Tolerability and safety profile of 12- to 28-week treatment with interferon beta-1b 250 and 500 µg QOD in patients with relapsing-remitting multiple sclerosis: A multicenter, randomized, double-blind, parallel-group pilot study

Hurwitz, Barrie J.; Jeffery, Douglas; Arnason, Barry G. W.; Bigley, Kim; Coyle, Patricia K.; Goodin, Douglas S.; Kaba, Samer E.; Kirzinger, S; Lynch, Sharon G.; Mandler, Raúl N.; Mikol, Daniel D.; Rammohan, Kottil; Sater, Richard A.; Subramaniam, Sriram; Thrower, Ben; Boateng, Francis; Jakobs, Peter; Wash, Mary Beth; Bogumil, Timon

doi:10.1016/j.clinthera.2008.06.013

Cited by 13 publications

(7 citation statements)

References 16 publications

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“…Although this study showed that the higher dose was well tolerated, the clinical effi cacy was not assessed. 2 Multiple sclerosis is characterised by recurrent clinical and subclinical disease activity. Interferon beta-1b reduces the number and volume of gadolinium-enhancing 3 and T2-weighted lesions.…”

Section: Introductionmentioning

confidence: 99%

250 μg or 500 μg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study

O’Connor¹,

Filippi²,

Arnason³

et al. 2009

The Lancet Neurology

387

280

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Section: Introductionmentioning

confidence: 99%

250 μg or 500 μg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study

O’Connor¹,

Filippi²,

Arnason³

et al. 2009

The Lancet Neurology

387

280

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“…This observation may also partially explain the lack of clear benefit associated with the use of IFN-α2a, IFN-α2b or IFN-β1a in combination with ribavirin. Recombinant IFN-β1b (Betaseron®, Bayer, Leverkusen, Germany) is approved for multiple sclerosis [17][18][19].…”

Section: Introductionmentioning

confidence: 99%

Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial

Arabi

Alothman

Balkhy

et al. 2018

Trials

267

226

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BackgroundIt had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission.MethodsThe protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality.DiscussionThis will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018.Trial registrationClinicalTrials.gov, ID: NCT02845843. Registered on 27 July 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2427-0) contains supplementary material, which is available to authorized users.

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“…A more recent study assessed whether a further twofold dose increase would have an acceptable tolerability profile and might provide additional benefits. Two formulations of IFNb-1b were evaluated in a multicenter, randomized, double-blind, dose-comparison study [Hurwitz et al 2008]. Patients received either 250 or 500 mg of SC IFNb-1b for !12 weeks.…”

Section: Dose Comparison Trials: Does Dose Matter?mentioning

confidence: 99%

The interferon beta therapies for treatment of relapsing–remitting multiple sclerosis: are they equally efficacious? A comparative review of open-label studies evaluating the efficacy, safety, or dosing of different interferon beta formulations alone or in combination

Limmroth¹,

Putzki

Kachuck

2011

Ther Adv Neurol Disord

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Interferon beta preparations are the most widely used initial therapies prescribed for patients with relapsingremitting multiple sclerosis. Phase III studies have demonstrated comparable efficacy on clinical measures of disease activity, variable benefits on radiological measures, and good overall tolerability. Subsequent clinical studies have attempted to compare directly the three available interferon beta preparations, reporting both safety and efficacy data. We review the literature on studies evaluating interferon beta therapy for patients with relapsingremitting multiple sclerosis, discuss reasons for discrepant findings, and assess the utility of interferon beta-based combination regimens as the focus of future studies in the increasingly complex multiple sclerosis therapy landscape.

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Tolerability and safety profile of 12- to 28-week treatment with interferon beta-1b 250 and 500 µg QOD in patients with relapsing-remitting multiple sclerosis: A multicenter, randomized, double-blind, parallel-group pilot study

Cited by 13 publications

References 16 publications

250 μg or 500 μg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study

250 μg or 500 μg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study

Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial

The interferon beta therapies for treatment of relapsing–remitting multiple sclerosis: are they equally efficacious? A comparative review of open-label studies evaluating the efficacy, safety, or dosing of different interferon beta formulations alone or in combination

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