A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis

NCT00760864 Phase 2 COMPLETED

The purpose of this study is to evaluate the safety and efficacy of TAK-715, twice daily (BID), in the treatment of rheumatoid arthritis signs and symptoms in patients with a partial response to methotrexate.

Details

Lead sponsor	Takeda
Phase	Phase 2
Status	COMPLETED
Enrolment	432
Start date	2004-08
Completion	2005-09

Conditions

• Arthritis, Rheumatoid

Interventions

• TAK-715 and methotrexate
• TAK-715 and methotrexate
• TAK-715 and methotrexate
• Methotrexate

Primary outcomes

• 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