Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: Amgen
• Treatments: Antirheumatic Agents; Etanercept; Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of Rheumatoid Arthritis (RA)

• Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)

• Active Rheumatoid Arthritis (RA) at time of screening and baseline

Exclusion Criteria:

• Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents

• Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening

• Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening