A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis

Wyeth is now a wholly owned subsidiary of Pfizer80 enrolled

Overview

This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

etanerceptDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Presence of \>6 swollen joints and \>6 tender joints * Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD) * Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit Exclusion Criteria: * Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors * Received investigational drugs within 6 months of the baseline visit * Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit

Locations (13)

Unnamed facility

Goshogawara, Aomori, Japan

Unnamed facility

Choseigun, Chiba, Japan

Unnamed facility

Yotsukaidō, Chiba, Japan

Unnamed facility

Fukuoka, Fukuoka, Japan

Outcomes

Primary Outcomes

The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12).

Secondary Outcomes

ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness.

Data from ClinicalTrials.gov

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