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

This study is currently recruiting participants.
Verified September 2011 by Arthritis Treatment Center, Maryland
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: September 30, 2011
Last verified: September 2011
History of Changes
  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: Open Label 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • The immunomodulatory effects of Certolizumab Pegol (CZP) on select biomarkers and gene expression in patients with Rheumatoid Arthritis [ Time Frame: 14-Week study period ] [ Designated as safety issue: No ]
    To evaluate the synovial effects, either direct or indirect, of the role of CZP on the synovium, a reduction in markers of inflammation should be detectable. The presence and distribution of CZP in the synovium is an important PK variable and may be of use in future co-localization experiments. Rheumatoid factor positive patients have been selected because the RF production can be measured in synovial explants.


Secondary Outcome Measures:
  • Assessing clinical response rates and established safety parameters [ Time Frame: 14-Week study period ] [ Designated as safety issue: No ]
    Assess the clinical response rate as measured by the American College of Rheumatology (ACR) 20%,50% and 70%. The reduction of disease activity by DAS28(CRP)Disease Activity Score-28 C-reactive protein. The improvement in individual components of the ACR criteria, for example, tender joint count, swollen joint count, Health Assessment Questionnaire-Disability Index, Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, and Physician's Global Assessment of Disease Activity.


Estimated Enrollment: 10
Study Start Date: September 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Open Label 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.
    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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374971

Contacts
Contact: Michelle Grimm 1-888-71-STUDY mgrimm@arthritistreatmentcenter.com
Contact: Sheila Delauter, RN 301-624-1165 sdelauter@arthritistreatmentcenter.com

Locations
United States, Maryland
Arthritis Treatment Center Recruiting
Frederick, Maryland, United States, 21702
Contact: Michelle Grimm     301-624-1164 ext 232     mgrimm@arthritistreatamentcenter.com    
Contact: Sheila K. Delauter, RN,CCRC     301-624-1165 ext 228     sdelauter@arthritistreatmentcenter.com    
Principal Investigator: Nathan Wei, MD,FACP,FACR            
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
Last Updated: September 30, 2011
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
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 May 22, 2013