Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab Pegol (CZP); Arthroscopic synovial tissue biopsy
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.; 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.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Cimzia; Certolizumab Pegol; Arthroscopic Synovial biopsy; Office Based Procedure; Biologic; Tumor Necrosis Factor (TNF); Anti-TNF

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 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