To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound.
Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. Only Adverse Event (AE) data will be summarized in a table, with frequency counts and percentages.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
10
Los Angeles, California, United States
4
Walnut Creek, California, United States
8
Wheaton, Maryland, United States
1
Voorhees Township, New Jersey, United States
6
Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12
Time frame: From Baseline (Week 0) to Week 12
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Rochester, New York, United States
7
Franklin, Wisconsin, United States