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BMS-582949

Phase 2

Rheumatoid Arthritis, NOS | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Oct 12, 2015

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment121
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00605735PoC in Rheumatoid Arthritis With MethotrexatePHASE2 COMPLETED 121Mar 1, 2008Sep 1, 2009Oct 12, 201528 United States, Argentina +6
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Study Endpoints
Primary Endpoints
The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12
at Week 12
Secondary Endpoints
Proportion of subjects achieving an ACR 20
at each scheduled visit
Proportion of subjects schieving and ACR 50
at each scheduled visit
Proportion of subjects schieving and ACR 70
at each scheduled visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A1EXPERIMENTAL -
P1PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BMS-582949DRUGTablets, Oral, 300 mg, once daily, 12 weeks
PlaceboDRUGTablets, Oral, placebo, once daily, 12 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Must have a diagnosis of RA for at least 6 months * Must be taking methotrexate for at least 3 months \& on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication * Must have at least 6 swollen and at least 8 tender joints * CRP above upper limit of...

Countries:United StatesArgentinaCzechiaFranceMexicoSouth KoreaSpainTaiwan
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