Chatel-sur-moselle, France

Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia

Systemic lupus erythematosus (SLE) is a systemic autoimmune rheumatic disease with variable clinical manifestations and an unpredictable course, affecting any organs or systems, which quite often develops over several months or years, with persistent or, conversely, rapidly changing clinical manifestations, an undulating course, alternating remissions and flares. Currently, in Russia there is no exact data on the number of patients with active moderate to severe SLE in the population, since there is no unified system for regular monitoring of patients with SLE in the country. The systematic information about complications and comorbidities, about the treatment approaches and their effectiveness in the Russian population is also absent. The Russian Federation consists of 85 regions with a total population of more than 145 million people. The regions differ in ethnic composition, age, gender, climate, ecology, economic level, prevalence of SLE in general and moderate to severe SLE in particular. Thus, there is a need to perform a large-scale observational study in regions of the country with a sufficient size of population to obtain information on moderate to severe SLE epidemiology, clinical and demographic characteristics, to describe main clinical outcomes and evaluate existing associations between observed treatment patterns and clinical outcomes in real clinical practice. Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is retrospective and the 2nd is prospective. To allow wide data coverage the study will involve approximately 50 sites of Russian Federation; in each site about 20 patients will be recruited. Overall expected duration of the study (from the first patient inclusion to the last patient last visit) is about 13 months or until 1000 patients will be included in the retrospective phase and ~ 600 patients - in the prospective phase This observational study does not imply any intervention into a routine clinical practice, including choice of treatment modality or special methods of investigation.

An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B

After signing the ICF and screening examination the subjects are to be included in the Non-interventional lead-in period in which the subject will receive standard FIX prevention. The lead-in period will last for at least 6 month for every subject. After completiong the lead-in period subjects will enter the main (interventional) period. At the first visit of the main period subjects will recieve investigational product ANB-002. The main period ends 18 months after the administration of ANB-002, after which subjects will switch to the follow-up period and will be evaluated up to 5 years after the ANB-002 infusion.

Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases

This is a phase 2/3 study with double-blind parallel-group adaptive design. The study will include the following periods: 1. Screening period (4 weeks) Screening period (before the first administration of the test drug). Before being included in the study, patients will be provided with complete information about this clinical trial and signs the Informed consent Form (IF). After that the researcher will decide whether or not the patient can be randomized into the study. 2. Double-blind Treatment period (48 weeks). Following the completion of a Treatment period, all patients will be enrolled in Follow-up Period (FU). 3. Follow-up Period (24 weeks). During the FU Period, patients will visit study sites after 4,12 and 24 weeks after the end of the Treatment Period to complete FU-1 (Week 52), FU-2 (Week 60) and FU-3 (Week 72) visits. The overall study duration for the patients will be approximately 76 weeks (including the 4 weeks screening period) The analysis will be conducted in two sequential steps: - the interim analysis after 61 percent (%) of patients have completed the Treatment period (not including the FU period) - the final analysis when all patients have completed all periods (the Treatment and the FU periods).

Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children with Moderate to Severe Plaque Psoriasis

Following screening, subjects will be randomized to receive either netakimab, placebo or adalimumab in a 2:1:2 ratio and enter the main study period. During the main study period, subjects will receive therapy with netakimab/placebo (double-blind arms) or adalimumab (open-label arm), which will be administered subcutaneously until week 12. At Week 12, after completion of all scheduled procedures subjects in groups netakimab/placebo will continue to receive open-label netakimab for up to week 58, subjects in group adalimumab will switch to open-label adalimumab after 8-week "washout" period. At Week 58, after completion of all scheduled procedures subjects with sPGA ≤1 will be re-randomised to recieve either netakimab or placebo in double-blind maner. The subjects with >1 will continue to recieve open-label netakimab.

A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation

In this study, an index event is a start of ribociclib+ET treatment. Post-index follow-up period is 24 months or until treatment discontinuation. The recruitment period is planned for 12 months. The interim analyses will be performed after enrollment is complete, and further one year later. Patients will visit the sites in accordance with routine clinical practice. It is assumed according to the clinical practice that visits will be conducted every 3-4 months. Patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement.

Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)

Early safety (morbidity, mortality rate, freedom from any valve related complication) along with clinical efficacy ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), long term outcomes ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), echocardiografic assessment and MSCT scan for both groups of patients are going to be evaluated.

Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)

There are limited epidemiological data of the patients with uncontrolled severe asthma in Russia since there is no unified system for regular monitoring of patients with severe asthma in the country. The systematic information about complications and comorbidities, about the treatment approaches and their effectiveness in the Russian population is also absent. The observational registry is really important to describe the epidemiological characteristics of the disease and to analyse the clinical characteristics of the various subgroups of patients. This is an excellent starting point to be able to investigate the characteristics of the disease in detail. The Russian Federation consists of 85 regions with a total population of more than 145 million people. The regions differ in ethnic composition, age, gender, climate, ecology, economic level, prevalence of asthma in general and severe asthma in particular. Previously reported observational registries are International Severe Asthma Registry (ISAR) and Russian Severe Asthma Registry (RSAR), both studies included patients regardless of whether patients received biological agents or not. The percentage of patients receiving biologics in these studies was 25.4% and 10.6% respectively. Thus, there is a need to perform a large-scale observational registry in regions of the country with a sufficient size of population to obtain information on SA epidemiology, clinical and demographic characteristics, to describe main clinical outcomes and evaluate existing associations between observed treatment patterns and clinical outcomes in real clinical practice in patients with uncontrolled SA not receiving biologic therapy. Trial will have cross-sectional design and will include 1 visit for obtaining the patient's demographic and clinical data. To allow wide data coverage the study will involve at least 50 regions of Russian Federation; in each region 100 patients will be recruited. The total size of study population will be 5 000 patients.

A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma

PRospectIve ObseRvatIonal mulTicenter Study of Patients With Arterial hYpertension and CKD in the Population of Russia

Timely chronic kidney disease (CKD) detection is important for slowing or preventing of kidney function deterioration, reducing cardiovascular complications and mortality. Unfortunately, early-stage CKD is primarily asymptomatic, and due to lack of symptoms CKD is often diagnosed only in advanced stages. There are limited epidemiological data of the overall CKD prevalence in Russia. In Russia there is Federal diabetes registry that includes data of diabetes kidney disease among others, so the population of patients with diabetes mellitus (DM) and CKD is more studied. Besides the diabetes, AH is also considered one of the major etiological factors for CKD development and progression, but the population of patients with AH and CKD is less studied. Available studies that assess renal function in patients with AH are cross-sectional with one-time assessment of kidney function. The diagnosis of CKD should be established, if CKD markers are observed over 3 or more months, so it is required to assess the markers of kidney function and/or kidney damage overtime to confirm chronic condition. There is a need to conduct a large observational study in patients with AH and CKD markers to describe the rate of CKD diagnosis in this patient population. Recorded diagnosis of CKD is an important first step to reduce the risk of disease progression and minimize adverse clinical outcomes. The current study will enroll patients with AH and without previously diagnosed DM and symptomatic heart failure that will allow focusing on evaluating the prevalence of newly diagnosed CKD in patients with hypertension. This study is a multi-center, non-interventional, observational, prospective study with retrospective analysis. Planned study population for prospective analysis consists of 10 000 adult outpatients with AH and one or more CKD markers, without recorded CKD diagnosis prior to enrolment, and without recorded diagnosis of DM or symptomatic chronic heart failure (CHF). Planned number of study sites is approximately 50 outpatient sites in about 20 regions of Russia. Retrospective part includes retrospective review by the physician of paper or electronic medical records of patients with recorded diagnosis of AH for the presence of laboratory CKD markers, measured within the period of ≤12 months prior to inclusion into the study. Patients with one or more CKD markers recorded in their medical records (without recorded CKD diagnosis) can be included in the prospective part of the study. Demographic and clinical characteristics, including medical history, CKD markers, will be collected retrospectively from all enrolled patients. In case of enough retrospective data for the period of ≤12 months prior to inclusion to confirm CKD diagnosis according to the current clinical guidelines (two consecutive evaluations of CKD marker(s) with the interval between two measurements not less than 3 months), the CKD diagnosis can be confirmed and recorded. Otherwise, the laboratory testing will be performed to confirm or exclude the CKD diagnosis. Overall expected duration of the study (from the first patient inclusion to the last patient last visit) is 18 months, or until 10 000 eligible patients are included to the study and data on these patients are collected, whichever occurs first. This non-interventional study does not imply any intervention into a routine clinical practice, and does not provide for any diagnostic and therapeutic procedures other than those used in routine practice.

Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis

This observational study will be performed at healthcare facilities treating pediatric psoriasis patients. The study population will consist of a representative group of pediatric patients with moderate-to-severe plaque psoriasis for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 16 weeks Retrospective data collection is planned at patients' inclusion. Prospective data collection will continue during follow-up routine visits until secukinumab discontinuation or maximum duration of follow-up for 104 weeks after index date.