Zwickau

Researchers are evaluating the retention rates of two treatments, Upadacitinib (UPA) and tumor necrosis factor inhibitors (TNFi), in adults with moderate to severe active rheumatoid arthritis (RA). The study is observational, conducted in Germany, and aims to compare how long patients stay on each treatment under real-world conditions according to local labels and standard care. About 678 participants will be enrolled across approximately 80 sites in Germany. Participants will have been prescribed UPA or TNFi independently of the study, following approved labels and local regulations. The study will observe participants receiving either UPA or TNFi therapy over a period of up to 24 months. Participants will be followed for up to 24 months to assess treatment retention. Researchers will monitor how long participants remain on their prescribed treatment and collect related clinical data. The total study duration, including recruitment and follow-up, is expected to last about 48 months.

Researchers are evaluating the effectiveness, safety, and patient-reported outcomes of standard treatments for people with relapsed or refractory multiple myeloma in real-world clinical settings. This study follows participants over 24 months to observe how current standard care works for those who have previously received treatment for this condition. The research includes participants who meet specific diagnostic criteria and have measurable disease based on recognized myeloma guidelines. The study does not involve any experimental treatment; instead, it observes patients receiving standard care as decided by their doctors. Participants include those who have undergone multiple prior therapies, including specific drug classes and targeted treatments, depending on the study period. The study covers different periods with slightly varied eligibility and treatment histories, including a group starting talquetamab treatment for relapsed or refractory multiple myeloma. Participants will be monitored for up to 52 months to evaluate their response to treatment, including overall response rates. Researchers will collect data on their health status, treatment history, and patient-reported outcomes. Safety and effectiveness will be assessed based on clinical evaluations and disease progression as determined by their healthcare providers throughout the study period.

Axial spondyloarthritis (axSpA) is an immune-related inflammatory disease mainly affecting the spine, causing chronic back pain and significantly impacting quality of life with symptoms like sleep problems, social isolation, and emotional distress. This research is evaluating the real-world effectiveness of the drug upadacitinib in controlling disease activity and managing pain in adults with active axSpA in Germany. Participants will receive oral upadacitinib tablets as prescribed by their doctors before joining the study, following local guidelines on dosage and treatment. The study will last about 52 weeks, during which participants will continue their prescribed treatment and attend regular medical visits as part of routine care. Throughout the study, researchers will monitor disease activity and treatment effects using medical assessments, side effect checks, and questionnaires. The main focus is on how many participants achieve and maintain low disease activity scores over 24 and 52 weeks, assessing both clinical and patient-reported outcomes related to pain and disease burden.

This research aims to assess how satisfied people with Multiple Sclerosis (MS) are after receiving subcutaneous (under the skin) injections of ocrelizumab over a period of 12 months. The study focuses on participants diagnosed with relapsing-remitting MS (RMS) or primary progressive MS (PPMS) according to 2017 McDonald criteria, who are starting ocrelizumab treatment for the first time. The main goal is to understand participant satisfaction using a special questionnaire designed for subcutaneous therapy administration. Participants will receive ocrelizumab as an injection under the skin, with the exact dosing and schedule determined by their treating physician following local medical guidelines. This observational study does not change standard care but monitors patients throughout their treatment with ocrelizumab. During the study, participants will complete the Therapy Administration Satisfaction Questionnaire for subcutaneous treatment after 12 months to measure their satisfaction. Researchers will also observe and record any relevant clinical information. The total study duration for each participant is 12 months, during which their experience and outcomes with ocrelizumab are carefully tracked.

Researchers are investigating the real-world use, effectiveness, quality of life impact, safety, and tolerability of the combination of encorafenib and binimetinib in patients with unresectable advanced or metastatic melanoma that has a specific BRAF V600 mutation. This prospective, longitudinal, non-interventional study focuses on patients in Germany, Austria, and Switzerland who receive these drugs after they became commercially available. The study includes patients receiving first or second line treatment, particularly after prior checkpoint inhibitor therapy. The study observes patients treated with encorafenib plus binimetinib according to approved prescribing guidelines (Summary of Product Characteristics). Patients may have started treatment within six months before joining the study or plan to start soon. No experimental interventions are given; instead, the study collects real-life treatment data under routine clinical care in multiple centers across the three countries. Participants will be followed to gather information on progression-free survival at 12 months after starting treatment. Data collected include safety, tolerability, quality of life, and treatment patterns. The study documents patient outcomes and treatment experiences in a naturalistic setting without altering standard care. Participation duration depends on treatment and follow-up schedules determined by routine clinical practice and study timelines.

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.

Atrial fibrillation is a common heart rhythm disorder that increases the risk of blood clots forming in the heart, especially the left atrium. These clots can cause strokes if they travel to the brain. Patients with atrial fibrillation who have previously experienced bleeding in the brain (intracranial bleeding) face challenges in treatment, as blood thinners can prevent clots but also increase bleeding risk. This research compares two approved treatment methods for such patients: a device to close the left atrial appendage (LAA) and oral blood-thinning medications (anticoagulants). One group of patients will receive a procedure to close the LAA using a device called Watchman or Watchman FLX, performed by skilled doctors under imaging guidance. After this procedure, patients usually take aspirin and clopidogrel for three months, followed by aspirin alone for up to a year. Alternatively, some may receive three months of oral anticoagulants followed by aspirin. The other group will continue oral anticoagulation therapy with medications that reduce stroke risk but have bleeding considerations. The study uses only approved devices and medications. Participants will be monitored for up to three years to track events such as cardiovascular death, stroke, embolism, and bleeding complications. Researchers will assess these outcomes to understand the benefits and risks of each treatment. The study aims to provide important data to guide doctors in managing atrial fibrillation patients with prior brain bleeding and to help reduce mortality and complications in this high-risk group.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are collecting detailed information on adults diagnosed with Acute Lymphoblastic Leukemia (ALL) and related blood cancers such as other leukemias and certain types of Non-Hodgkin's Lymphoma. The purpose is to gather real-world data on diagnosis, treatments, and outcomes to support ALL research and improve quality of care. This registry includes patients whether or not they are part of other clinical trials. Participants included in this registry are adults aged 18 and older diagnosed with ALL or similar leukemias who are treated according to established ALL treatment protocols. It also includes patients with specific subtypes of Non-Hodgkin's Lymphoma treated according to B-ALL protocols. The study involves collecting clinical data and biological samples over time to understand treatment responses and disease progression. Throughout the study, researchers will monitor participants' health outcomes, including overall survival for up to 10 years. Data collected will cover diagnostics, treatments received, and patient outcomes in routine clinical care. This long-term follow-up aims to provide valuable insights into the effectiveness of current therapies and patient experiences with these blood cancers.

Researchers are evaluating treatments for adults with relapsed or refractory Acute Myeloid Leukemia (AML) in this randomized, open-label clinical trial. The study compares the effects of low-intensity therapies versus high-intensity reinduction chemotherapy in patients experiencing their first or second relapse. Funded by the European Commission, the trial aims to determine whether low-intensity treatments provide similar clinical benefits as high-intensity chemotherapy over a 36-month period. Participants will receive either high-intensity chemotherapy regimens, such as combinations including Cytarabine, Mitoxantrone, or Fludarabine, or low-intensity therapies like Venetoclax with hypomethylating agents, Gilteritinib, or other targeted drug combinations. Both treatment options will be selected based on local availability and clinical suitability. The study follows a pragmatic approach, focusing on real-world treatment settings and personalized options for each patient. Throughout the trial, researchers will monitor patient outcomes, including event-free survival over three years. Assessments will include clinical evaluations, treatment adherence, and safety monitoring. Patients must be able to provide informed consent and will be followed closely to compare the effectiveness and tolerability of the different therapy intensities in managing relapsed or refractory AML.