Karelia, Russian Federation

Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) in Routine Clinical Practice in the Russian Federation

The index date will be the date of secukinumab initiation. During the study, data will be collected from patients receiving routine secukinumab treatment, which is representative of the actual patient population. The attending physician will decide whether to prescribe secukinumab based on the approved instructions for medical use in a routine clinical setting, regardless of the patient's participation in a non-interventional study.

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.

CLL Therapy Approaches in Russia

A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia

Patients will attend the sites in accordance with routine clinical practice. It is assumed that visits will be conducted every 3-4 months. Patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement. Available data from routine clinical management of the patients will be collected at patients' visits to the clinical site. Patients enrolled in the study will be followed up until death or study close whichever occurs first. The recruitment period is planned for 24 months, observation period for maximum of 24 months, with total duration of study 4 years. Patients may discontinue from this NIS at any time.

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

BIOFLOW-III VIP Russia Registry Orsiro Stent System

For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures. The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice. Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body inflammation status correlates with the clinical outcome.

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.

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.