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

Wyeth

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00484237

0881A1-3324

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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