Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, anti-TNF therapy
Eligibility 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
Sites / Locations
- Rheumatology Associates of N. Alabama
- Sun Valley Arthritis Center, Ltd.
- Arizona Arthritis and Rhematolgy Research
- Sarasota Arthritis Research Center
- Physician Research Collaboration, LLC
- Westroads Medical Group
- Morristown Memorial Hospital
- Buffalo Rheumatology
- Rheumatology Associates of Long Island
- Altoona Center for Clinical Research
- Mountain State Clinical Research
- Rheumatology and Immunotherapy Center
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
placebo
active treatment with Cimzia
Placebo (0.9% sodium chloride) given as 2 subcutaneous (sc) injections at weeks 0, 2, and 4, followed y 1 sc injection given an weeks 6, 8, and 10. At week 12 subjects entered the open label phase. Subjects received 400 mg of Cimzia (CZP) given as two 200 mg subcutaneous (sc) injections at weeks 12,14 and 16, followed by 1 sc injection at weeks 18, 20, and 22.
400 mg of Cimzia (CZP) given as two 200 mg subcutaneous (sc) injections at weeks 0, 2, and 4, followed by 1 sc injection at weeks 6, 8, and 10. At week 12 subjects entered the open label phase. Subjects received 400 mg of Cimzia (CZP) given as two 200 mg subcutaneous (sc) injections at weeks 12,14 and 16, followed by 1 sc injection at weeks 18, 20, and 22.