Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)
|ClinicalTrials.gov Identifier: NCT01374971|
Recruitment Status : Completed
First Posted : June 17, 2011
Results First Posted : April 8, 2014
Last Update Posted : April 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Certolizumab Pegol (CZP) Procedure: Arthroscopic synovial tissue biopsy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Study Start Date :||September 2011|
|Primary Completion Date :||July 2012|
|Study Completion Date :||July 2012|
Certolizumab Pegol (CZP)
Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks with arthroscopic synovial tissue biopsy pre- and post-treatment.
Drug: Certolizumab Pegol (CZP)
CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
Other Names:Procedure: Arthroscopic synovial tissue biopsy
Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver.
- Percent Change From Baseline in Synovial TNFa, CXCL13, IL-8, IL-6, IL-1b, IL-10, IP-10, BCL3, CD3E, DUSP4, FOXP3, CD79A, CD138, MMP-3, and MMP-1 After 12 Weeks of Treatment With Certolizumab Pegol (CZP) in Patients With Rheumatoid Arthritis [ Time Frame: Baseline and Week 12 ]Synovial tissue biopsy samples were taken at baseline and at 12 weeks after starting treatment with CZP. These samples were analyzed to determine the concentrations of select biomarkers and to determine the percent change in concentration from baseline to week 12.
- Percent Change From Screening in Disease Activity Score (DAS) 28 ESR After 14 Weeks of Treatment [ Time Frame: Screening and Week 14 ]The DAS 28 ESR is a score calculated from the results of a 28-count joint assessment (total number of tender joint possible is 28, and total number of swollen joints possible is 28), the Erythrocyte Sedimentation Rate (ESR), and the Patient Global Assessment (measured using a 100 mm visual analogue scale, with the lowest possible score of 0 mm meaning the subject is not affected at all by arthritis and the highest possible score of 100 mm meaning the subject is severely affected by arthritis). A lower DAS 28 ESR indicates less active disease, and a higher DAS 28 ESR indicates more active disease. The DAS 28 ESR was calculated for each subject at the screening visit and at the Week 14 final visit. The percent change was then calculated for each patient, and a mean percent change for all subjects was determined.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374971
|United States, Maryland|
|Arthritis Treatment Center|
|Frederick, Maryland, United States, 21702|
|Principal Investigator:||Nathan Wei, MD,FACP,FACR||Nathan Wei, MD, PA d/b/a Arthritis Treatment Center, 301-694-5800|