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AMG 719

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Amgen Inc.|Last Updated: Jan 21, 2011

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00038298A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving MethotrexatePHASE2 COMPLETED 53Apr 1, 2002May 1, 2004Jan 21, 2011 -
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Study Endpoints
Primary Endpoints
AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.
Week 24
Secondary Endpoints
To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA
Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
50 mgEXPERIMENTAL50 mg 3 times weekly
400 mgEXPERIMENTAL400 mg 3 times weekly
200 mgEXPERIMENTAL200 mg 3 times weekly
PlaceboPLACEBO_COMPARATORPlacebo comparator associated with each active arm. (3:1 active vs placebo)
Interventions
NameTypeDescription
PlaceboDRUGPlacebo given 3 times weekly
AMG 719DRUG50 mg 3 times weekly
AGM 719DRUG200 mg 3 times weekly
placebo to AMG 719DRUGPlacebo dose given 3 times weekly
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

* Men or women, at least 18 years of age at screening * Diagnosed with Rheumatoid Arthritis, with a disease duration of at least 24 weeks, receiving methotrexate, and having no recent history of substance or alcohol abuse

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