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GW406381

Phase 3

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |GSK plc|Last Updated: Mar 14, 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment2,208
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00113308COX-2 Inhibitor Study In Patients With Rheumatoid ArthritisPHASE3 COMPLETED 2,208 — — Jun 1, 2005Sep 1, 2006Mar 14, 2017341 United States, Argentina +31
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Study Endpoints
Primary Endpoints
Percentage of American College of Rheumatology (ACR)20 Responders at Week 12
Week 12
Secondary Endpoints
Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel)
Baseline and Week 12
Change from baseline to each scheduled visit in swollen joint count (66 joint panel)
Baseline and Week 12
Change from baseline to each scheduled visit in patient's pain assessment (VAS)
Baseline and Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
GW406381DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites341

Inclusion criteria: * Rheumatoid arthritis (RA) for at least 12 months. * Required a non-steroidal anti-inflammatory drug (NSAID) or COX-2 inhibitor for RA for at least 5 out of 7 days of each week for the 4 weeks prior to screening. Exclusion criteria: * Any history of cardiovascular disease (e....

Countries:United StatesArgentinaAustriaBelgiumBulgariaCanadaChileCosta RicaDenmarkFinlandFranceGermanyGreeceHungaryIndiaIrelandItalyLatviaMexicoNetherlandsNew ZealandNorwayPeruPhilippinesPolandPuerto RicoRomaniaRussiaSouth AfricaSouth KoreaSpainUkraineUnited Kingdom
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