Recent Updates
Recently added Catalysts

TAK-715 and methotrexate

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment432

FDA Designations

No designations recorded

Clinical trial landscape

TAK-715 and methotrexate · 1 trial · 1 indication

Phase 2 1
NCT00760864Safety and Efficacy of TAK-715 in Subjects With Rheumatoid ArthritisArthritis, Rheumatoid
COMPLETED432 Analytics
PHASE2COMPLETED
Safety and Efficacy of TAK-715 in Subjects With Rheumatoid Arthritis
Arthritis, Rheumatoid
NCT00760864432
Unlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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 ...

Unlock Eligibility Criteria

Frequently asked questions about TAK-715 and methotrexate

What is TAK-715 used for in rheumatoid arthritis?

TAK-715 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It is evaluated in combination with methotrexate in patients with this condition. The drug is currently in Phase 2 clinical development and is not approved for any use.

Who is developing TAK-715?

TAK-715 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the safety and efficacy of TAK-715 in patients with rheumatoid arthritis.

What phase is TAK-715 in?

TAK-715 is in Phase 2 clinical development. A Phase 2 trial has been completed to assess its safety and efficacy in subjects with rheumatoid arthritis. The drug remains investigational and has not received regulatory approval.

What clinical trials is TAK-715 in?

TAK-715 has been studied in one completed Phase 2 clinical trial, identified as NCT00760864. This randomized, double-blind, active-controlled study enrolled 432 participants with rheumatoid arthritis and evaluated the safety and efficacy of TAK-715 in combination with methotrexate.

Is TAK-715 the same as methotrexate?

No, TAK-715 is not the same as methotrexate. TAK-715 is an investigational small molecule being developed by Takeda, while methotrexate is an established disease-modifying antirheumatic drug. In clinical trials, TAK-715 is studied in combination with methotrexate for rheumatoid arthritis.