase lasting up to 40 weeks, but the combined time in maintenance and open-label phases will not exceed 40 weeks. During the study, participants will undergo assessments including endoscopy to measure response at week 12. Researchers will monitor symptoms, stool frequency, and abdominal pain scores to evaluate treatment effects. Safety will be tracked throughout the study, including a follow-up after treatment ends. The total study duration for participants can be up to 59 weeks, with careful monitoring to ensure accurate evaluation of SAR441566's impact on Crohn's Disease.

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are collecting data in a registry study focused on adults with newly diagnosed or relapsed acute myeloid leukemia (AML). The study aims to gather detailed epidemiological information such as age, prognostic factors, and subgroup distributions. It also compares AML incidence and age distribution with population-based tumor registry data. Important clinical outcomes like relapse-free survival, time to relapse, cumulative incidence of relapse, and overall survival are being evaluated over a 10-year period. This study does not involve experimental treatments but instead documents current treatment strategies used in AML patients. Data collection occurs at 60 investigator sites across Germany, providing a broad overview of patient characteristics and management. There is no upper age limit, and all adult patients diagnosed according to WHO criteria, including acute promyelocytic leukemia, are eligible. Participants will be followed for up to 10 years, during which epidemiological parameters and survival outcomes will be monitored. Researchers will record relapse events, time until relapse, and survival status to understand long-term outcomes. This extensive follow-up intends to support improved knowledge about AML patient prognoses and treatment impacts over time.

Researchers are studying whether performing percutaneous coronary intervention (PCI) on all significant blocked arteries (multivessel complete PCI) is better than treating only the artery causing the current heart attack (culprit-lesion only PCI) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) who have blockages in multiple heart arteries. This trial is designed as a prospective, randomized, controlled, and open-label study conducted at multiple centers to compare these two treatment approaches for people with NSTEMI and multivessel coronary artery disease. Participants will be assigned to one of two groups: one receiving PCI only on the artery responsible for the heart attack (culprit-lesion revascularization), and the other receiving PCI on all significant blockages in the heart arteries (complete PCI). The procedures involve opening blocked arteries using standard catheter-based techniques. The study will monitor participants over an estimated average of two years to evaluate outcomes. During the study, researchers will track the combined rate of cardiovascular death or rehospitalization for a new heart attack as the primary outcome. Participants will be followed closely for up to two years, with regular assessments and medical monitoring to capture these events. This approach aims to determine which PCI strategy leads to better long-term heart health and fewer complications.