Altenburg

Researchers are evaluating the persistence of two treatments, upadacitinib UPA and tumor necrosis factor inhibitors TNFi, in adults with moderate to severe active rheumatoid arthritis RA. This observational study is conducted in Germany with about 678 participants across roughly 80 sites. The purpose is to compare how long participants continue their prescribed treatment under real-world conditions over time. Participants will receive either UPA or TNFi treatment as prescribed by their doctors, following local labels and standard care practices. Treatment decisions were made before joining the study and are independent of recruitment. The study will observe participants for up to 24 months to assess retention rates on these treatments. During the study, participants will be monitored regularly according to local care standards. Researchers will collect data on how long participants stay on their assigned treatment, focusing on retention rates over approximately 24 months. Study participation may last up to two years, with recruitment expected to take about 24 months, resulting in a total study duration of about 48 months.

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.

This research aims to observe the long-term safety of efgartigimod treatment in adults with generalized myasthenia gravis gMG. It compares patients who are starting or have recently started efgartigimod treatment with those who have not been exposed to efgartigimod and are receiving other standard treatments. The study is non-interventional and prospective, focusing on real-world safety outcomes over an extended period. Participants are divided into two groups one receiving efgartigimod and another receiving other medications for myasthenia gravis. This study does not involve any new treatments being administered as part of the trial but monitors patients during their routine care. The study will continue for up to 10 years to gather long-term safety data. During the study, researchers will track the occurrence of serious infections and other safety concerns in both groups. Patients will be monitored through their regular clinical visits without additional interventions from the study. Participants may be followed for up to 10 years to assess safety outcomes associated with their treatments in everyday medical practice.

This research aims to evaluate the safety and tolerability of NSC001, an experimental drug, in people aged 50 to 85 years with mild to moderate Alzheimers disease. NSC001 is designed to target specific brain receptors to potentially improve cognitive and behavioral functions. The study is a randomized, double-blind, placebo-controlled trial conducted across multiple centers to explore both safety and effects on cognition and behavior. Participants will be randomly assigned to one of three groups receiving 40 mg of NSC001 daily, 40 mg of NSC001 daily combined with 20 mg of Trospium, or a placebo with or without 20 mg of Trospium. Treatment and monitoring will occur over 16 weeks, with assessments of drug levels in the blood at specific times. The study includes careful safety monitoring and evaluation of cognitive function throughout the trial. During the study, participants and their caregivers will attend scheduled visits for physical, cognitive, and behavioral assessments. Brain imaging such as MRI or CT scans will be reviewed if available, and tests to confirm Alzheimers diagnosis will be done. Researchers will track medication adherence, collect blood samples, and monitor safety and tolerability. The primary outcomes focus on safety at the start and end of treatment, while secondary measures analyze how the drug behaves in the body over time.

Psoriatic arthritis PsA is a type of arthritis that causes joint swelling and stiffness, often occurring in people with the skin condition psoriasis. This study aims to understand how long patients continue treatment and how effective risankizumab RZB is compared to other advanced treatments for PsA in everyday clinical settings. The study will take place outside the United States across about 15 countries, involving between 900 and 1200 adult participants. Participants will receive either risankizumab or other biologic disease-modifying antirheumatic drugs bDMARDs as prescribed by their doctors following local guidelines. Treatments will be given as part of regular medical care without additional interventions from the study. Participants will be followed and observed for 24 months during their routine clinical visits. During the study, participants will attend their usual medical appointments where doctors will monitor their treatment persistence and response. The main outcome measured is how many participants continue their prescribed treatment up to 24 months. There is no expected extra burden or additional procedures for participants beyond their standard care.

Researchers are investigating sovateltide as a new treatment for acute cerebral ischemic stroke, a condition caused by a blockage in blood flow to the brain leading to tissue damage. This trial follows promising results from earlier studies in animals and humans showing sovateltides potential to improve neurological outcomes. The goal is to evaluate the safety and effectiveness of sovateltide combined with standard care for stroke patients in the United States and other countries. Participants will receive either sovateltide or normal saline as a placebo, both given as intravenous bolus doses within 24 hours of stroke onset. Three doses are administered on day 1, then repeated on days 3 and 6. The study is randomized, double-blind, and placebo-controlled, ensuring unbiased comparison between the treatment and control groups. During the study, patients will be monitored for neurological function and recovery using scales like the modified Rankin Scale, NIH Stroke Scale, and Barthel Index up to 90 days after treatment. Additional assessments include quality of life questionnaires, cognitive tests, and imaging to detect any complications. Safety is closely tracked throughout the study, which lasts about three months from treatment to final evaluation.

Researchers are collecting data in a registry study for adults diagnosed with acute myeloid leukemia AML, including newly diagnosed and relapsed cases. The study aims to gather important information about the diseases epidemiology, such as patient age and prognostic factors, and to compare incidence and age distribution with population tumor registry data. It also evaluates key clinical outcomes like relapse-free survival, time to relapse, cumulative incidence of relapse, and overall survival. This observational study does not involve treatment assignment but documents treatment strategies used by patients. Data is gathered over a 10-year period to thoroughly monitor outcomes and disease patterns. The registry also collects information on complete remission rates, treatment-related mortality, therapy-associated morbidity, and quality of therapy and diagnosis. Additionally, the study seeks to validate known prognostic factors and explore new ones while describing new therapies and supportive care measures. Participants are adults aged 18 years and older diagnosed with AML according to WHO criteria, including acute promyelocytic leukemia. The study involves long-term follow-up with yearly assessments over 10 years. Researchers will evaluate epidemiological parameters and important survival outcomes. Since this is an observational registry, participants continue with their usual care while data is collected. The study is sponsored by Technische Universitt Dresden and involves multiple sites in Germany.

This research aims to gather detailed data and biomaterials from adults diagnosed with Acute Lymphoblastic Leukemia ALL and related diseases, including certain types of Leukemia and Non-Hodgkins Lymphoma. The registry supports ALL research and quality assurance by collecting information regardless of whether patients participate in clinical trials. The study is observational and involves adults diagnosed and treated under ALL protocols. Participants include adults aged 18 and older with ALL subtypes, other leukemias treated according to ALL protocols, and specific subtypes of Non-Hodgkins Lymphoma treated under B-ALL protocols. The study collects data prospectively on diagnosis, treatment, and outcomes, along with biomaterials related to these conditions. Participants provide information during routine clinical care and follow-up visits for up to 10 years. Data collected includes survival rates, remission status assessed by various methods including PET scans, relapse rates, quality of life questionnaires, and monitoring of toxicities and comorbidities. The study tracks overall survival and other outcomes over long-term follow-up to support research and quality assurance in adult ALL and related diseases.

Immune thrombocytopenia ITP is a rare blood disorder caused by an autoimmune condition that reduces platelet counts, increasing the risk of bleeding or prolonged bleeding. New treatments for ITP have emerged recently, but existing clinical studies are limited in their applicability to everyday patient care due to strict criteria. This registry aims to collect real-world clinical data and biospecimens from patients with various types of ITP to improve understanding of diagnosis, therapy, and patient outcomes in routine treatment. The registry includes patients diagnosed with primary or secondary ITP who consent to participate. Data collection occurs at defined points in the disease course either prospectively or retrospectively up to 12 months after diagnosis, provided continuous documentation is available. Biospecimens are collected and stored systematically to support research. Clinical information collected includes disease characteristics, treatment types, complications, quality of life, fatigue scores, and survival data over a follow-up period of up to 5 years. Participants provide clinical data and biosamples at enrollment, then again at 6 months and annually for up to 5 years. Assessments include platelet counts, bleeding and thromboembolic events, laboratory markers such as specific antibodies, and patient-reported outcomes like quality of life and fatigue. The study gathers epidemiological data on incidence, age, sex distribution, causes of ITP, treatment received, and remission status. The registry helps advance knowledge about ITP through long-term monitoring and standardized data collection.

Researchers are evaluating the real-world clinical outcomes and patient-reported experiences of adults with systemic lupus erythematosus SLE who start treatment with subcutaneous anifrolumab. This prospective, single-arm, multicenter, non-interventional study focuses on patients who have not previously used anifrolumab subcutaneously or intravenously. The study aims to describe disease activity, including remission and lupus low disease activity states, quality of life, medication patterns, flares, and organ damage over time. Participants will receive subcutaneous anifrolumab as part of their routine care, with treatment decisions made independently of the study. The study follows patients for 24 months to capture long-term disease control, medication use, and organ damage progression. Data collected include clinical assessments and patient-reported outcomes in a real-life setting without altering usual treatment. During the 24-month observation period, participants will be evaluated at routine visits where disease activity, treatment patterns, quality of life, fatigue, flares, and organ damage are measured. Researchers will review outcomes such as remission rates, time to remission, and sustained disease control. Patient questionnaires and clinical assessments will help track these measures, providing insights into long-term disease management and treatment effects in everyday practice.