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Enbrel

Phase 3

Ankylosing Spondylitis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Dec 13, 2007

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment234
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00434044Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing SpondylitisPHASE3 COMPLETED 150Feb 1, 2007Jun 1, 2007Dec 13, 2007 -
NCT00421915Study Evaluating Etanercept Treatment of Patients With Ankylosing SpondylitisPHASE3 COMPLETED 84Mar 1, 2002Aug 1, 2002Jan 15, 2007 -
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Study Endpoints
Primary Endpoints
Assessment in Ankylosing Spondylitis (ASAS) response criteria 20% at week six.
To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the
percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.
Secondary Endpoints
ASAS 20% response at all visits except week two. ASAS 50%, 70%, 40%, 5/6 responses at all visits.
To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept
compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Enbrel (etanercept)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Must be of Chinese ancestry and living in China. 2. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis. 3. Active AS at time of enrollment, defined by average of visual analog scale (VAS) values for duration and intensity of morning stiffness...

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Competitive Landscape -Ankylosing Spondylitis 11 trials