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Enbrel liquid

Phase 3

Rheumatoid Arthritis | Small molecule | Immunology |Amgen Inc.|Last Updated: Jul 30, 2010

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
UNCONTROLLED
Total Trials1
Total Enrollment447
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00249041Enbrel Liquid Immunogenicity ProtocolPHASE3 COMPLETED 447Oct 1, 2005Mar 1, 2007Jul 30, 2010 -
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Study Endpoints
Primary Endpoints
Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24
24 weeks
Secondary Endpoints
Rates of anti-etanercept antibody formation to etanercept liquid at week 12, and the rates of neutralizing antibodies at Weeks 12 and 24. Safety of etanercept liquid in RA subjects receiving 50 mg once weekly up to 24 weeks.
12 weeks and 24 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Etanercept liquidEXPERIMENTAL -
Interventions
NameTypeDescription
50 mg EtanerceptDRUG50 mg Etanercept liquid injected SC once weekly using prefilled syringes
Enbrel liquidDRUG50 mg Etanercept liquid injected SC once weekly using prefilled syringes
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 18 years of age or older * Must be able to self-inject or have someone who can do so for them * Should have Rheumatoid Arthritis per ARA criteria and screening lab results per predefined value Exclusion Criteria: * Any prior biologic therapy for inflammatory disease * Any pr...

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