Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Adalimumab; Etanercept; Infliximab; Methotrexate

Criteria

Inclusion Criteria:

1. Met the 1987 ACR Revised Criteria for RA

2. A history of inadequate response to infliximab or adalimumab in combination with methotrexate.

3. A stable dose of oral methotrexate for at least 6 weeks before the baseline visit.

Exclusion Criteria:

1. ACR functional class IV

2. Prior treatment with etanercept; both infliximab and adalimumab; or any immunosuppressive biologic agent other than infliximab or adalimumab.

3. Discontinuation of infliximab or adalimumab for a primary reason other than inadequate efficacy response.