A Partially Blinded, Randomized, Multi-Center, Phase IV Trial to Evaluate Mechanism of Action of Anti-TNF Agents in Rheumatoid Arthritis
RA is characterized by persistent inflammation of peripheral joints, causing pain,
stiffness, swelling, and warmth. Over the past 10 years, advancements in biotechnology have
revolutionized RA therapeutics with biologically-derived immunomodulating compounds.
TNF-alpha inhibitors constitute the largest class of these new biologic therapies. The
purpose of this study is to determine the effectiveness two TNF inhibitors, etanercept and
adalimumab, on memory B lymphocytes (B-cells) in the peripheral blood of participants with
This study will last 24 weeks. Participants will be randomized into one of two arms.
Participants in Arm 1 will receive a subcutaneous injection of etanercept once every week
for 24 weeks. Participants in Arm 2 will receive a subcutaneous injection of adalimumab once
every 2 weeks for 24 weeks.
This study consists of seven study visits after randomization and will occur at study entry
and Weeks 4, 8, 12, 16, 20 and 24. Blood collection will occur at all study visits. A
written participant assessment, vital signs, and physical exam will occur at study entry and
Weeks 12 and 24. Follow-up calls to assess safety are scheduled for Weeks 4, 8, 16, and 20.
Additionally, participants will be offered the opportunity to enter one of four sub-studies
as mentioned in the brief summary above: B Cell Kinetic Sub-Study, Vaccine Response
Sub-Study, Tonsil Biopsy Sub-Study, and Synovial Biopsy Sub-Study. More information on these
sub-studies can be found in the protocol.
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Change in memory B-cells in peripheral blood
Jennifer A. Anolik, MD, PhD
University of Rochester
United States: Federal Government
|University of Alabama||Birmingham, Alabama|
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|
|University of California, San Francisco||San Francisco, California 94143|
|University of Rochester||Rochester, New York 14642|
|University of Chicago||Chicago, Illinois 60637|
|Yale University School Medicine||New Haven, Connecticut 06519|
|Feinstein Institute for Medical Research||Manhassett, New York 11030|