Clinical trial NCT01374971: Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)
Official title: Open-Label Pre and Post Treatment Arthroscopic Synovial Biopsy Study for the Assessment of Certolizumab Pegol Immunomodulatory Synovial Effects on Select Biomarkers and Gene Expression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Cimzia
Certolizumab Pegol
Arthroscopic Synovial biopsy
Office Based Procedure
Biologic
Tumor Necrosis Factor (TNF)
Anti-TNF
Lead sponsor: Arthritis Treatment Center, Maryland
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2011-06-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Percent Change From Baseline in Synovial TNFa, CXCL13, IL-8, IL-6, IL-1b, IL-10, IP-10, BCL3, CD3E, DUSP4, FOXP3, CD79A, CD138, MMP-3, and MMP-1 After 12 Weeks of Treatment With Certolizumab Pegol (CZP) in Patients With Rheumatoid Arthritis
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percent Change From Screening in Disease Activity Score (DAS) 28 ESR After 14 Weeks of Treatment
timeFrame: Screening and Week 14
Other outcomes:
Locations:
city: Frederick
country: United States
facility: Arthritis Treatment Center
state: Maryland
Study officials:
affiliation: Nathan Wei, MD, PA d/b/a Arthritis Treatment Center, 301-694-5800
name: Nathan Wei, MD,FACP,FACR
role: PRINCIPAL_INVESTIGATOR
References: