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PLA-695

Phase 1

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Dec 13, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00440492Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid ArthritisPHASE1 COMPLETED -Dec 1, 2006Nov 1, 2007Dec 13, 20079 United States, Canada
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Study Endpoints
Primary Endpoints
To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
PLA-695DRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Men or women of nonchildbearing potential with rheumatoid arthritis (RA), aged 18 to 75 years * RA disease onset after 16 years of age and has had the disease for at least 6 months * Must be receiving a stable, well-tolerated oral dose of methotrexate (5 to 25 mg) taken once w...

Countries:United StatesCanada
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