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

NCT ID: NCT01374971

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-07-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Certolizumab Pegol (CZP)

Intervention Type: DRUG

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.

Arthroscopic synovial tissue biopsy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Other Intervention Names

Brand Name: Cimzia; UCB product: Certolizumab Pegol (CDP870); Pre-filled syringe: NDC50474-710-79

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

Nathan Wei, MD, FACP, FACR:

OTHER

Sponsor Role: lead

Responsible Party

Nathan Wei, MD, FACP, FACR:

Nathan Wei, MD, FACP, FACR

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nathan Wei, MD,FACP,FACR

Role: PRINCIPAL_INVESTIGATOR

Nathan Wei, MD, PA d/b/a Arthritis Treatment Center, 301-694-5800

Locations

Arthritis Treatment Center

Frederick, Maryland, United States

Countries

United States

Other Identifiers

ATC2011

Identifier Type: -

Identifier Source: org_study_id