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

NCT01374971 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-04-08

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01374971 on ClinicalTrials.gov