A randomized, double-blind, placebo-controlled, parallel group, multi-centre Phase IIa study in asthma patients comparing the efficacy and safety of once daily inhaled Interferon beta-1a to placebo, administered for 14 days after the onset of symptoms of an upper respiratory tract infection for the prevention of severe exacerbations - INEXAS

开始日期2015-10-15

申办/合作机构

AstraZeneca AB

NCT02517788

/ Completed临床1期IIT

Comparative Pharmacokinetic Profile of Interferon Beta-1a (Bioferon®) Administered as Single i.v. Doses in HSA-free Formulation and HSA+ Solution and as Multiple s.c. Doses in Healthy Subjects

Phase I study aiming at:
establishing the pharmacokinetic profile of interferon beta-1a after i.v. administration of the formulation BioPartners IFN beta-1a without albumin (HSA-free solution in pre-filled syringes) at 18 MIU;
investigating the possible impact of albumin on pharmacokinetic profile by comparing 3 different i.v. formulations: BioPartners IFN beta-1a without albumin (HSA-free solution in pre-filled syringes), BioPartners IFN beta-1a with added albumin (HSA+), and Rebif® from Merck-Serono, a registered IFN beta-1a solution containing HSA;
establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in HSA-free solution after 4 subsequent s.c. doses of 18 MIU given at 48 hour intervals against Rebif® using the same regimen.

开始日期2006-05-01

申办/合作机构

Centre Hospitalier Universitaire Vaudois

[+1]

100 项与 Interferon beta-1a(Rentschler) 相关的临床结果

登录后查看更多信息

100 项与 Interferon beta-1a(Rentschler) 相关的转化医学

登录后查看更多信息

100 项与 Interferon beta-1a(Rentschler) 相关的专利（医药）

登录后查看更多信息

项与 Interferon beta-1a(Rentschler) 相关的文献（医药）

2024-10-01·Multiple Sclerosis and Related Disorders

Efficacy and safety of peginterferon beta-1a compared to interferon beta-1a in relapsing remitting multiple sclerosis patients: A phase 3, randomized, non-inferiority clinical trial (PEGINTEGRITY)

Article

作者: Ashtari, Fereshteh ; Saeidi, Morteza ; Shaygannejad, Vahid ; Abolfazli, Roya ; Ayromlou, Hormoz ; Baghbanian, Seyed Mohammad ; Asadollahzadeh, Elnaz ; Beladi Moghadam, Nahid ; Sabzvari, Araz ; Ghiasian, Masoud ; Ghalyanchi Langroodi, Hamidreza ; Azimi Saeen, Amirreza ; Kafi, Hamidreza

BACKGROUNDMultiple sclerosis (MS) is a prevalent, disabling, inflammatory, neurodegenerative disease that typically manifests during a highly productive stage of life. Interferon beta-1a was among the first approved disease-modifying therapies for MS and remains among the first-line treatment options. Pegylation of the interferon beta-1a molecule prolongs its half-life while maintaining its efficacy and safety profile. In PEGINTEGRITY study, we aimed to compare peginterferon beta-1a with interferon beta-1a in terms of efficacy and safety in relapsing-remitting multiple sclerosis (RRMS) patients.METHODSThis study was a randomized, active-controlled, parallel-group, multi-center Phase 3 trial conducted in Iran in participants with RRMS. Participants received 125 µg of subcutaneous peginterferon beta-1a every two weeks or 30 µg of intramuscular interferon beta-1a once a week for up to 96 weeks. The primary outcome was the non-inferiority of peginterferon beta-1a to interferon beta-1a in reducing annualized relapse rate (ARR). Other outcomes included the number of patients with 12-week confirmed disability progression, the number of new or newly-enlarging T2 hyperintense lesions, the number of gadolinium-enhancing lesions, the number of new T1 hypointense lesions, the volume of new or newly-enlarging T2 hyperintense lesions, changes in brain volume, immunogenicity, and safety assessments.RESULTSA total of 168 patients who met the eligibility criteria were enrolled and assigned to two arms of the study, each consisting of 84 participants. Totally, 41 participants (24 patients in the peginterferon beta-1a group and 17 patients in the interferon beta-1a group) were withdrawn from the study. The withdrawn patients were included in the per-protocol analysis for the period of time they were in the study. In 96 weeks, in the per-protocol population, the ARR was 0.05 in the peginterferon beta-1a group versus 0.11 in the interferon beta-1a group, which does not reflect a statistically significant difference (p=0.09; 95 % CI, 0.18-1.14). Considering the upper limit of the one-sided 95 % CI of the rate ratio of peginterferon beta-1a compared to interferon beta-1a, as well as the non-inferiority margin, it can be concluded that the primary outcome was met. The results were also comparable for other efficacy and safety outcomes.CONCLUSIONThe results demonstrate the non-inferiority of peginterferon beta-1a to interferon beta-1a with similar efficacy in 96-week ARR in RRMS patients. Both arms were also comparable in other efficacy outcomes and safety profiles with no statistically significant differences. These findings support considering peginterferon beta-1a as a safe and efficient option in patients with RRMS. This study was registered on Iranian Registry of Clinical Trials (IRCT201612306135N8) and clinicaltrials.gov (NCT05242133).

2024-08-01·Inflammopharmacology

Surveying haemoperfusion impact on COVID-19 from machine learning using Shapley values

Article

作者: Beyram, Bentolhoda ; Ebrahimi, Mehrdad ; Kianfar, Ehsan ; Javanbakht, Mohammad ; Ghasemi, Sholeh ; Ahmadi, Mohammad ; Mirani, Abolfazl ; Einollahi, Zahra ; Einollahi, Behzad ; Izadi, Morteza

BACKGROUNDHaemoperfusion (HP) is an innovative extracorporeal therapy that utilizes special cartridges to filter the blood, effectively removing pro-inflammatory cytokines, toxins, and pathogens in COVID-19 patients. This retrospective cohort study aimed to assess the clinical benefits of HP for severe COVID-19 cases using Shapley values for machine learning models.METHODSThe research involved 578 inpatients (≥ 20 years old) admitted to Baqiyatallah hospital (Tehran, Iran). The control group (359 patients) received standard treatment, including high doses of corticosteroids (a single 500 mg methylprednisolone pulse, followed by 250 mg for 2 days), categorized as regimen (I). On the other hand, the HP group (219 patients) received regimen II, consisting of the same corticosteroid treatment (regimen I) along with haemoperfusion using Cytosorb H300. The frequency of haemoperfusion sessions varied based on the type of lung involvement determined by chest CT scans. In addition, the value function __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__v defines the Shapley value of the __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__i th feature for the query point __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__x , where the input matrix features represent individual characteristics, drugs, and history and clinical conditions of the patient.RESULTSOur data showed a favorable clinical response in the HP group compared to the control group. Notably, one-to-three sessions of HP using the CytoSorb^® 300 cartridge led to reduced ventilation requirements and mortality rates in severe COVID-19 patients. Shapley values were calculated to evaluate the contribution of haemoperfusion among other factors, such as side effects, medications, and individual characteristics, to COVID-19 patient outcomes. In addition, there is a significant difference between the two groups among the treatments and medications used remdesivir, adalimumab, tocilizumab, favipiravir, Interferon beta-1a, enoxaparin prophylaxis, enoxaparin full dose, heparin prophylaxis, and heparin full dose (P < 0.05). It seems that haemoperfusion has a positive impact on the reduction of inflammation markers and renal functional such as ferritin and creatinine, respectively, as well as D-dimer and WBC levels in the HP group were significantly lower than the control group.CONCLUSIONThe findings indicated that haemoperfusion played a crucial role in predicting patient survival, making it a significant feature in classifying patients' prognoses.

2024-04-01·Multiple Sclerosis Journal - Experimental, Translational and Clinical

Safety and clinical effectiveness of peginterferon beta-1a for relapsing multiple sclerosis in a real-world setting: Final results from the Plegridy Observational Program

Article

作者: Kumar, Achint ; Salvetti, Marco ; Nelles, Gereon ; Vignos, Megan ; Koster, Thijs ; Belviso, Nicholas ; Wray, Sibyl ; Castro-Borrero, Wanda

Background Interferon beta-1a remains an important treatment option for multiple sclerosis, particularly when safety or tolerability concerns may outweigh the benefits of higher-efficacy disease-modifying therapies. The five-year phase 4 Plegridy Observational Program (POP) study (NCT02230969) collected data on real-world safety and effectiveness of Plegridy® (peginterferon beta-1a) treatment in patients with relapsing multiple sclerosis. Objective To explore the real-world safety and effectiveness of peginterferon beta-1a in patients with relapsing multiple sclerosis, including factors influencing treatment discontinuation. Methods Data were collected prospectively from patients ≥ 18 years old with relapsing multiple sclerosis for overall population analysis and for subpopulations including newly/previously diagnosed patients, age, and experience with peginterferon beta-1a. Outcome measures included annualized relapse rates, adverse events, and predictors of time to treatment discontinuation. Results Mean (SD) treatment duration in the overall population ( N = 1172) was 896.0 (733.15) days. Incidence of adverse events was higher in new than experienced users (79.4% vs. 57.0%). New users were more likely than experienced users to discontinue (hazard ratio = 1.60; P < 0.0001). The adjusted annualized relapse rate was 0.09, and at the end of 5 years, 77.1% of patients were relapse-free. Conclusions Peginterferon beta-1a is an effective therapy for managing relapsing multiple sclerosis. The identification of predictors of discontinuation can help inform strategies to enhance treatment persistence.

项与 Interferon beta-1a(Rentschler) 相关的新闻（医药）

2009-02-20

·Pharma Times

EMEA calls for Raptiva suspension, issues latest recommendations

On a busy day for the regulator, the European Medicines Agency has recommended that marketing authorisation be suspended for Merck KGaA/Genentech's psoriasis drug Raptiva over possible links between the drug and a rare but deadly brain infection. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) said the benefits of Raptiva (efalizumab) no longer outweigh its risks, because of safety concerns, notably the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine. The CHMP noted three confirmed cases of PML in patients who had taken Raptiva for more than three years, two of resulted in the patient’s death, and the agency has received an additional report of a suspected case of PML, “which could not be confirmed”. Nevertheless, following a review, the CHMP has concluded that “Raptiva’s benefits are modest”. In addition to PML, Raptiva is associated with other serious side effects, including Guillain-Barre and Miller-Fisher syndromes, encephalitis, encephalopathy, meningitis, sepsis and opportunistic infections,” the EMEA noted. It added that “there is not enough evidence to identify a group of patients in which the benefits of Raptiva outweigh its risks”. The EMEA’s call for suspension came as its counterpart in the USA, the Food and Drug Administration, issued a public health advisory about the three confirmed reports of PML and the possible fourth case. The FDA stated that it will “take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits”. Merck, which markets Raptiva in Europe, said it would work with health authorities across the continent "to undertake all necessary measures to comply with the EMEA recommendations." Earlier this week, the Darmstadt-based group noted that it had written off 195 million euros due to “sharply lower sales expectations” for the drug. Staying with the EMEA, the agency has issued the latest list of positive opinions from the CHMP. The drugs recommended for approval include Wyeth’s Conbriza (bazedoxifene) for postmenopausal osteoporosis, Bial’s anti-epileptic Zebinix (eslicarbazepine; see story on today’s elert) and Fresenius’ Removab (catumaxomab) for the removal of cancerous fluid from the abdomen. The CHMP is also recommending approval for Nycomed’s over-the-counter versions of its own heartburn drug Pantozol (pantoprazole) and Teva’s generic version of Novartis’ anti-dementia drug Exelon (rivastigmine). However, it adopted a negative opinion for Biferonex (interferon-beta-1a), from Switzerland’s BioPartners, for multiple sclerosis. BioPartners is appealing the decsion, claiming that Biferonex demonstrated safety and efficacy profiles comparable to established interferon beta-1a products already on the market".

100 项与 Interferon beta-1a(Rentschler) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D04554	Interferon beta-1a(Rentschler)	-	DB00060

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
多发性硬化症	临床3期	-	Rentschler Biotechnologie GmbH	-
多发性硬化症	临床3期	-	Biopartners GmbH	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


German Multiple Sclerosis and Pregnancy Registry (ECTRIMS2023)	N/A	多发性硬化症	247	Interferon beta-1a	(鑰窪簾製蓋鏇醖艱窪構) = comparable between exposed children and controls during the observation period 觸網鬱構築壓淵遞獵選 (齋壓襯遞積憲餘淵鹹廠 ) 更多	积极	2023-09-30
ECTRIMS2023	N/A	一线	560	Interferon beta-1a	鹹遞遞選觸糧壓夢鏇鏇(齋廠鹽鑰鹹選觸顧窪衊) = 範構範淵襯憲鏇鬱襯膚構遞夢獵夢憲艱觸構淵 (鏇壓遞願糧憲壓蓋窪範 )	-	2023-09-30
ACTRIMS2023	N/A	多发性硬化症	-	Interferon beta-1a	願簾簾膚淵鏇繭膚鑰遞(鏇蓋襯衊餘齋顧積鏇醖) = congestive heart failure 鑰願積鑰憲餘繭獵選構 (鬱膚構鏇壓壓構鬱選膚 ) 更多	不佳	2023-05-30
P15-4.009 (AAN2022)	N/A	复发-缓解型多发性硬化	400	Interferon beta-1a	壓餘繭襯鹹範獵簾網憲(襯願範鬱襯製憲範衊顧) = 鑰壓範鑰鹽襯鹽願鬱簾餘繭簾遞鹹顧繭醖齋蓋 (鹽淵齋鹽繭簾積顧製鑰 ) 更多	-	2022-05-03
ACTRIMS2017	N/A	复发性多发性硬化	-	Ocrelizumab 600 mg every 24 weeks	(醖簾鹹醖簾選遞範網繭) = 繭艱蓋觸襯壓簾製鑰蓋夢淵鹽築築艱積醖簾餘 (憲繭蓋齋鏇襯鏇夢餘鹽 )	-	2017-02-01
ACTRIMS2017	N/A	复发性多发性硬化	-	Interferon beta-1a 44 Î¼g 3 times weekly	(醖簾鹹醖簾選遞範網繭) = 獵積醖築願鏇窪鏇襯觸夢淵鹽築築艱積醖簾餘 (憲繭蓋齋鏇襯鏇夢餘鹽 )	-	2017-02-01