Augsburg

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.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are evaluating the long-term safety and effectiveness of APG777 in adults with moderate-to-severe atopic dermatitis who have completed treatment in a previous APG777 study. This phase 2 extension study involves participants who, according to their doctors, would benefit from continued treatment with APG777. The study is designed as a multicenter, double-blind trial to assess ongoing treatment outcomes and safety over several years. Participants in this study will continue receiving APG777 through three main periods a screening visit coinciding with the last visit of the prior studys maintenance period, an extended treatment period, and a post-treatment follow-up period. Participants who met certain skin improvement criteria and did not use topical rescue medication during the prior study will maintain their previous dose and injection frequency. Those who did not meet these criteria or used rescue medication will receive APG777 according to a specific dosing plan in an open-label escape arm. During the study, participants will be closely monitored for treatment-emergent adverse events up to 3 years. The research team will also measure skin improvements using tools such as the Eczema Area and Severity Index EASI and the Investigator Global Assessment for Atopic Dermatitis vIGA-AD, as well as tracking itch severity, use of rescue therapy, and serum drug concentrations. The overall participation time includes up to 3 years of follow-up to evaluate long-term safety and efficacy outcomes.

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 assessing the effectiveness and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GEJ adenocarcinoma whose tumors express PD-L1 CPS 1. The study also evaluates rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, global, multicenter trial sponsored by AstraZeneca. Participants are divided into three groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy either 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Treatments are given by intravenous infusion every three weeks or oral administration twice daily for capecitabine. This setup allows comparison of different combinations to evaluate each drugs role. During the study, participants will be monitored for progression-free survival and overall survival up to about six years. Researchers will also assess response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and quality-of-life factors like eating difficulties and side-effect burden. The study involves regular assessments including tumor measurements and laboratory tests. Participation may last several years, with safety and efficacy closely followed throughout this time.

This research aims to evaluate disease status in children newly diagnosed with high-grade glioma that have a TRK fusion. It is a pilot study focusing on children up to 21 years old, assessing disease control and survival rates. The study also examines the safety of larotrectinib given with chemotherapy or after focal radiation therapy in this group. Participants will receive larotrectinib orally twice daily at a dose based on body surface area, in 28-day cycles. After 2 cycles of larotrectinib alone, patients showing a complete or continued complete response will continue larotrectinib as maintenance therapy for up to 12 cycles, with possible extension to 24 cycles if beneficial. Those with partial response or stable disease may receive additional chemotherapy or focal radiation depending on age and clinical factors. A surgical cohort will receive larotrectinib for 3-5 days before surgery followed by larotrectinib treatment. During the study, participants will be closely monitored for disease control using imaging and for safety by tracking side effects and adverse events. Researchers will measure drug levels in blood and tumor tissue in the surgical group. The main outcomes include disease control after 2 cycles and treatment-related side effects, with survival rates assessed over time. Participation involves regular visits, treatment cycles, and follow-up evaluations for up to several years.

Researchers are evaluating the use of fluciclovine 18F PETCT scans to detect recurrent prostate cancer in male patients whose earlier PSMA PETCT scans were negative or inconclusive. This observational study takes place at two specialized nuclear medicine centers in Germany and focuses on patients with biochemical recurrence after previous definitive treatment for prostate cancer. The study aims to assess the technical performance of this imaging method in a real-world clinical setting over a 12-month observation period. Each participant undergoes a fluciclovine PETCT scan as part of their routine care. The scans are pseudonymized and centrally reviewed by three independent nuclear medicine physicians who do not know the local sites evaluation. Follow-up assessments occur at one month, including a questionnaire to the referring physician about changes in treatment plans, and at 12 months to gather additional imaging results, PSA levels, treatment outcomes, and histopathological data when available. These follow-ups help confirm true positive and false positive findings. During the study, researchers collect comprehensive data such as additional imaging studies, PSA measurements, and treatment responses to understand the detection accuracy of fluciclovine PETCT. They measure patient-level detection rates and region-level detection rates, analyze detection based on PSA levels, observe changes in intended management, and assess agreement among readers. Participant involvement includes the initial scan and follow-up evaluations over one year, supporting detailed monitoring of disease recurrence and imaging performance.

Researchers are studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

Researchers are evaluating the safety and preliminary effectiveness of CTX112, a CD19-directed CAR T cell immunotherapy, in adults with difficult-to-treat autoimmune diseases such as systemic lupus erythematosus SLE, systemic sclerosis SSc, and idiopathic inflammatory myopathy IIM. This Phase 1, open-label, multicenter study involves genetically modified allogeneic T cells from healthy donors using CRISPR-Cas9 gene editing technology. Participants receive CTX112 through an intravenous infusion following lymphodepleting chemotherapy. The study may include up to 80 subjects and focuses on escalating doses of the therapy to assess safety. The treatment period is followed by long-term monitoring to evaluate the drugs effects over time. During the study, participants undergo scheduled visits, laboratory tests, and evaluations to monitor safety and treatment response. Researchers will assess pharmacodynamics, pharmacokinetics, and preliminary efficacy for up to 60 months after infusion. The primary outcome is safety within the first 28 days post-infusion, with extended follow-up to understand longer-term effects.