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

Nathan Wei, MD, FACP, FACR:

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Certolizumab Pegol (CZP); Procedure: Arthroscopic synovial tissue biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01374971

ATC2011

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Certolizumab Pegol (CZP)

Other group

Description:

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.

Treatment:

Drug: Certolizumab Pegol (CZP)

Procedure: Arthroscopic synovial tissue biopsy