Nizhny Novgorod

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.

Researchers are evaluating the safety and effectiveness of a new biosimilar drug called bevacizumab (made by Mabscale, LLC) compared to the existing drug Avastin4 in treating patients with advanced non-squamous non-small cell lung cancer (NSCLC) that cannot be removed by surgery or has recurred or spread. This is a phase III randomized, double-blind trial designed to show that the new bevacizumab works as well and is as safe as Avastin4. The study also includes assessments of how the body processes the drug (pharmacokinetics). Participants will receive treatment with bevacizumab at 15 mg/kg or Avastin4, combined with chemotherapy drugs paclitaxel (175 mg/m2) and carboplatin (AUC 6). This combination is given as the first-line therapy for advanced NSCLC. The study is conducted across multiple centers and participants are randomly assigned to one of the two treatment groups without knowing which they receive. Throughout the study, participants will be monitored for their response to treatment, specifically measuring the Objective Response Rate at 18 weeks after starting therapy. Researchers will also assess safety and side effects. Various tests including tumor measurements, blood tests, and other evaluations will be done to ensure participants meet criteria and to track treatment effects. The total duration includes screening, treatment, and follow-up visits to monitor health and outcomes.

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-281 compared to a reference drug in adults with relapsing-remitting multiple sclerosis (RRMS). This Phase 3 study also examines pharmacokinetics, pharmacodynamics, and immune response to the treatments. The goal is to better understand how these two anti-CD20 monoclonal antibodies perform in people diagnosed with RRMS according to the 2017 McDonald criteria. The study consists of several phases: a screening period up to 28 days to confirm eligibility, followed by a 72-week double-blind phase where participants receive either BCD-281 or the reference drug, then a 24-week open-label phase, and finally a 4-week follow-up. Treatments are given under blinded conditions initially and then openly. Participants are randomly assigned to one of the two treatment groups with equal chance. Throughout the study, participants will undergo assessments including brain MRI scans to measure lesions, neurological evaluations, safety monitoring, and blood tests. The main outcome is the total number of T1 gadolinium-enhancing lesions up to week 24. Safety and treatment effects will be closely tracked during treatment and follow-up periods, which last up to 100 weeks in total.

Bipolar disorder is a serious and long-lasting mood disorder affecting both adults and children, with up to 1.8% of the pediatric population in the United States affected. Treatment options for depressive episodes in children with bipolar disorder are limited due to fewer studies compared to adults. This research aims to evaluate how cariprazine affects disease symptoms and safety in children and teenagers aged 10 to 17 years who have bipolar I disorder with depressive episodes. Participants in the study will be randomly assigned to one of two groups: one receiving cariprazine and the other receiving a placebo, with about half of the participants in each group. Cariprazine will be given as oral capsules in doses adjusted based on age and weight. At the third week, doses may be increased for those not responding well, while others will continue their current dose. The treatment lasts 6 weeks, followed by a 4-week safety follow-up period. During the study, participants will attend weekly visits to hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure changes in depression scores and monitor for any adverse events or abnormal clinical signs, including vital signs, ECG, and movement disorders. The total study duration includes the treatment and safety follow-up periods, ensuring careful observation of participants' health and response to treatment.

This research investigates treatment patterns and the evaluation of homologous recombination repair mutations (HRRm) in circulating tumor DNA (ctDNA) among patients with aggressive high-volume metastatic hormone-sensitive prostate cancer (mHSPC) in the Russian Federation. The study focuses on patients with high-aggressive disease characterized by Gleason scores 8-10 and high-volume disease as defined by specific criteria for bone and visceral metastases. Approximately 400 male patients aged 18 years and older with known tumor HRRm status will participate to better understand demographic and clinical characteristics and treatment approaches in routine practice. The study does not introduce new treatments but observes and collects data as patients receive standard care. Two study visits will occur: the first at baseline to gather medical history, demographic data, and treatment information from diagnosis to enrollment, including routine blood samples for ctDNA and HRRm testing. The second visit will happen at disease progression or after about 12 months to collect follow-up data on progression to metastatic castration-resistant prostate cancer (mCRPC) and subsequent treatments. Blood samples will be analyzed centrally. Participants will have their medical records reviewed and may be interviewed to complete missing information. Data will be entered into electronic records by the study physician. Outcome measures include the proportion of patients receiving various treatments (such as androgen deprivation therapy, chemotherapy, radiation, surgery, and specific inhibitors), duration of therapies, time to progression, mutation presence in ctDNA, testosterone levels, and sites of disease progression over 36 months. Follow-up may be completed by phone if in-person visits are not possible, with the total study duration lasting about 38 months or until data from 400 patients are collected.

Researchers are evaluating the efficacy, safety, pharmacokinetics, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer (TNBC). This Phase 2 study focuses on patients who have received at least one prior systemic therapy and whose cancer has progressed or relapsed. The study aims to better understand how this combination treatment works in later lines of therapy for this aggressive breast cancer subtype. Participants will receive BCD-236 as an intravenous infusion along with chemotherapy, which will be chosen at the investigator's discretion. The study compares this combination treatment's effects and monitors participants over time. The primary outcome measured is the overall response rate at 24 weeks after starting treatment, assessing how well tumors respond to the therapy. Throughout the study, participants will undergo tumor assessments using RECIST 1.1 criteria to measure treatment response. Eligibility requires confirmation of AXL expression in tumor cells from fresh or archival tumor samples. Patients will be monitored for safety and disease progression, with evaluations including physical exams and performance status assessments. The study includes women aged 18 to 74 years with adequate health to participate and a life expectancy of at least four months.

This research aims to understand the clinical and demographic characteristics of adult patients living with Neurofibromatosis type 1 (NF1) in Russia. It is an open-label, single-arm, non-interventional, multi-center cohort study focused on evaluating clinical outcomes and patient-reported experiences in routine care settings. The study includes adults diagnosed with NF1 who have plexiform neurofibromas (PN) confirmed by clinical or imaging methods and who experience symptoms related to PN. The study does not involve any investigational treatments or interventions but observes patients during their routine care. It enrolls adults aged 18 years or older with newly diagnosed PN or established PN who have not been treated with MEK inhibitors for PN. Diagnosis confirmation includes clinical assessment, ultrasound imaging, MRI, or biopsy. Patients with certain cancers requiring chemotherapy or radiation, or those who have recently used MEK inhibitors, are excluded. Participants will undergo a variety of assessments at the start of the study, including measurement of age, body metrics, educational background, NF1 complications, and symptoms related to PN. Researchers will review medical histories, hospitalizations, disability status, and prior examinations. The study collects data on PN volume and duration of symptoms and diagnosis. Follow-up visits and further evaluations will be conducted as per routine care. The study monitors changes in disability and overall health status during participation.

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.