Status:
COMPLETED
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
Lead Sponsor:
Eisai Co., Ltd.
Collaborating Sponsors:
FUJIFILM Toyama Chemical Co., Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-69 years
Phase:
PHASE3
Brief 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 arthrit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2011
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00965757
Start Date
July 31 2009
End Date
September 30 2011
Last Update
December 17 2021
Active Locations (72)
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1
Anjo, Aichi-ken, Japan
2
Ichinomiya, Aichi-ken, Japan
3
Nagoya, Aichi-ken, Japan
4
Okazaki, Aichi-ken, Japan