Petrozavodsk

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

This research aims to provide ongoing access to treatments for participants with multiple myeloma or smoldering multiple myeloma who are benefiting from treatment in certain Janssen studies that include daratumumab. It allows all participants from daratumumab studies and those in daratumumab-containing arms of related studies, which have reached clinical cutoff for final analysis, to continue treatment. The study also collects long-term safety data from these participants. The treatments being evaluated include daratumumab, which is given either intravenously or subcutaneously, carfilzomib administered intravenously, dexamethasone given orally or intravenously, and oral medications lenalidomide and pomalidomide. Participants will continue to receive these treatments as part of this long-term extension study following their previous study treatment. During the study, participants will be monitored for safety, including tracking serious adverse events, adverse events of special interest, pregnancies, and abnormal pregnancies over a period of 3 years and 7 months. Assessments include pregnancy testing for women of childbearing potential and adherence to lifestyle restrictions. Participants must provide informed consent and will be followed closely to evaluate the long-term effects and safety of their treatment.

Researchers are evaluating the effectiveness and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma. This open-label Phase 2 study focuses on individuals who have previously received at least two lines of therapy, including specific treatments like proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants must have measurable disease and documented progression according to established criteria. The study treatment involves administering BCD-248 subcutaneously. Patients eligible for the trial will receive this investigational drug during the study period. There are no comparator groups mentioned, and the treatment is given as a single intervention. This trial does not mention additional phases or extension periods. Participants will be monitored for their overall response rate to treatment up to 24 weeks, based on criteria set by the International Myeloma Working Group. Assessments include disease evaluations and safety monitoring. The study involves careful screening to ensure participants meet specific health and prior treatment requirements, with follow-up to track treatment outcomes and adverse events throughout the study duration.

Researchers are conducting an observational multicenter cross-sectional study to better understand the characteristics of adults with uncontrolled severe asthma in Russia who are not receiving biological therapy. The study aims to collect detailed information on the epidemiology, clinical features, treatment patterns, and demographics of these patients across different regions of the Russian Federation, which vary widely in population composition and environmental factors. The study will help fill the gap in data about severe asthma in Russia, especially in patients treated according to standard care but excluding biologics. The study plans to include 5,000 adult patients from about 50 outpatient centers across 50 regions of Russia. It will collect routine clinical data without altering standard medical care or introducing any new diagnostic or therapeutic procedures. The study design includes one visit per patient to gather demographic, clinical, and treatment information, focusing on patients with uncontrolled severe asthma receiving standard treatments like inhaled corticosteroids with other medications but not biological agents. Participants will provide data through medical records and assessments such as the Asthma Control Questionnaire. Researchers will analyze patterns of drug use, clinical characteristics including comorbidities, blood counts, immunoglobulin levels, and lifestyle factors. The study will characterize patients' demographics, treatment trends, and asthma control status from June 2024 to June 2027. Safety monitoring is observational, with no intervention beyond routine care, and the total participation involves a single study visit.

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 evaluating the effectiveness and safety of olokizumab (OKZ) compared to a placebo in patients with progressive fibrosing interstitial lung diseases (ILD). This phase 2/3 study uses a double-blind, parallel-group, adaptive design to assess treatment impact on lung function. Progressive fibrosing ILD is confirmed by imaging and lung function tests, with disease progression criteria including declines in lung capacity and worsening symptoms. Participants will receive subcutaneous injections of either 64 mg olokizumab or placebo every 4 weeks during a 48-week double-blind treatment period. The study begins with a 4-week screening period before treatment starts. After completing treatment, all participants enter a 24-week follow-up phase with visits at weeks 52, 60, and 72 to monitor ongoing effects and safety. Throughout the study, patients will undergo lung function tests, imaging reviews, and assessments of respiratory symptoms. Researchers will measure changes in forced vital capacity (FVC) over 48 weeks as the primary outcome. Safety and adverse events will be monitored during treatment and follow-up. The total participation time is about 76 weeks, including screening, treatment, and follow-up periods.

Researchers are studying the effects of early inclisiran treatment in patients who have experienced a heart attack, specifically STEMI or non-STEMI, in real-world settings in Russia. The study focuses on patients with myocardial infarction and dyslipidemia, aiming to evaluate the clinical outcomes over 12 months after starting inclisiran in addition to basic therapy. Key goals include understanding how this treatment affects lipid profiles, the safety of the therapy, the condition of atherosclerotic plaques using carotid ultrasound, hospitalization rates, and the need for intensive follow-up care. Participants will receive their first inclisiran injection within approximately two weeks after their heart attack. The study observes the effects of this early treatment across a 12-month period, monitoring how inclisiran influences cholesterol levels and cardiovascular health alongside usual care. The research is designed to capture real-world data on inclisiran's impact on patients recovering from myocardial infarction. During the study, participants will be monitored for heart-related events, changes in cholesterol levels, and the status of arterial plaques. Researchers will also track hospital admissions and assess the safety of the treatment. The main outcome measured is the number of patients who experience atherosclerotic cardiovascular disease events within 12 months after starting inclisiran. Overall, the study aims to provide a comprehensive understanding of inclisiran's effects on heart health over one year.

Researchers are studying the presence and types of other health conditions in patients having abdominal surgery to better understand and categorize the risk of complications after surgery. The goal is to identify which existing diseases independently predict such risks, as this knowledge is important for informed consent and planning preventive care. The study focuses on adults with certain physical health statuses undergoing planned operations, noting that while anesthesia risks have decreased, complications remain a significant concern worldwide. The study collects detailed information before surgery about patient age, gender, physical status (ASA classification), various chronic diseases like heart, lung, kidney, neurological disorders, and diabetes, as well as treatments the patient is receiving. It also records the type and severity of different abdominal surgeries and anesthesia methods used. Data is gathered uniformly from multiple centers and entered into an electronic database. The study includes patients operated on within defined days and monitors them until hospital discharge. Participants will have their health and surgical data collected and tracked, including cognitive function, respiratory and cardiac risk scales, and kidney and liver function. Postoperative complications occurring within 7 days of surgery are the main outcomes measured. The study plans to enroll a large number of patients to develop reliable risk prediction models, with ongoing data analysis using statistical methods to identify significant predictors. Results will be validated with additional patient groups to improve accuracy and clinical usefulness.