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TAK-715 and methotrexate

Phase 2

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |Takeda Pharmaceutical Company Limited|Last Updated: Jun 11, 2010

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment432
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00760864Safety and Efficacy of TAK-715 in Subjects With Rheumatoid ArthritisPHASE2 COMPLETED 432 — — Aug 1, 2004Sep 1, 2005Jun 11, 2010 - —
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Study Endpoints
Primary Endpoints
Composite ACR 20% improvement response rate from baseline with 3 of the following: pain assessment; disease activity; physical function; C-reactive protein and erythrocyte sedimentation rate.
Week 6
Secondary Endpoints
Composite ACR 50% improvement response rate from baseline with 3 of the following: swollen-tender joint counts; pain assessment; disease activity; physical function; C-reactive protein and erythrocyte sedimentation rate.
Week 6.
Composite ACR 70% improvement response rate from baseline with 3 of the following: swollen-tender joint counts; pain assessment; disease activity; physical function; C-reactive protein and erythrocyte sedimentation rate.
Week 6.
Change from baseline in swollen and tender joint counts.
Week 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TAK-715 25 mg BIDEXPERIMENTAL -
TAK-715 50 mg BIDEXPERIMENTAL -
TAK-715 100 mg BIDEXPERIMENTAL -
MethotrexateACTIVE_COMPARATOR -
Interventions
NameTypeDescription
TAK-715 and methotrexateDRUGTAK-715 25 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.
MethotrexateDRUGTAK-715 placebo-matching, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Had a diagnosis of rheumatoid arthritis using American College of Rheumatology criteria of at least 6 months duration. * A female subject of childbearing potential who is sexually active must agree to use adequate contraception, and must be neither pregnant nor lactating from ...

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