Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/3/2014 |
Start Date: | September 2011 |
End Date: | January 2014 |
Contact: | Michelle Grimm |
Email: | mgrimm@arthritistreatmentcenter.com |
Phone: | 1-888-71-STUDY |
Open-Label Pre and Post Treatment Arthroscopic Synovial Biopsy Study for the Assessment of Certolizumab Pegol Immunomodulatory Synovial Effects on Select Biomarkers and Gene Expression
The purpose of this study is to conduct an Investigator-Sponsored Study to determine the
potential immunomodulatory effects of Certolizumab Pegol (CZP) treatment at the site of
disease activity (synovial lining) in subjects with rheumatoid arthritis (RA), using pre
treatment and post treatment arthroscopic synovial biopsies and ex vivo on gene expression.
potential immunomodulatory effects of Certolizumab Pegol (CZP) treatment at the site of
disease activity (synovial lining) in subjects with rheumatoid arthritis (RA), using pre
treatment and post treatment arthroscopic synovial biopsies and ex vivo on gene expression.
Inclusion Criteria:
- Signed and dated informed consent document
- Subjects must be at least 18 years of age or older
- Subject must be willing and able to comply with scheduled visits, arthroscopy,
laboratory tests, and other procedures
- Diagnosis of RA based on ACR 1987 Revised Criteria
- Active disease at screening visit
- Methotrexate taken continuously for at least 12 weeks at a stable dosage
- Sexually active women of child-bearing potential and men whose partners are women of
child-bearing potential are required to use adequate contraceptive methods during
participation on this trial
- Treatment with non-steroidal anti-inflammatory drugs (NSAIDS)and oral corticosteroids
(less than or equal to 10 mg/day prednisone or equivalent)is accepted
Exclusion Criteria:
- Diagnosis of any other inflammatory arthritis
- History of infected joint prosthesis that is still in situ
- History of allergy to local anesthetic agents
- Pregnant or lactating women
- Current or recent history of uncontrolled clinically significant
conditions(e.g..,kidney disease, liver disease, class III or IV congestive heart
failure, according to the New York Heart Association)
- History or suspected demyelinating disease of the central nervous system, e.g.
multiple sclerosis or optic neuritis
- Current participation in clinical trial
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