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GW274150

Phase 2

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |GSK plc|Last Updated: May 30, 2017

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 Trials2
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00379990A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.PHASE2 COMPLETED 48Jan 1, 2006Dec 1, 2007Jul 2, 20122 Serbia, United Kingdom
NCT00370435Study Of 90mg Of GW274150 In Subjects Over 50 Years, Who Have Rheumatoid Arthritis (RA)PHASE2 COMPLETED 6Aug 1, 2005Sep 1, 2005May 30, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Measurment of synovial vascularity
Day 1, Day 15 and Day 28

Power Doppler ultrasonographic measurement of synovial vascularity

Liver function and creatinine clearance after single 90mg dose of GW274150
Secondary Endpoints
Synovial thickness
Day 1, 15 and 28
Safety: ECG
Day 1, 15 and 28
Safety: Vital Signs
Day 1, 15 and 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GW274150 60 mg once daily for 28 daysEXPERIMENTAL60 mg GW274150 taken once daily for 28 days
Prednisolone 7.5 mg once daily for 28 daysACTIVE_COMPARATOR7.5 mg prednisolone taken once daily for 28 days
Placebo once daily for 28 daysPLACEBO_COMPARATORPlacebo taken once daily for 28 days
Interventions
NameTypeDescription
GW274150DRUG60 mg /day
PrednisoloneDRUG7.5 mg/day
PlaceboOTHERPlacebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: * Diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology * Female subjects who are not capable of becoming pregnant * Active disease defined as Disease Activity Score (DAS) 28 = 4.0 and at least one metacarpal-phalangeal ...

Countries:SerbiaUnited Kingdom
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