Study of Adalimumab to Lower Cardiovascular Risk in RA Patients With Well Controlled Joint Disease
Status:
Completed
Trial end date:
2017-07-01
Target enrollment:
Participant gender:
Summary
Rheumatoid arthritis patients are at increased risk of cardiovascular disease because of
systemic inflammation that can persist even in patients with well-controlled joint disease.
We hypothesize that adding an anti-tumor necrosis factor medication, adalimumab, to standard
non-biologic therapy for rheumatoid arthritis will improve endothelial function (reduce
cardiovascular risk) in these patients. The design of the trial is as follows: 18 month
prospective, randomized, double-blind crossover trial comparing the addition of adalimumab to
the addition of placebo. The primary endpoint is a change in endothelial cell function, as
detected by brachial artery FMD, at 6 months of adalimumab treatment compared to 6 months of
placebo.
Phase:
Phase 4
Details
Lead Sponsor:
Jonathan Graf University of California, San Francisco
Collaborators:
AbbVie American College of Rheumatology Research and Education Foundation