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Pegsunercept

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Amgen Inc.|Last Updated: Mar 6, 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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment216
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00111423Evaluating the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI)in Subjects With Rheumatoid Arthritis (RA)PHASE2 COMPLETED 216Aug 1, 2002 -Mar 6, 2009 -
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Study Endpoints
Primary Endpoints
Treatment-emergent adverse events
Secondary Endpoints
Description of RA assessment outcomes
Assessment of Compliance
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Pegsunercept (PEG sTNF-RI)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: - Subjects who have completed 24 weeks of double-blind treatment in a previous protocol (20000201 or 20000198) - Females of childbearing potential and males must practice adequate contraception, in the judgement of the investigator, during the course of the study - The subject or...

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