Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)
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
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 rheumatoid-arthritis
Started Sep 2011
Shorter than P25 for phase_3 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2011
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
April 8, 2014
CompletedApril 8, 2014
February 1, 2014
10 months
June 14, 2011
January 10, 2014
February 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
Baseline and Week 12
Secondary Outcomes (1)
Percent Change From Screening in Disease Activity Score (DAS) 28 ESR After 14 Weeks of Treatment
Screening and Week 14
Study Arms (1)
Certolizumab Pegol (CZP)
OTHERCertolizumab 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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 American College of Rheumatology (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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nathan Wei, MD, FACP, FACR:lead
- University of California, San Diegocollaborator
Study Sites (1)
Arthritis Treatment Center
Frederick, Maryland, 21702, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size
Results Point of Contact
- Title
- Nathan Wei, MD
- Organization
- Nathan Wei, MD, PA dba Arthritis Treatment Center
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Wei, MD,FACP,FACR
Nathan Wei, MD, PA d/b/a Arthritis Treatment Center, 301-694-5800
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Nathan Wei, MD, FACP, FACR
Study Record Dates
First Submitted
June 14, 2011
First Posted
June 17, 2011
Study Start
September 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
April 8, 2014
Results First Posted
April 8, 2014
Record last verified: 2014-02