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TAK-783 and methotrexate

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment224

FDA Designations

No designations recorded

Clinical trial landscape

TAK-783 and methotrexate · 1 trial · 1 indication

Phase 2 1
NCT00760968Efficacy and Safety of TAK-783 in Subjects With Rheumatoid ArthritisArthritis, Rheumatoid
COMPLETED224 Analytics
PHASE2COMPLETED
Efficacy and Safety of TAK-783 in Subjects With Rheumatoid Arthritis
Arthritis, Rheumatoid
NCT00760968224
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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 to 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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Frequently asked questions about TAK-783 and methotrexate

What is TAK-783 used for in rheumatoid arthritis?

TAK-783 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It is being evaluated in combination with methotrexate in patients with this condition. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does TAK-783 target?

The molecular target of TAK-783 has not been disclosed in available information. The drug is being studied for its efficacy and safety in rheumatoid arthritis, but its specific mechanism of action has not been publicly detailed.

Who makes TAK-783?

TAK-783 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is conducting clinical trials to evaluate the drug's safety and efficacy in patients with rheumatoid arthritis.

What phase is TAK-783 in?

TAK-783 is in Phase 2 clinical development. A Phase 2 trial has been completed, which evaluated the efficacy and safety of TAK-783 in subjects with rheumatoid arthritis. The drug remains investigational and has not received regulatory approval.

What clinical trials is TAK-783 in?

TAK-783 has one completed Phase 2 clinical trial registered as NCT00760968, titled "Efficacy and Safety of TAK-783 in Subjects With Rheumatoid Arthritis." This randomized, double-blind, active-controlled study enrolled 224 participants across multiple countries including Czechia, Latvia, Romania, Russia, Slovakia, and Ukraine.

Is TAK-783 the same as methotrexate?

No, TAK-783 is not the same as methotrexate. TAK-783 is an investigational drug being studied in combination with methotrexate for rheumatoid arthritis. Methotrexate is an established disease-modifying antirheumatic drug, while TAK-783 is a separate experimental compound.