Petrozavodsk

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

Researchers are evaluating the efficacy and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma, a condition where the disease has returned or is resistant to previous therapies. This open-label phase 2 clinical study aims to assess the overall response rate and other important outcomes in this patient population. The study is sponsored by Biocad and focuses on patients who have received multiple prior treatments including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants will receive BCD-248 administered subcutaneously. The study monitors various outcomes including overall response rate up to 24 weeks and progression-free survival up to 104 weeks, among others, over a total duration extending to about 3.7 years for some measures. Pharmacokinetic parameters like Cmax, Cmin, AUC0-t, and Ctrough will be tracked shortly after administration and up to 6 months. Additional assessments include measurement of soluble BCMA levels and the presence of binding and neutralizing antibodies. During the study, participants will undergo regular evaluations including disease assessments based on International Myeloma Working Group criteria, safety monitoring for adverse events, and laboratory tests. Long-term follow-up will include evaluation of response duration, time to response and progression, and overall survival. The study started in December 2024 and is expected to continue until July 2028, providing extended observation for participant outcomes and safety.

Researchers are conducting an observational multicenter cross-sectional study involving 5,000 adult patients in Russia with uncontrolled severe asthma SA who are receiving standard care treatments except biologics. The study aims to describe the characteristics of these patients across about 50 outpatient centers in 50 regions of Russia, addressing the lack of unified data on severe asthma epidemiology, complications, comorbidities, and treatment patterns in the country. Participants will have a single study visit where demographic and clinical data will be collected without any additional interventions or changes to their routine care. The study will gather information on treatment patterns, including the use of oral corticosteroids and various medication classes, and analyze clinical and demographic features such as age at diagnosis, gender distribution, body mass index, lifestyle factors, and presence of comorbidities. During the study, researchers will review medical records and follow-up data from the prior 52 weeks to assess treatment changes, exacerbations, healthcare resource use, and lung function parameters. No extra diagnostic or therapeutic procedures will be performed beyond standard practice. The study will run from June 2024 to June 2027, aiming to provide detailed epidemiological insights into uncontrolled severe asthma in the Russian adult population.

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.

The trial investigates the safety and effectiveness of olokizumab compared to a placebo in adults with progressive fibrosing interstitial lung diseases ILD. This phase 23 study uses a double-blind, parallel-group adaptive design to better understand treatment impacts on lung function over time. Participants have progressive fibrosing ILD confirmed by imaging and lung function tests, with disease progression documented within the prior months or years. Participants will be randomly assigned to receive either subcutaneous injections of olokizumab 64 mg or placebo every four weeks during a 48-week treatment period. The study includes a screening period lasting four weeks, followed by a treatment period of 48 weeks, and then a follow-up period of 24 weeks with visits scheduled at 4, 12, and 24 weeks post-treatment. The total duration of participation is approximately 76 weeks. Throughout the study, patients will undergo lung function tests including forced vital capacity FVC and diffusion capacity for carbon monoxide DLCO, as well as imaging assessments to evaluate lung fibrosis. Researchers will monitor symptoms, lung function changes, and quality of life measures using dyspnea scores and health questionnaires. Safety will be closely observed during treatment and follow-up visits, with the main outcome focused on changes in FVC over 48 weeks.

Researchers are evaluating clinical outcomes for patients who begin inclisiran treatment within about two weeks after experiencing a heart attack STEMI or non-STEMI. This observational study focuses on patients in Russia and aims to understand the effects of inclisiran on lipid profiles, safety, atherosclerotic plaque status using carotid ultrasound, and the rates of hospitalizations and intensive follow-up over a 12-month period. Participants receive their first inclisiran injection approximately 14 days after their heart attack. The study observes changes in lipid levels at baseline, 3, 9, and 12 months, as well as plaque progression or regression over the year. Researchers also monitor adverse events, therapy discontinuation, hospital readmissions, emergency care visits, and the timing of dispensary observation. During the 12 months of participation, patients undergo lipid profile testing, carotid ultrasound scans, and safety evaluations at specified intervals. The main measure is the number of patients experiencing atherosclerotic cardiovascular disease events within a year after starting inclisiran in addition to their usual therapy. Secondary assessments include LDL cholesterol levels, plaque changes, adverse events, rehospitalizations, and use of emergency services, all tracked to evaluate the therapys impact and safety in real-world settings.

Researchers are investigating the use of lisaftoclax combined with BTK inhibitors in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL who have previously been treated with BTK inhibitors. This global, open-label, phase III study aims to evaluate the effectiveness and safety of this combination compared to BTK inhibitor alone in patients who have been on BTK inhibitor monotherapy for at least 12 months. About 440 participants will be randomly assigned to one of two groups one will receive lisaftoclax together with a BTK inhibitor, and the other will receive only a BTK inhibitor. The study uses a parallel design where participants are allocated equally to each treatment arm to compare outcomes clearly. Both treatments are administered under medical supervision, and the study is open-label, meaning both the researchers and participants know which treatment is given. Participants will be assessed regularly over the course of the study, with evaluations including disease progression measured at 12 months and overall survival also tracked at 12 months. Eligibility screening includes assessments of performance status, bone marrow, kidney, and liver function, as well as consent to follow the study schedule. The research team monitors safety and treatment effects throughout the trial, which is expected to complete by late 2027.

Researchers are investigating how other existing health conditions affect the risk of complications after abdominal surgery. This observational study aims to understand the frequency and types of additional diseases among surgical patients and identify key factors that predict postoperative problems. The goal is to help better assess and manage risks for patients undergoing planned abdominal operations. The study collects information about patients age, gender, physical status by the ASA scale, presence of various diseases such as heart, lung, kidney, neurological, and metabolic conditions, and treatments they receive. It also records details about the type and severity of surgery, anesthesia methods, and uses various assessment scales related to cognition, respiratory and cardiovascular risk, liver and kidney function. Data is gathered before surgery and patients are monitored until hospital discharge. Participants provide informed consent and their data is entered into a secure database. Researchers evaluate factors influencing complications within 7 days after surgery, as well as mortality within 30 days. Statistical analysis includes regression models to identify independent risk predictors. The study involves multiple centers and follows patients throughout the hospital stay, aiming to improve understanding of postoperative risks and guide preventive strategies.