drugset / Trial / NCT01893996
Study of Adalimumab to Lower Cardiovascular Risk in RA Patients With Well Controlled Joint Disease
Phase 4
Completed
63 enrolled
Jonathan Graf
AbbVie · collabAmerican College of Rheumatology Research and Education Foundation · collab
RandomizedCrossoverQuadruple-blindPrevention
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.
Timeline
- Start
- 2013-07
- Primary completion
- 2017-07
- Completion
- 2017-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adalimumab | Monoclonal antibody | — | — |