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Enbrel , Etanercept

Phase 3

Psoriasis | Unknown | Immunology |Pfizer, Inc.|Last Updated: Mar 30, 2012

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment421
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00482170Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for EtanerceptPHASE3 COMPLETED 421Sep 1, 2007Sep 1, 2009Mar 30, 201278 Belgium, Denmark +10
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Study Endpoints
Primary Endpoints
Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population
Week 12

Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.

Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population
Week 12

Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.

Secondary Endpoints
Percentage of Participants Satisfied With Injection Device
Baseline, Week 4 and Week 12
Influence of Age on Participant Satisfaction With Injection Device
Week 12
Influence of Gender on Participant Satisfaction With Injection Device
Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALArm 1: Enbrel 50 mg Prefilled Syringe
2ACTIVE_COMPARATORArm 2 Enbrel 50 mg Autoinjector
Interventions
NameTypeDescription
Enbrel (etanercept)DEVICEArm 1 = Enbrel 50 mg Prefilled Syringe twice weekly
EtanerceptDEVICEArm 2 = Enbrel 50 mg Autoinjector twice weekly
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites78

Inclusion Criteria: * Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA * Eligible for treatment with etanercept according to Summary of P...

Countries:BelgiumDenmarkFinlandFranceGermanyGreeceHungaryItalyNetherlandsNorwaySpainSweden
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