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Interferon beta-1a

Phase 3

Multiple Sclerosis | Small molecule | Neurology |Biogen Inc.|Last Updated: Mar 5, 2010

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment229

FDA Designations

No designations recorded

Clinical trial landscape

Interferon beta-1a · 3 trials · 2 indications

Phase 3 1Phase 2 2
NCT00915577Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex SyringeMultiple Sclerosis
COMPLETED74 Analytics
PHASE3COMPLETED
Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringe
The study duration is 8 Weeks
The primary endpoint for the efficacy analyses is the total IVIg dose (g/Kg) administered after Visit 5 and through Visit 9 (Week 32, End of Study).
To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX®
Study duration is 20 months

Secondary Endpoints

The time to disease progression.
Percentage reduction in IVIg dose (g/Kg).
The number of days between Visit 5 and either disease progression or Visit 9
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Study Design & Arms

MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1st InjectionEXPERIMENTALManual injection with pre-filled syringe.
Single-use autoinjectorEXPERIMENTALSingle-use autoinjector with Avonex pre-filled syringe
1EXPERIMENTALserum-free avonex given IM

Interventions

NameTypeDescription
Interferon beta-1aDRUG30mcg, IM once-a-week
Single-use autoinjectorDEVICESingle-use autoinjector with Avonex 30mcg pre-filled syringe
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Must be using liquid AVONEX® to treat MS. In addition, the subject must be on liquid AVONEX® for 12 weeks prior to the Screening Visit. * Must have a BMI of 19 to 28 kg/m², inclusive, and a minimum body weight of 50 kg at Screening. * Must be able to physically demonstrate use...

Countries:United StatesAustraliaCanadaUnited Kingdom
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Frequently asked questions about Interferon beta-1a

What is Interferon Beta-1a used for?

Interferon Beta-1a is used for the treatment of Multiple Sclerosis (MS) and Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). It is being developed by Biogen Inc. (BIIB) and is currently in Phase 2 clinical trials for these neurological conditions.

What does Interferon Beta-1a target?

Interferon Beta-1a is a small molecule that works by modulating the immune system to reduce inflammation in the central nervous system. It is specifically used to treat autoimmune conditions like Multiple Sclerosis and Chronic Inflammatory Demyelinating Polyradiculoneuropathy by altering the body's immune response.

Who makes Interferon Beta-1a?

Interferon Beta-1a is developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen is conducting clinical trials to evaluate the drug's safety and efficacy in treating Multiple Sclerosis and Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

What phase is Interferon Beta-1a in?

Interferon Beta-1a is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by the FDA. The drug is being studied for its potential to treat Multiple Sclerosis and Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

What clinical trials is Interferon Beta-1a in?

Interferon Beta-1a has completed two Phase 2 clinical trials. The first trial (NCT00099489) studied the drug in 67 patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy. The second trial (NCT00912860) evaluated immunogenicity and safety in 155 patients with Multiple Sclerosis.

Is Interferon Beta-1a the same as Avonex?

Yes, Interferon Beta-1a is the same as Avonex. Clinical trials for this drug include studies of Avonex in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Multiple Sclerosis, as well as studies of serum-free Avonex and a single-use autoinjector for delivering pre-filled Avonex syringes.