A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.
• Collaborators: FUJIFILM Toyama Chemical Co., Ltd.; Toyama Chemical Co., Ltd.
• Treatments: Methotrexate

Criteria

Inclusion criteria:

• Subjects who have a diagnosis of Rheumatoid Arthritis by the ACR criteria

• Age greater or 20 years and less than 70 years old

Exclusion criteria:

• Subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study

• Women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant