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Human anti-TNF monoclonal antibody/adalimumab

Phase 3

Psoriatic Arthritis | Monoclonal antibody | Other |Abbott Laboratories|Last Updated: Aug 29, 2007

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
UNCONTROLLED
Total Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00195689Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic ArthritisPHASE3 COMPLETED 400Aug 1, 2003 -Aug 29, 20071 United States
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Study Endpoints
Primary Endpoints
Safety parameters
ACR 20/50/70
PsARC
HAQ
SF-36
FACTIT Fatigue Scale
Disease progression measurements
Secondary Endpoints
Patient reported outcomes
Clinical response indicators
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Human anti-TNF monoclonal antibody/adalimumabBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject completed study M02-518 or M02-570 Exclusion Criteria: * Subject prematurely discontinued study M02-518 or M02-570 * Female subject who is pregnant or breast-feeding or considering becoming pregnant * Subject considered by the investigator, for any reason, to be...

Countries:United States
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