A Randomized, Double-Blind, Multicenter, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Active Rheumatoid Arthritis

Pfizer1 site in 1 country550 target enrollmentJuly 2006

ConditionsArthritis, Rheumatoid

InterventionsEtanercept Methotrexate

DrugsEtanercept Methotrexate

Overview

Phase: Phase 3
Intervention: Etanercept
Conditions: Arthritis, Rheumatoid
Sponsor: Pfizer
Enrollment: 550
Locations: 1
Primary Endpoint: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

July 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

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

Arms & Interventions

1

Intervention: Etanercept

2

Intervention: Etanercept

3

Intervention: Methotrexate

Outcomes

Primary Outcomes

Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52

Time Frame: Week 52

mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.

Secondary Outcomes

Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52(Baseline, Week 24, and Week 52)
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Percentage of Participants With no Progression of Joint Destruction at Week 52(Baseline and Week 52)
Percentage of Participants With an ACR70 Response(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24(Week 24)
Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in Erosion Score at Weeks 24 and 52(Baseline, Week 24, and Week 52)
Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Percentage of Participants With an ACR50 Response(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)