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AMG 108

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Amgen Inc.|Last Updated: Dec 13, 2016

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-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment1,503
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00369473Long-Term Assessment of Safety and Physical Function With AMG 108 in RAPHASE2 COMPLETED 690Sep 1, 2006Jun 1, 2008Dec 13, 2016 -
NCT00293826A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid ArthritisPHASE2 COMPLETED 813Mar 1, 2006Feb 1, 2008Mar 5, 2010 -
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Study Endpoints
Primary Endpoints
To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168
144 Weeks
ACR20 response
24 Weeks
Secondary Endpoints
To determine whether long-term use of AMG 108 improves function in subjects with RA
144 Weeks
Change in subject reported outcomes
24 Weeks
ACRn, AUC ACRn, ACR50, ACR70, and DAS28
24 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL350
2EXPERIMENTAL350
3EXPERIMENTAL196 subjects
4PLACEBO_COMPARATOR196 subjects
Interventions
NameTypeDescription
AMG 108DRUG125 mg via SC (subcutaneous) injection every 4 weeks
PlaceboDRUGPlacebo via SC (subcutaneous) injection every 4 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll. Exclusion Criteria: * Subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.

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