NCT00393471

Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.

A Double-blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 615 (planned)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.

Detailed description

Etanercept is an injection administered under the skin twice weekly. Methotrexate is a tablet to be taken once weekly. Patients will not know which treatment they are on. Patients will need to meet the study criteria to be enrolled in the study and sign an informed consent.

Conditions

• Active Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Etanercept

Timeline

• Start date: 2000-10-01
• Completion: 2001-10-01
• First posted: 2006-10-27
• Last updated: 2023-12-13

Locations

88 sites across 19 countries: Australia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, United Kingdom