Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of the study is to determine if Cimzia is safe and effective in subjects who have received previous treatment with a TNF-alpha inhibitor other than Cimzia.

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

Details

• Lead Sponsor: Michael Schiff, MD
• Collaborator: UCB Pharma
• Treatments: Certolizumab Pegol

Criteria

Inclusion Criteria:

• Have a diagnosis of RA at least 6 months

• Have received treatment with a TNF-alpha inhibitor

• Be receiving Methotrexate (with folic acid)at a dose of at least 10mg/week or another non-biologic DMARD if Methotrexate intolerant *Have at least 6 tender joint and 6 swollen joints*

• Have an CRP greater than or equal to ULN

• Availability of a chest x-ray that shows no evidence of active TB or infection

Exclusion Criteria:

• Prior exposure to Cimzia

• Prior treatment with B-cell depleting therapy

• No significant response to previous TNF inhibitor

• Congestive heart failure

• Clinically abnormal laboratory tests

• History of cancer

• Active TB