International, Multicenter, Double-blinded, Placebo-controlled, Randomized Study of the Efficacy and Safety of Drugs BCD-033 and Rebif for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis

Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with the use of active comparator and placebo. Total duration of therapy of about 2 years. Study hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033 original drug Rebif®.

开始日期2015-02-12

申办/合作机构

Biocad CJSC

100 项与干扰素β-1a生物类似药(Biocad Medical, Inc.) 相关的临床结果

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100 项与干扰素β-1a生物类似药(Biocad Medical, Inc.) 相关的转化医学

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100 项与干扰素β-1a生物类似药(Biocad Medical, Inc.) 相关的专利（医药）

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项与干扰素β-1a生物类似药(Biocad Medical, Inc.) 相关的文献（医药）

2024-11-01·CNS Drugs

Ozanimod: A Review in Relapsing Forms of Multiple Sclerosis

Review

作者: Nie, Tina ; Syed, Yahiya Y ; Syed, Yahiya Y.

Ozanimod (Zeposia^®), an orally administered sphingosine 1-phosphate (S1P) receptor modulator (S1PRM) that is selective for the S1P₁ and S1P₅ receptor subtypes, is approved in the USA for relapsing forms of multiple sclerosis (RMS). In pivotal phase III clinical trials in patients with RMS, ozanimod significantly reduced annualised relapse rates and the number of new or enlarging T2 lesions and gadolinium-enhancing lesions, and was associated with reduced brain volume loss, compared with interferon (IFN)-β1a. However, there were no significant differences in 3- and 6-month disability progression between the groups. Ozanimod was generally well tolerated, with the most common adverse reactions including upper respiratory tract infection and hepatic transaminase elevation. Efficacy and tolerability were sustained over more than 6 years with continued treatment. S1PRM-related adverse events seen with ozanimod are generally manageable with screening and/or monitoring. Notably, ozanimod does not require first-dose cardiac monitoring in the USA. In conclusion, ozanimod is a valuable once-daily oral disease-modifying therapy that extends the available treatment options for patients with RMS.

2024-04-01·Acta Neurologica Belgica

Potential beneficial effect of IFN-β1a and ocrelizumab in people with MS during the COVID-19 pandemic

Article

作者: Danilović, Miloš ; Savić, Dejan ; Vojinović, Slobodan ; Todorović, Stefan ; Aleksić, Dejan

BACKGROUND/AIMDisease-modifying therapy (DMT) has led to added challenges in the management of people with multiple sclerosis (pwMS) during the COVID-19 era. It can reduce relapse in MS or slow down disease progression, but some DMTs can increased risk of infection. The aim of study was to evaluate risk and severity of COVID-19 in pwMS.METHODSThe examined group of pwMS were divided in group treated with IFN-β1a, group treated with ocrelizumab and untreated group. The examination included impact of age, gender, duration of MS, type of MS, vaccination status and Expanded Disability Status Scale (EDSS) on the risk and severity of COVID-19 infection. A diagnosis of COVID-19 in pwMS was confirmed by positive polymerase-chain-reaction (PCR) or antigen test.RESULTSOut of 207 pwMS, 82 patients were treated with ocrelizumab, 63 with IFN-β1a, while 62 patients were untreated pwMS. The average duration of the MS was longer in the group of patients treated with ocrelizumab than in the group treated with IFN-β1a (p < 0.05). EDSS was higher in the ocrelizumab group compared to the other two groups (p < 0.001). Untreated (more often unvaccinated) had the same COVID frequency as ocrelizumab-treated (more vaccinated, but higher EDSS). The multivariate logistic regression model indicated that administration of IFN-β1a reduces the risk of COVID-19 infection (p = 0.001, OR = 0.381, 95% CI 0.602-0.160). The use of both DMTs, driven mainly by the IFN-β1a effect, reduces the risk of moderate and severe COVID-19 (p < 0.05, OR = 0.105, 95% CI 0.011-0.968).CONCLUSIONThis study provides evidence that IFN-β1a can reduce the frequency of COVID-19 infection and that two DMTs, driven mainly by the IFN-β1a effect, do not increase the risk of moderate/severe COVID-19.

2023-06-01·Pharmacology research & perspectives

Management of pharmacovigilance during the COVID-19 pandemic crisis by the safety department of an academic sponsor: Lessons learnt and challenges from the EU DisCoVeRy clinical trial.

Review

作者: Espérou, Hélène ; Delmas, Christelle ; Tacconelli, Evelina ; Costagliola, Dominique ; Paiva, José Artur ; Poissy, Julien ; Greil, Richard ; Staub, Thérèse ; Saillard, Juliette ; Ader, Florence ; Dumousseaux, Marina ; Burdet, Charles ; Mentre, France ; Diallo, Alpha ; Fougerou-Leurent, Claire ; Belhadi, Drifa ; Le Mestre, Soizic ; Peiffer-Smadja, Nathan ; Ferrane, Assia ; Yazdanpanah, Yazdan ; Andrejak, Claire ; Hites, Maya ; Mercier, Noémie ; DeChanet, Aline

The current COVID-19 pandemic was an exceptional health situation, including for drug use. As there was no known effective drug for COVID-19 at the beginning of the pandemic, different drug candidates were proposed. In this article, we present the challenges for an academic Safety Department to manage the global safety of a European trial during the pandemic. The National Institute for Health and Medical Research (Inserm) conducted a European multicenter, open-label, randomized, controlled trial involving three repurposed and one-in development drugs (lopinavir/ritonavir, IFN-β1a, hydroxychloroquine, and remdesivir) in adults hospitalized with COVID-19. From 25 March 2020 to 29 May 2020, the Inserm Safety Department had to manage 585 Serious Adverse Events (SAEs) initial notification and 396 follow-up reports. The Inserm Safety Department's staff was mobilized to manage these SAEs and to report Expedited safety reports to the competent authorities within the legal timeframes. More than 500 queries were sent to the investigators due to a lack of or incoherent information on SAE forms. At the same time, the investigators were overwhelmed by the management of patients suffering from COVID-19 infection. These particular conditions of missing data and lack of accurate description of adverse events made evaluation of the SAEs very difficult, particularly the assessment of the causal role of each investigational medicinal product. In parallel, working difficulties were accentuated by the national lockdown, frequent IT tool dysfunctions, delayed implementation of monitoring and the absence of automatic alerts for SAE form modification. Although COVID-19 is a confounding factor per se, the delay in and quality of SAE form completion and the real-time medical analysis by the Inserm Safety Department were major issues in the quick identification of potential safety signals. To conduct a high-quality clinical trial and ensure patient safety, all stakeholders must take their roles and responsibilities.

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AB07	DB00060

研发状态

批准上市

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适应症	国家/地区	公司	日期
多发性硬化症	俄罗斯	Biocad Medical, Inc.	2017-01-01

未上市

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适应症	最高研发状态	国家/地区	公司	日期
复发-缓解型多发性硬化	药物发现	俄罗斯	Biocad CJSC	2015-02-12

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02727907 (CTgov)	临床2/3期	复发-缓解型多发性硬化	163	BCD-033 (interferon beta 1a) (BCD-033)	壓餘製鹽獵構憲廠襯齋(願鏇築鏇範衊艱鬱鹹壓) = 簾膚構鏇鬱鏇壓憲製窪觸醖顧遞簾鑰蓋糧夢艱 (選範襯蓋夢壓壓糧壓憲, 餘繭壓鬱鹽醖範餘淵遞 ~ 繭醖鬱鏇繭鹹網齋膚網) 更多	-	2023-02-17
				Rebif (interferon beta 1a) (Rebif)	壓餘製鹽獵構憲廠襯齋(願鏇築鏇範衊艱鬱鹹壓) = 簾範膚糧鹹襯糧齋齋壓觸醖顧遞簾鑰蓋糧夢艱 (選範襯蓋夢壓壓糧壓憲, 壓襯網蓋糧艱構膚遞糧 ~ 鏇遞窪餘夢衊鑰選廠鏇) 更多