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

Last updated: February 26, 2014
Sponsor: Nathan Wei, MD, FACP, FACR:
Overall Status: Completed

Phase

3

Condition

Joint Injuries

Dermatomyositis (Connective Tissue Disease)

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT01374971
ATC2011
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofchild-bearing potential are required to use adequate contraceptive methods duringparticipation 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

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 significantconditions(e.g..,kidney disease, liver disease, class III or IV congestive heartfailure, 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

Study Design

Total Participants: 12
Study Start date:
September 01, 2011
Estimated Completion Date:
July 31, 2012

Connect with a study center

  • Arthritis Treatment Center

    Frederick, Maryland 21702
    United States

    Site Not Available

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