Back to resultsRheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Certolizumab Pegol (CZP)
Arthroscopic synovial tissue biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Cimzia, Certolizumab Pegol, Arthroscopic Synovial biopsy, Office Based Procedure, Biologic, Tumor Necrosis Factor (TNF), Anti-TNF
Eligibility Criteria
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 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
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
Sites / Locations
- Arthritis Treatment Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Certolizumab Pegol (CZP)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percent Change From Screening in Disease Activity Score (DAS) 28 ESR After 14 Weeks of Treatment
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.
Full Information
NCT ID
NCT01374971
First Posted
June 14, 2011
Last Updated
February 26, 2014
Sponsor
Nathan Wei, MD, FACP, FACR:
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01374971
Brief Title
Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nathan Wei, MD, FACP, FACR:
Collaborators
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Cimzia, Certolizumab Pegol, Arthroscopic Synovial biopsy, Office Based Procedure, Biologic, Tumor Necrosis Factor (TNF), Anti-TNF
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Certolizumab Pegol (CZP)
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Certolizumab Pegol (CZP)
Other Intervention Name(s)
Brand Name: Cimzia, UCB product: Certolizumab Pegol (CDP870), Pre-filled syringe: NDC50474-710-79
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic synovial tissue biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Screening in Disease Activity Score (DAS) 28 ESR After 14 Weeks of Treatment
Description
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.
Time Frame
Screening and Week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Wei, MD,FACP,FACR
Organizational Affiliation
Nathan Wei, MD, PA d/b/a Arthritis Treatment Center, 301-694-5800
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthritis Treatment Center
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)
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