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Rivaroxaban

Phase 3

Arthritis | Small molecule | Musculoskeletal |Johnson & Johnson|Last Updated: Mar 17, 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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01094886Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban After Orthopedic Surgery for Either Total Hip or Total Knee ReplacementPHASE3 COMPLETED 56Mar 1, 2010Dec 1, 2010Mar 17, 20175 United States
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Study Endpoints
Primary Endpoints
Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa)
Day 1, Day 3

Descriptive statistics for per-patient maximum Anti-Factor Xa laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3

Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time
Day 1, Day 3

Descriptive statistics for per-patient maximum prothrombin time laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3

Secondary Endpoints
Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa
Day 1, Day 3
Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time
Day 1, Day 3
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
001EXPERIMENTALRivaroxaban 10mg tablet daily receiving the first dose within two days after admission to the subacute unit. The total duration of combined venous blood clot prevention therapy with enoxaparin and rivaroxaban may not exceed 35 days for patients with total hip replacement or 14 days with total knee replacement
Interventions
NameTypeDescription
RivaroxabanDRUG10mg tablet daily, receiving the first dose within two days after admission to the subacute unit. The total duration of combined venous blood clot prevention therapy with enoxaparin and rivaroxaban may not exceed 35 days for patients with total hip replacement or 14 days with total knee replacement
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Undergone elective total hip or knee replacement surgery * Received postoperative venous blood clot prevention therapy within 24 hours of the surgery * Currently prescribed enoxaparin 30mg subcutaneous (SQ) twice a day or 40mg SQ daily for venous blood clotting prevention with...

Countries:United States
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Competitive Landscape -Arthritis 9 trials