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Intra-articular metHuIL-1ra

Phase 2

Osteoarthritis | Small molecule | Musculoskeletal |Amgen Inc.|Last Updated: Feb 22, 2008

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 Enrollment165
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00110916Treatment for Patients With Osteoarthritis (OA) of the KneePHASE2 COMPLETED 165Jun 1, 2004Feb 1, 2005Feb 22, 2008 -
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Study Endpoints
Primary Endpoints
WOMAC
12 weeks
Secondary Endpoints
Pain Patient's global assessment
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AnakinraEXPERIMENTALanakinra
placeboPLACEBO_COMPARATORplacebo
Interventions
NameTypeDescription
Intra-articular metHuIL-1ra (anakinra)DRUGanakinra
placeboDRUGplacebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: - Diagnosed with knee OA as determined by American College of Rheumatology (ACR) criteria - Pain defined by a level of greater than 30 mm on a 100 mm Visual Analogue Scale (VAS) - No evidence of active effusion or inflammatory flare, confirmed by investigator - Must exhibit radio...

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