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TMI-005

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Sep 10, 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 Trials1
Total Enrollment390
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00095342Study Evaluating TMI-005 in Active Rheumatoid ArthritisPHASE2 COMPLETED 390 -Aug 1, 2005Sep 10, 20098 United States, Canada
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
TMI-005DRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Meet American College of Rheumatology (ACR) criteria for RA * Have active RA * Disease duration of at least 6 months * Disease onset at \> 16 years of age. Exclusion Criteria: * Any prior use of anti-TNF alpha biologics, rituximab, receipt of anti-CD4 or diphtheria interleuk...

Countries:United StatesCanada
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