Wetzlar

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 investigating targeted therapies to treat adults with moderately to severely active Rheumatoid Arthritis (RA), a chronic inflammatory disease that causes pain, stiffness, swelling, and loss of joint function. This Phase 2 study includes three substudies that evaluate different treatments for participants who have not responded well to one or two prior biologic or targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies. The study aims to assess both the effectiveness and safety of these therapies. The study tests three treatment approaches: lutikizumab alone, ravagalimab alone, and a combination of lutikizumab and ravagalimab, each compared against placebo. All treatments are given by subcutaneous injection. About 180 participants will be enrolled across approximately 65 sites worldwide. Participants must be on a stable dose of methotrexate to join the study. The study requires regular visits to hospitals or clinics for treatment and monitoring. During the study, participants will undergo medical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. The main outcomes measured include the percentage of participants achieving a 50% improvement in Rheumatoid Arthritis symptoms by week 12 and the number of participants experiencing adverse events up to about week 22. Participants may have a higher treatment burden than usual care due to the study procedures and visits.

This research aims to compare two ways of giving the drug bimekizumab to adults with active psoriatic arthritis or active axial spondyloarthritis. The study focuses on whether giving bimekizumab through an intravenous (IV) injection is not worse than giving it as a subcutaneous (under the skin) injection. The trial is designed as an open-label, randomized, parallel-group, noninferiority phase 1 study to evaluate how the drug moves and stays in the body over time. Participants will receive bimekizumab at scheduled times either through one of two intravenous regimens or a subcutaneous regimen. Each group will follow a specific dosing plan to see how the drug behaves in the body depending on the method of administration. The study treatments are given at pre-set time points, and the goal is to measure drug concentrations in the blood. During the study, participants will be monitored and assessed for the drug concentration in their blood at week 16 to understand steady-state trough levels. Researchers will also check for safety and tolerability throughout the study. The total duration and further assessments are not specified, but the focus is on comparing the drug levels and safety between the different administration methods in adults with these active conditions.

Psoriatic arthritis (PsA) is a type of arthritis that causes joint swelling and stiffness and is often seen in people with the skin condition psoriasis. It results from an overactive immune system attacking healthy tissue. This research aims to describe the long-term use and effectiveness of risankizumab (RZB) compared to other advanced treatments for managing PsA in everyday clinical care. The study is not conducted in the United States but will take place in about 15 countries and include between 900 and 1200 adult participants. Participants will be assigned in a 2 to 1 ratio to receive either risankizumab or other advanced therapeutic agents. The treatments will be given following usual medical guidelines, including approved dosing and indications, as determined by local regulations and professional standards. All study visits will occur during routine clinical care with no extra burden on participants. Participants will be followed and monitored for 24 months to observe treatment persistence. During the study, participants will continue their regular clinical visits without additional procedures or tests required by the study. Researchers will measure how many participants continue their prescribed treatment over the 24-month period. The study focuses on real-world treatment patterns and outcomes in patients with active PsA who have previously shown an inadequate response or intolerance to certain medications. Safety monitoring will align with routine clinical practice throughout the study duration.

Researchers are evaluating the real-world effects of subcutaneous anifrolumab treatment in adults with systemic lupus erythematosus (SLE) who have not previously used anifrolumab. This non-interventional, prospective, multicenter study aims to assess disease activity, patient quality of life, medication use, flares, and organ damage over a 24-month period in routine clinical care settings. Participants will receive subcutaneous anifrolumab according to European prescribing guidelines, with treatment decisions made independently of the study. This observational study does not involve additional interventions but follows patients receiving this therapy as part of their regular care. During the 24-month observation, participants will undergo clinical evaluations and report outcomes related to disease activity, remission status, quality of life, medication patterns, and organ damage progression. Researchers will measure the proportion of patients achieving remission according to the DORIS criteria at 24 months, alongside monitoring flares and other important clinical outcomes.

The trial investigates the effectiveness, safety, and patients' quality of life when using additive chemotherapy after surgery or ablation in patients with metastatic colorectal cancer. This phase III, open-label, randomized, controlled, multicenter study compares two groups: one receiving chemotherapy and the other undergoing active follow-up without additional treatment. All patients have had their metastatic lesions definitively treated before joining the trial. Participants in the chemotherapy group receive up to six months of treatment with either mFOLFOXIRI or mFOLFOX-6, with up to 12 cycles administered every two weeks. The other group undergoes active surveillance without further chemotherapy. The study includes regular tumor biopsies at screening and upon relapse if possible, aiming to study tumor and blood markers. Imaging scans such as CT or MRI of the chest and abdomen are performed every three months during the first two years, then every six months thereafter, with follow-up continuing for up to five years. Throughout the study, patients are monitored every three months with radiologic assessments, blood tests, and quality of life questionnaires. Researchers aim to detect any cancer relapse through imaging and blood markers and evaluate progression-free survival over 24 months. Safety and clinical status are regularly assessed, and structured follow-up is maintained for both groups up to 60 months after randomization.

Researchers are studying both early and advanced/metastatic breast cancer to improve therapy decisions and healthcare quality. Metastatic breast cancer patients often have the poorest prognosis, and there is a need to better understand tumor characteristics to guide targeted therapies. This study aims to establish methods for analyzing molecular features of tumors and metastases using blood samples, as tumor biopsies can be invasive and are not routinely performed despite recommendations. Participants will have blood samples taken during routine blood draws to analyze tumor expression, mutations, gene copy number changes, and other molecular markers. The study focuses on creating a comprehensive infrastructure for molecular assessment in breast cancer patients at different stages. The research also explores healthcare outcomes and economics to enhance patient integration and awareness. Participants will be monitored to discover biomarkers that predict progression-free survival in metastatic breast cancer and assess disease-free survival in early breast cancer over up to 60 months. The study involves routine clinical assessments and blood collections, with data collected on tumor characteristics and patient health outcomes. Overall participation spans long-term follow-up to evaluate progression and survival measures.

Researchers are evaluating the treatment and disease progression in men with recurrent or metastatic prostate cancer through a long-term registry study. The study includes patients with four distinct prostate cancer conditions: biochemical recurrence after surgery or radiation, non-metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and metastatic castration-resistant prostate cancer. Each group is studied independently during different time periods to better understand their treatment courses and disease outcomes. There is no specific treatment assigned by the study. Instead, patients receive care according to the usual medical practice at their treatment centers. Treatments may vary and are decided by each patient's doctor. Data is collected at routine visits after enrollment, then every 3 or 6 months, and whenever therapy changes. This includes recording treatments, disease status, quality of life questionnaires (FACT-P and EQ-5D-5L), and collection of biomaterial. Participants will be involved in regular follow-up visits where their disease progression and therapy details are documented. The study monitors therapy frequencies and patterns for an average of 7 years. Researchers assess these long-term outcomes along with quality of life and other clinical data to better understand prostate cancer management in real-world settings.

Researchers are evaluating the real-world clinical use and outcomes of men with metastatic castration-resistant prostate cancer (mCRPC) who are treated with a combination of olaparib and abiraterone. The study focuses on patients who have either not previously received next-generation hormonal agents (NHA-naive) or who have been exposed to NHAs before starting this combined treatment. This prospective observational study aims to describe patient demographics, clinical characteristics, and treatments before and after olaparib plus abiraterone therapy. The study will enroll patients who have started treatment with olaparib plus abiraterone after the study site became active. It will follow patients for up to 2 years to collect data on their treatment experience. No experimental interventions are administered as part of the study; instead, it observes patients receiving standard treatment in routine clinical settings. Participants will be monitored from the start of olaparib treatment until one year after the last patient enrolls. Researchers will collect clinical data to assess treatment discontinuation times and overall outcomes during this period. The study will capture information on patients’ clinical progress and any subsequent therapies, providing insights into the real-world effectiveness and use of this treatment combination.