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

Eisai

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: T-614

Study type: Interventional

Funder types: Industry

Identifiers

NCT00965757

T614-ADN

Details and patient eligibility

About

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

Enrollment: 253 patients

Sex: All

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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253 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: T-614

2

Placebo Comparator group

Treatment:

Drug: Placebo