Tula

Researchers are evaluating the pharmacokinetics, safety, and immune response of two drugs, RPH-030 and Vectibix4, in patients with metastatic colorectal cancer mCRC who have wild-type RAS genes. The study aims to show that these treatments are equivalent in how the body processes them and to compare their safety and immune effects. Additionally, the study will explore how effective these drugs are when used as first-line therapy combined with FOLFIRI chemotherapy. Participants will receive either RPH-030 or Vectibix4 intravenously at 6 mgkg every two weeks along with FOLFIRI chemotherapy, which includes irinotecan, calcium folinate, and fluorouracil. Treatment starts with FOLFIRI for 8 cycles, then continues with a modified de Gramont regimen. The study includes several periods a screening phase, a main period lasting up to 6 months, a continued therapy period up to 1 year where all patients receive RPH-030, and a treatment extension period lasting up to 2 years for patients with stable disease or response. Follow-up visits occur after treatment ends to monitor survival and disease status. Participants will undergo regular tumor assessments approximately every 6 to 8 weeks, hospitalizations for drug administration at specific visits, and blood sampling for pharmacokinetic and safety evaluations. Researchers will monitor drug levels over time, adverse events, immune reactions, and tumor responses. Follow-up includes imaging or phone calls to track overall survival and disease progression. The total study participation can last up to about 2 years with additional follow-up to ensure thorough monitoring of outcomes and safety.

Researchers are studying uncontrolled asthma in adults across Russia to better understand its characteristics and treatment patterns. This large-scale observational registry will include 9,000 patients from 70 outpatient centers in about 50 regions, focusing on those not receiving biologic therapy. The study aims to describe demographic and clinical features, capture complications and comorbidities, and evaluate routine therapies used in real practice. The study has an ambispective design with two main visits. At the first visit, physicians will collect baseline data from the past 52 weeks using medical records and patient interviews. The second visit, conducted 12 weeks later, will gather follow-up information on treatment changes and clinical outcomes. A subgroup of 500 patients using fixed-dose combination budesonidesalbutamol will have an additional third visit 12 weeks after the second to collect further data. Participants will undergo routine clinical assessments during 2 to 3 visits following standard practice. Researchers will examine demographic and clinical data, blood and sputum eosinophil counts, total IgE levels, asthma control status, lung function tests, exacerbation rates, and healthcare resource use. Safety monitoring aligns with routine care, and the study does not involve any experimental treatments or procedures. Total participation spans approximately 24 weeks for those in the extended follow-up group.