Sovet, Belgium
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.
Phase
N/ASpan
160 weeksSponsor
Novartis PharmaceuticalsBarnaul
Recruiting
Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® As Monotherapy in Subjects with Advanced Melanoma of the Skin
Following screening, subjects will be randomized to receive either BCD-263 or Opdivo in a 1:1 ratio and enter the main study period. During the main study period, subjects will receive therapy with BCD-263 or Opdivo, which will be administered intravenously until disease progression or signs of unacceptable toxicity develop (whichever occurs earlier). At Week 25, after completion of all scheduled procedures subjects in both groups will continue to receive open-label BCD-263 for up to a total of 2 years of therapy, or disease progression, or signs of unacceptable toxicity (whichever occurs first). Following discontinuation of the study therapy, the subjects will enter a follow-up period, during which data on overall survival will be collected through telephone contacts.
Phase
3Span
158 weeksSponsor
BiocadBarnaul
Recruiting
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.
Phase
3Span
186 weeksSponsor
BiocadBarnaul
Recruiting
A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
Following screening, subjects will be randomized to receive either BCD-263 or Opdivo in a 1:1 ratio and enter the main study period. During the main study period, subjects will receive therapy with BCD-263 or Opdivo, which will be administered intravenously until disease progression or signs of unacceptable toxicity develop (whichever occurs earlier). At Week 25, after completion of all scheduled procedures subjects in both groups will continue to receive open-label BCD-263 for up to a total of 2 years of therapy, or disease progression, or signs of unacceptable toxicity (whichever occurs first). Following discontinuation of the study therapy, the subjects will enter a follow-up period, during which data on overall survival will be collected through telephone contacts.
Phase
1Span
192 weeksSponsor
BiocadBarnaul
Recruiting
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).
Phase
2/3Span
279 weeksSponsor
R-Pharm International, LLCBarnaul
Recruiting
A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - aBC in Routine Clinical Practice in the Russia
Patients with HR+HER2- advanced breast cancer that initiated treatment with ribociclib+ET or combination CT will be enrolled. Approximately, 188 patients will be included into each treatment cohort of the study across different study sites in the Russian Federation and will be assigned to one of the below treatment arms: - Ribociclib arm: ribociclib (600 mg, 3 weeks on/1 week off)+ IA/FUL + goserilin for premenopausal patients (N = 188) - Combination chemotherapy arm: physician's choice (N = 188) The study will consist of pre-index period, index date and follow up period. Retrospective data will be collected as such: Medical history, previous treatment for Breast cancer (neoad'uvant and ad'uvant if applicable).In this study an index date is defined as a start of ribociclib+ET or chemotherapy treatment. Post-index follow-up period is 24 months or Progressive disease. Patients will attend 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. No additional diagnostic or monitoring procedures will be applied to the patients and epidemiological methods shall be used for the analysis of collected data. 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.
Phase
N/ASpan
183 weeksSponsor
Novartis PharmaceuticalsBarnaul
Recruiting
Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®
Adalimumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Humira®, which is approved as treatment in patients with chronic plaque psoriasis. This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.
Phase
3Span
118 weeksSponsor
Mabscale, LLCBarnaul
Recruiting
Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice
Phase
N/ASpan
161 weeksSponsor
POLYSAN Scientific & Technological Pharmaceutical CompanyBarnaul
Recruiting
HER2-low Unresectable and/or Metastatic Breast Cancer in Russia
Phase
N/ASpan
96 weeksSponsor
AstraZenecaBarnaul
Recruiting
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.
Phase
N/ASpan
205 weeksSponsor
Novartis PharmaceuticalsBarnaul
Recruiting