Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Methotrexate; Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00445770

B1801002

0881A1-315

Details and patient eligibility

About

The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.

Enrollment: 550 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be Japanese and live in Japan
• Must be age 20 to 75 years
• Diagnosed less than or equal to 10 years from time of first visit

Exclusion criteria

• Anyone who has received etanercept or TNF-inhibitors such as infliximab or adalimumab in the past
• Patient with other rheumatic diseases or conditions that could predispose the patient to infection
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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550 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: Etanercept

Drug: Etanercept

2

Experimental group

Treatment:

Drug: Etanercept

Drug: Etanercept

3

Active Comparator group

Treatment:

Drug: Methotrexate