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

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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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126

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

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 ; Tacconelli, Evelina ; Delmas, Christelle ; 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.

2023-02-01·Multiple Sclerosis and Related Disorders

Interferon β1a treatment does not influence serum Epstein-Barr virus antibodies in patients with multiple sclerosis

Letter

作者: Rød, Brit Ellen ; Kvistad, Silje Stokke ; Lie, Ingrid Anne ; Torkildsen, Øivind ; Holmøy, Trygve ; Wergeland, Stig ; Myhr, Kjell-Morten

There is increasing evidence of Epstein-Barr virus (EBV) being conditional in multiple sclerosis (MS) pathogenesis and influential for disease activity. Interferon-beta (IFNβ) is a cytokine with antiviral effects used to treat MS, in which a possible antiviral effect against EBV has been questioned. In this study, we investigated the effect of IFNβ-1a treatment on serum EBV antibody levels in 84 patients with relapsing-remitting MS. In the 18 months following IFNβ-1a treatment initiation, there were no significant associations between treatment and serum levels of Epstein-Barr nuclear antigen 1 (EBNA-1) immunoglobulin (Ig) G, early antigen (EA) IgG, viral capsid antigen (VCA) IgG or VCA IgM. The findings suggest that IFNβ-1a treatment does not influence the humoral response to EBV in patients with MS.

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AB07	DB00060

研发状态

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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

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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	临床1期	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)	遞壓築簾構壓憲鑰範製(鹹壓艱齋餘壓構餘糧夢) = 艱鹹繭壓淵壓構廠醖廠廠鹹鬱蓋襯膚選鑰顧夢 (顧淵築糧醖遞淵餘夢遞, 窪願齋獵襯艱鬱觸淵築 ~ 淵遞願鏇艱積網窪蓋顧) 更多	-	2023-02-17
				Rebif (interferon beta 1a) (Rebif)	遞壓築簾構壓憲鑰範製(鹹壓艱齋餘壓構餘糧夢) = 構簾積憲顧積遞艱構膚廠鹹鬱蓋襯膚選鑰顧夢 (顧淵築糧醖遞淵餘夢遞, 壓齋蓋遞糧顧窪齋餘構 ~ 觸簾網襯衊廠獵簾艱構) 更多