Tula

Researchers are evaluating the pharmacokinetics, safety, and immune response of two treatments, RPH-030 and Vectibix®, in patients with metastatic colorectal cancer (mCRC) who have wild-type RAS genes. This phase I, multicenter, double-blind, randomized study aims to demonstrate that these treatments have equivalent pharmacokinetic properties when given as first-line therapy in combination with the chemotherapy regimen FOLFIRI. The study also includes a pilot evaluation of the efficacy of these treatments. Participants will be randomly assigned to receive either RPH-030 or Vectibix® intravenously at a dose of 6 mg/kg every two weeks alongside FOLFIRI chemotherapy. Treatment will continue for up to two years or until disease progression, unacceptable toxicity, or withdrawal of consent. The study is divided into several periods: a screening period lasting up to 27 days (extendable to 42 days if biopsy is needed), a 6-month main treatment period, a continued therapy period up to one year, a treatment extension period for responders lasting up to two years, and a follow-up period after treatment ends. During the study, patients will undergo regular tumor assessments approximately every 6 to 8 weeks depending on the study phase. Hospitalizations of at least 24 hours will occur at certain visits for drug administration. Researchers will monitor drug levels in the blood at multiple time points to understand treatment pharmacokinetics. Follow-up will include imaging tests, survival data collection, and safety monitoring until one year after treatment or until patient withdrawal or death. The goal is to assess treatment safety, immune response, effectiveness, and patient well-being throughout the study timeline.

Researchers are conducting a large, non-interventional observational study to better understand adults with uncontrolled asthma across Russia. This study aims to gather detailed information on the demographic and clinical characteristics of these patients, the treatments they receive, and how their condition is managed in routine clinical practice. The study focuses on patients not treated with biologics and covers a diverse population from about 50 regions in Russia, reflecting differences in ethnicity, climate, and economic status. The study will include 9,000 adult patients with uncontrolled mild to moderate asthma who are receiving standard care. Data will be collected during 2-3 visits that follow routine clinical practice schedules. At the first visit, information from the previous 52 weeks will be gathered from medical records and patient interviews. The second visit will take place about 12 weeks later to collect follow-up data on treatment changes and clinical outcomes. For a subgroup of 500 patients using a fixed-dose combination of budesonide/salbutamol at the second visit, an additional third visit will occur 12 weeks later to further monitor treatment and outcomes. Participants will be monitored through medical record reviews and interviews during these visits. Researchers will assess baseline characteristics such as blood eosinophil counts, sputum eosinophils, and total IgE levels, along with treatment profiles and clinical outcomes. The study does not involve any experimental interventions beyond standard care and aims to provide comprehensive real-world data on uncontrolled asthma management in Russia. The total study duration for participants includes up to 24 weeks of follow-up for some patients.

Researchers are conducting a multi-center, non-interventional study to observe routine diagnostic and treatment practices for patients with unresectable or inoperable locally advanced non-small cell lung cancer (NSCLC) and limited-stage small cell lung cancer (LS-SCLC) in 50 major oncology centers across Russia. The study will collect data from 2000 patients receiving chemo-radiation therapy (CRT) over two years. The aim is to understand demographic and clinical characteristics, diagnostic procedures, treatment approaches, and short-term outcomes of CRT in these patients, without collecting information on treatments following CRT such as durvalumab. The study involves collecting data at two main points: at the start of CRT (either concurrent or sequential chemo-radiation) and after the last dose of radiation therapy, including results from computed tomography (CT) scans. Data collection will be done from patients' medical records in routine clinical practice, and the second data collection is expected to occur within six months after the first visit. The study follows local regulations for adverse event reporting and does not involve additional interventions or treatments. Participants will be adults aged 18 years or older who have locally advanced NSCLC or LS-SCLC and are currently undergoing radiation therapy as part of CRT. Researchers will gather information on patient demographics, disease stage, histology, and clinical status at baseline. The study will monitor treatment details and short-term outcomes after CRT. All data is collected from existing medical records, ensuring no extra procedures for participants. The total participation duration aligns with routine treatment schedules and follow-up visits.

Researchers are evaluating the rate of chronic kidney disease (CKD) diagnosis in adults with arterial hypertension (AH) who have laboratory markers indicating possible CKD but no prior recorded CKD diagnosis. The study focuses on patients without diabetes mellitus or symptomatic chronic heart failure and aims to better understand CKD prevalence in this specific population in Russia. This multi-center, non-interventional, observational study includes both prospective and retrospective data analysis involving about 10,000 adult outpatients from approximately 50 outpatient sites across 20 regions of Russia. The study will not involve any new diagnostic or treatment procedures beyond routine clinical practice. Retrospective data will be collected from medical records to identify CKD markers measured within 12 months before study inclusion. Patients with adequate retrospective data may have CKD diagnosis confirmed based on two evaluations at least 3 months apart. Those without sufficient retrospective data will undergo laboratory testing during the prospective study period, which will last up to 18 months or until data from 10,000 patients are collected. Participants will be monitored and treated by cardiologists or internal medicine specialists during routine visits. Researchers will collect demographic and clinical information, including medical history and CKD markers, from both retrospective and prospective records. The main outcome is the rate of new CKD diagnoses over the 18-month follow-up. No additional interventions or procedures beyond usual care will be performed, and the study aims to support earlier CKD detection and improved clinical outcomes in patients with hypertension.