Tula, Russian Federation Clinical Trials

This is an event driven study to reach statistical power given all other assumptions. Subjects will visit the clinic 1 month after randomization and at regular intervals thereafter. Additionally, for any subject prematurely discontinuing study medication, assessments will be conducted every 6 months for the collection of study endpoints. Those ...

QUESTIONS AND OBJECTIVES OF ALL-MB 2015 STUDY Will the new risk group stratification (especially of T-ALL) to improve overall and event-free survival? Will the new protocol is effective and feasible in patients older than 15 years, and especially in young adults? Whether the intermittent dexamethasone administration in induction will result ...

Participants considered an adult according to local regulations at the time of signing informed consent will be randomized in a 1:1 ratio to receive ASP2215 or salvage chemotherapy. Participants will enter the screening period up to 14 days prior to the start of treatment. Prior to randomization, the investigator will ...

The registry intends to provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes and established micro- and/or macrovascular disease. Countries involved may vary depending on the interest shown by investigators and authorities all over the world

It is known that only 50% of patients with chronic diseases adhere to medical recommendations; at the same time, high patient adherence significantly improve the survival of patients with chronic diseases. The treatment duration required to achieve a significant reduction in the risk of cardiovascular complications is the subject of ...

The objective of this study is to access retention rate, persistence and adherence in population of spondylarthritis (SpA) (ankylosing spondylitis (AS) and psoriatic arthritis (PsA)) participants treated with adalimumab in routine clinical settings in the Russian Federation.

The goal of this Phase III study is to assess the safety, tolerability, and efficacy of OKZ in subjects with moderately to severely active RA who have responded inadequately to MTX. The primary endpoint of the trial is at Week 12. Olokizumab is expected to reduce the disease activity and ...

In this study CKD patients on dialysis previously treated by short-acting epoetins will switch to one of darbepoetin alfa products - BCD-066 (experimental arm) or Aranesp (active comparator) to maintain previously achieved target level of hemoglobin (100-120 g/l). Patients will be treated for 52 weeks. IV iron supplementation will be ...

The purpose of this study is to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free ...

This international multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (NN: rituximab, CJSC Biocad) versus MabThera (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered as a monotherapy of patients with indolent non-Hodgkin's lymphoma. Patients will be randomized to receive 375 mg/m² BCD-020 ...