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BMS-817399

Phase 2

Rheumatoid Arthritis | 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 Enrollment123
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01404585Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid ArthritisPHASE2 COMPLETED 123Sep 1, 2011Feb 1, 2013Oct 12, 201529 United States, Argentina +5
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Study Endpoints
Primary Endpoints
Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) change from baseline of BMS-817399 versus placebo
Baseline and at 12 weeks
Secondary Endpoints
Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests
16 weeks
Proportion of subjects achieving 20% American College of Rheumatology (ACR) response in each treatment group
Day 15
Proportion of subjects achieving 20% ACR response in each treatment group
Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: PlaceboPLACEBO_COMPARATOR -
Arm 2: BMS-817399 (200 mg)EXPERIMENTAL -
Arm 3: BMS-817399 (400 mg)EXPERIMENTAL -
Interventions
NameTypeDescription
PlaceboDRUGTablets, Oral, 0 mg, twice daily, 12 weeks
BMS-817399DRUGTablets, Oral, 200 mg, twice daily, 12 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Male or female subjects, 18 years of age or older, with rheumatoid arthritis (RA) for at least 6 months prior to screening * Subjects must have a tender joint count of at least 6 (28 joint count), swollen joint count of at least 6 (28 joint count) at screening. All subjects mu...

Countries:United StatesArgentinaMexicoRussiaSouth AfricaSouth KoreaSpain
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