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TAK-783 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 Enrollment224
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00760968Efficacy and Safety of TAK-783 in Subjects With Rheumatoid ArthritisPHASE2 COMPLETED 224 — — Aug 1, 2007Feb 1, 2009Jun 11, 201025 Czechia, Latvia +4
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Study Endpoints
Primary Endpoints
Percent of subjects with greater than or equal to 20% improvement in Arthritis Signs and Symptoms according to the American College of Rheumatology
Weeks 2, 4, 8, and 12 or Final Visit.
Change from Baseline in Treatment-emergent adverse events.
Weeks 2, 4, 8, and 12 or Final Visit.
Change from Baseline in Vital signs.
Weeks 2, 4, 8, and 12 or Final Visit.
Change from Baseline in Electrocardiogram findings.
Weeks 2, 4, 8, and 12 or Final Visit.
Change from Baseline in Spirometry tests.
Weeks 2, 4, 8, and 12 or Final Visit.
Change from Baseline in Hematology Laboratory tests.
Weeks 2, 4, 8, and 12 or Final Visit.
Change from Baseline in Chemistry Laboratory tests.
Weeks 2, 4, 8, and 12 or Final Visit.
Change from Baseline in Urinalysis Laboratory tests.
Weeks 2, 4, 8, and 12 or Final Visit.
Secondary Endpoints
Percent of subjects with greater than or equal to 50% improvement in Arthritis Signs and Symptoms according to the American College of Rheumatology
Weeks 2, 4, 8, and 12 or Final Visit.
Percent of subjects with greater than or equal to 70% improvement in Arthritis Signs and Symptoms according to the American College of Rheumatology
Weeks 2, 4, 8, and 12 or Final Visit.
Change from Baseline in individual Arthritis Signs and Symptoms according to the American College of Rheumatology.
Weeks 2, 4, 8, and 12 or Final Visit.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TAK-783 100 mg QD + MethotrexateEXPERIMENTAL -
MethotrexateACTIVE_COMPARATOR -
Interventions
NameTypeDescription
TAK-783 and methotrexateDRUGTAK-783 100 mg, tablets, orally, once daily and methotrexate stable dose therapy for up to 12 weeks.
MethotrexateDRUGTAK-783 placebo-matching tablets, orally, once daily and methotrexate stable dose therapy for up to 12 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Had a diagnosis of rheumatoid arthritis using American College of Rheumatology criteria of at least 6 months duration and less than or equal to 3 years. * A female subject of childbearing potential who is sexually active must agree to use adequate contraception, and must be ne...

Countries:CzechiaLatviaRomaniaRussiaSlovakiaUkraine
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