Augsburg

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 efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating the clinical utility of serum neurofilament light (sNfL) as a prognostic marker for disease activity in patients with relapsing multiple sclerosis (MS). This prospective, multicenter, observational, non-interventional study in Germany aims to understand how sNfL values can influence patient management and treatment decisions. The study focuses on patients treated with category 1 disease-modifying therapies (DMTs) who have incorporated sNfL testing into their care. Participants will either continue their current category 1 DMT, which includes therapies such as dimethylfumarate, glatiramer acetate, interferon beta, and teriflunomide, or switch to ofatumumab based on their physician’s clinical judgment. There is no treatment allocation by the study itself. Data collection will cover up to 24 months, and the frequency of visits and assessments will follow routine clinical practice without a fixed protocol. During the study, baseline and follow-up data will be gathered according to standard care recommendations, including clinical evaluations and sNfL measurements. Researchers will monitor the proportion of patients with high sNfL levels over time to assess disease activity. The observational period is flexible and guided by the treating physician, with no additional diagnostic or monitoring procedures beyond standard care. Participants will be followed for up to two years to better understand how sNfL influences treatment management in relapsing MS.

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are evaluating asthma control, health-related quality of life (HRQL), lung function, and asthma medication use in patients with severe eosinophilic asthma treated with benralizumab in a real-life clinical setting in Germany. This prospective, non-interventional, single-arm, multicenter study aims to observe these outcomes over a 52-week period to better understand benralizumab's impact outside of randomized clinical trials. Patients prescribed benralizumab according to label and local reimbursement criteria will be followed for up to 52 weeks. The study will monitor asthma control using the Asthma Control Test (ACT) and the Asthma Impairment and Risk Questionnaire (AIRQ®) at various timepoints. Health-related quality of life will be assessed with the mini Asthma Quality of Life Questionnaire (miniAQLQ) at baseline and routine follow-up visits. Patients will also track and report their weekly asthma medication intake using either paper-based or electronic diaries throughout the study. Participants will complete questionnaires every 4 weeks and record medication intake weekly. Researchers will measure changes in ACT scores, proportions of responders, and reductions in inhaled corticosteroid doses from baseline to weeks 12, 24, and 52. Safety and health outcomes will be observed under routine clinical care. This study includes adults aged 18 to 120 years with severe eosinophilic asthma who can understand study instructions and provide informed consent.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) 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 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are investigating the disease status and safety of larotrectinib in children newly diagnosed with high-grade glioma (HGG) that have a TRK fusion. The study focuses on evaluating the disease control rate after two 28-day cycles of larotrectinib monotherapy and also examines survival rates. This pilot study includes a surgical cohort and aims to enroll 15 evaluable patients to assess both disease control and safety of larotrectinib alone or combined with chemotherapy or radiation therapy. Participants will receive larotrectinib orally at 100 mg/m2 twice daily for two cycles. Those with continued complete or complete response will continue larotrectinib maintenance monotherapy for up to 12 cycles, with possible extension to 24 cycles if clinically beneficial. Patients 48 months or younger with partial response or stable disease will receive larotrectinib combined with standard chemotherapy, while older patients or certain DIPG cases will receive focal radiation therapy. A surgical cohort will receive larotrectinib for 3-5 days before surgery followed by two cycles of monotherapy. Throughout the study, participants will be monitored with disease evaluations after treatment cycles, including assessments of tumor response and safety using standardized criteria. Researchers will measure outcomes such as disease control rate and treatment-related adverse events during and after treatment. Pharmacokinetic measures including plasma and tumor concentrations of larotrectinib will also be collected. The study includes safety monitoring during treatment and up to 30 days after protocol treatment ends, with a total planned participation period covering up to 24 cycles of therapy for some patients.

Researchers are evaluating the use of fluciclovine (18F) PET/CT scans to detect recurrent prostate cancer in male patients who previously had a negative or unclear PSMA PET/CT scan. This prospective, bicentric observational study is conducted at two specialized nuclear medicine centers in Germany and focuses on patients experiencing biochemical recurrence of prostate cancer after initial treatment. The study aims to assess the technical performance of fluciclovine PET/CT imaging in a real-world clinical setting over a 12-month observation period. Participants undergo a fluciclovine PET/CT scan as part of their usual clinical care, with all images anonymized and centrally reviewed independently by three nuclear medicine physicians blinded to initial interpretations. Follow-up assessments occur at one month and at twelve months. At one month, a questionnaire collects information from the referring physician about any changes in the planned treatment based on the scan results. At twelve months, comprehensive data including additional imaging, PSA levels, treatment outcomes, and biopsy results, when available, are gathered to confirm the accuracy of the PET/CT findings and distinguish true positives from false positives or negatives. During the study, patients are monitored for one year from enrollment to evaluate the detection rate of recurrent disease. Researchers collect detailed follow-up information to validate scan findings and assess clinical impact. The study seeks to improve understanding of fluciclovine PET/CT's role in managing prostate cancer recurrence and its ability to guide treatment decisions effectively.

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

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), or idiopathic inflammatory myopathy (IIM). This Phase 1, open-label, multi-center study focuses on adults aged 18 to under 70 years who have refractory forms of these autoimmune conditions. CTX112 is made from healthy donor T cells genetically modified using CRISPR-Cas9 technology to target CD19. Participants receive CTX112, an allogeneic T cell therapy prepared outside the body and designed to modify immune responses. The study involves ascending doses to assess safety and gather initial data on treatment effects. The treatment is administered as an infusion. Up to 80 subjects may take part in this study to help understand how well patients tolerate the therapy and its preliminary impact on disease. During the study, participants will undergo various assessments including lab tests and disease activity evaluations. Safety is closely monitored from the time of CTX112 infusion through 28 days afterward. Researchers will track adverse effects and disease symptoms to evaluate both safety and early effectiveness. Participants must comply with scheduled visits, laboratory tests, and other study procedures over the study period to support these evaluations.