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Interferon beta-1a

Phase 3

Multiple Sclerosis | Small molecule | Immunology |Biogen Inc.|Last Updated: Jun 10, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials2
Total Enrollment229
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00915577Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex SyringePHASE3 COMPLETED 74Aug 1, 2005Apr 1, 2006Jun 8, 2009 -
NCT00912860Immunogenicity and Safety Study of Serum-Free AvonexPHASE2 COMPLETED 155Jan 1, 2003Jan 1, 2005Jun 10, 2009 -
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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
To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX®
Study duration is 20 months
Secondary Endpoints
To evaluate the safety of a serum-free pre-formulated solution of AVONEX®
The study duration is 20 months
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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 — 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...

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