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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01374971
Recruitment Status : Completed
First Posted : June 17, 2011
Results First Posted : April 8, 2014
Last Update Posted : April 8, 2014
University of California, San Diego
Information provided by (Responsible Party):
Nathan Wei, MD, FACP, FACR:, Arthritis Treatment Center, Maryland

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.

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
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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 [ 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01374971

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

Responsible Party: Nathan Wei, MD, FACP, FACR:, Nathan Wei, MD, FACP, FACR, Arthritis Treatment Center, Maryland Identifier: NCT01374971     History of Changes
Other Study ID Numbers: ATC2011
First Posted: June 17, 2011    Key Record Dates
Results First Posted: April 8, 2014
Last Update Posted: April 8, 2014
Last Verified: February 2014

Keywords provided by Nathan Wei, MD, FACP, FACR:, Arthritis Treatment Center, Maryland:
Rheumatoid Arthritis
Certolizumab Pegol
Arthroscopic Synovial biopsy
Office Based Procedure
Tumor Necrosis Factor (TNF)

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents