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anakinra

Phase 3

Rheumatoid Arthritis | Small molecule | Immunology |Amgen Inc.|Last Updated: Nov 26, 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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00117091Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)PHASE3 COMPLETED - - -Dec 24, 2007 -
NCT00037700Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid ArthritisPHASE2 COMPLETED -May 1, 2001Dec 1, 2002Nov 26, 2009 -
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Study Endpoints
Primary Endpoints
% of subjects continuing Kineret® therapy at the end of the study (I.e., responders according to pre-defined response assessment criteria.)
Secondary Endpoints
Change in Health Related Quality of Life (HRQOL) scores at the end of study weeks 12, 24, 36 and 48.
feasibility of simpleject device
treatment response (ACR scores, DAS 28) at the end of study weeks 12, 24, 36 and 48.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Anakinra (Kineret®)DRUG -
anakinraDRUG -
pegsunerceptDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: - Subjects diagnosed with RA as determined by American College of Rheumatology (ACR) criteria with a disease duration of at least 24 weeks prior to enrollment - Active RA at screening as defined by EITHER: (1) At least 6 swollen joints (using a 66 joint count) and at least 6 tend...

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