Overview

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

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Etanercept
Criteria
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