Status:
COMPLETED
Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia
Lead Sponsor:
Michael Schiff, MD
Collaborating Sponsors:
UCB Pharma
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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.
Detailed Description
This is a Phase IV, randomized, multi-center, double-blind, parallel-group 12-week study of Cimzia with concomitant methotrexate (MTX) or other DMARD compared to MTX or other DMARD alone in patients w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01147341
Start Date
July 1 2010
End Date
January 1 2012
Last Update
June 9 2014
Active Locations (12)
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1
Rheumatology Associates of N. Alabama
Huntsville, Alabama, United States, 35801
2
Sun Valley Arthritis Center, Ltd.
Peoria, Arizona, United States, 85381
3
Arizona Arthritis and Rhematolgy Research
Phoenix, Arizona, United States, 85037
4
Sarasota Arthritis Research Center
Sarasota, Florida, United States, 34239