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

PHASE3CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Rheumatoid Arthritis
Interventions
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 weeks.

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.

Trial Locations (1)

21702

Arthritis Treatment Center, Frederick

All Listed Sponsors
collaborator

University of California, San Diego

OTHER

lead

Nathan Wei, MD, FACP, FACR:

OTHER

NCT01374971 - Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia) | Biotech Hunter | Biotech Hunter