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The article is discussing the data of additional analyses of subpopulation of MS patients from Russia, participating in phase III clinical trials of DMTs (article by E.P. Evdoshenko et al in this issue). This review the data of alemtuzumab trials CARE-MS I and CARE-MS II with special attention to Russian patients. Such statistics allows to find new peculiarities of the drug effectiveness, selection of groups of patients, showing better results in MS patients with high disease activity, but low residual disability. Data of longitudinal observations are of special interest. Presented data on the 8-years observation of MS after alemtuzumab therapy show low annual relapse rate (mean 0,14-0,18) and stable disability levels, even with confimed disability improvement of EDSS in 41-47% of patients.
This article was published in the following journal.
Name: Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova
To study the efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis (SPMS) in the Russian population of the EXPAND study.
Steroid pulse therapy has shown satisfactory efficacy and safety in treating pemphigus vulgaris. However, there is a paucity of data about the efficacy and safety of methylprednisolone, despite its fr...
Objective The effects of stem cell therapy in patients with advanced heart failure is an ongoing debate. This study aimed to assess the effectiveness and safety of stem cell therapy plus the standard ...
The efficacy and safety of hypofractionated radiation therapy (HFRT) combined with immune checkpoint inhibitors (ICIs) in patients with brain metastases (BM) remain controversial. This meta-analysis w...
Osteoporosis is a major complication in patients with primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH). Denosumab, a fully human monoclonal antibody against the receptor activator of n...
This study will investigate antihypertensive activity and safety profile of Tarka in Russian hypertension patients by ambulatory blood pressure measurement (ABPM)
100 Russian children of 2 years of age and less with risk factors (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as a prophylaxi...
This study is being performed to evaluate what variants of lipid-lowering therapy are used in Russian clinical practice in CHD patients with hypercholesterolemia in whom the initial statin...
The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation.
The purpose of the study is to assess the short term efficacy of the Theraflu Aktiv powder for oral solution in the Russian population as compared to an untreated group to support the indi...
Work that is a report of a planned post-marketing study of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale after clinical trials, phases I, II, and III. These studies, conducted in the United States or a foreign country, often garner additional data about the safety and efficacy of a product.
Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries.
Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques based on several hundred volunteers, including a limited number of patients, and conducted over a period of about two years in either the United States or a foreign country.
A class of statistical procedures for estimating the survival function (function of time, starting with a population 100% well at a given time and providing the percentage of the population still well at later times). The survival analysis is then used for making inferences about the effects of treatments, prognostic factors, exposures, and other covariates on the function.
Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques after phase II trials. A large enough group of patients is studied and closely monitored by physicians for adverse response to long-term exposure, over a period of about three years in either the United States or a foreign country.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g...