Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)

This study has been completed.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Nathan Wei, MD, FACP, FACR:, Arthritis Treatment Center, Maryland
ClinicalTrials.gov Identifier:
NCT01374971
First received: June 14, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Certolizumab Pegol (CZP)
Procedure: Arthroscopic synovial tissue biopsy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Arthritis Treatment Center, Maryland:

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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Screening and Week 14 ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Brand Name: Cimzia
  • UCB product: Certolizumab Pegol (CDP870)
  • Pre-filled syringe: NDC50474-710-79
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374971

Locations
United States, Maryland
Arthritis Treatment Center
Frederick, Maryland, United States, 21702
Sponsors and Collaborators
Nathan Wei, MD, FACP, FACR:
University of California, San Diego
Investigators
Principal Investigator: Nathan Wei, MD,FACP,FACR Nathan Wei, MD, PA d/b/a Arthritis Treatment Center, 301-694-5800
  More Information

No publications provided

Responsible Party: Nathan Wei, MD, FACP, FACR:, Nathan Wei, MD, FACP, FACR, Arthritis Treatment Center, Maryland
ClinicalTrials.gov Identifier: NCT01374971     History of Changes
Other Study ID Numbers: ATC2011
Study First Received: June 14, 2011
Results First Received: January 10, 2014
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Arthritis Treatment Center, Maryland:
Rheumatoid Arthritis
Cimzia
Certolizumab Pegol
Arthroscopic Synovial biopsy
Office Based Procedure
Biologic
Tumor Necrosis Factor (TNF)
Anti-TNF

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014