Switching Anti-TNF-alpha Agents in Patients With RA With An Inadequate Response to TNF-alpha Inhibition
Over the past 10 years, advancements in biotechnology have revolutionized Rheumatoid
Arthritis (RA) therapeutics with biologically-derived immunomodulating compounds. Tumor
Necrosis Factor (TNF) alpha inhibitors constitute the largest class of these new biologic
therapies. The purpose of this study is to determine the effectiveness of switching to an
alternative TNF-alpha inhibitor in comparison to continuing treatment with an existing
TNF-alpha inhibitor in adults suffering from RA who have had inadequate clinical response to
the study drugs etanercept and adalimumab.
This study will last approximately 16 weeks. Participants will be randomized into two arms
and receive injections once per week for 12 weeks. Participants in the adalimumab arm will
receive alternating subcutaneous adalimumab and adalimumab placebo injections. Participants
in the etanercept arm will receive subcutaneous etanercept injections.
This study consists of thirteen study visits after randomization. Study visits will occur on
a weekly basis for 12 weeks prior to a follow-up visit at Week 16. A vital signs measurement
and adverse event assessment will occur at each visit. A physical exam, assessment of tender
and swollen joints, medication assessment, and blood collection will occur at Weeks 4, 8,
12, and 16.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers.
The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).
Baseline, Week 12
Larry Moreland, MD
University of Pittsburgh
United States: Federal Government
|University of Alabama||Birmingham, Alabama|
|Stanford University||Stanford, California 94305|
|Oklahoma Medical Research Foundation||Oklahoma City, Oklahoma 73104|
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|University of Utah||Salt Lake City, Utah|
|Duke University Medical Center||Durham, North Carolina 27710|
|University of Rochester||Rochester, New York 14642|
|University of Chicago Medical Center||Chicago, Illinois 60637|
|Baylor Research Institute||Dallas, Texas 75246|
|Altoona Center for Clinical Research||Duncansville, Pennsylvania 16635|
|Yale New Haven Hospital||New Haven, Connecticut 06520|
|Sarasota Arthritis Research Center||Sarasota, Florida 34239|
|Tampa Medical Group||Tampa, Florida 33614|
|Justus Fiechtner, MD, PC||Lansing, Michigan 48910|
|Feinstein Institute for Medical Research NS-LIJ||Manhassett, New York 14642|
|Carolina Bone and Joint||Charlotte, North Carolina 28210|