Rheumatoid Arthritis Clinical Trial
Official title:
The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment
The purpose of this study is to compare the effects of apremilast with a placebo (an inactive
substance that looks like apremilast) on you and other people with rheumatoid arthritis.
The investigators will be collecting information in this study to help us determine -
- the safety of apremilast in patients with active rheumatoid arthritis
- how long it takes for patients with active rheumatoid arthritis to respond to apremilast
- how long the effects of apremilast last after the treatment has ended.
Many manifestations associated with RA result from, or are significantly influenced by, the
effects of pro-inflammatory cytokines (e.g., TNF, IL-1, IL-6). Specific inhibition of these
cytokines with newer, parenterally administered biologic agents has revolutionized the
treatment of RA. Apremilast is a novel, orally administered drug which approaches the
reduction of pro-inflammatory cytokines via inhibition of phosphodiesterase type 4 (PDE4).
Apremilast, Acetamide, N-[2-[ (1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)
ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl] is a phosphodiesterase type 4 (PDE4) inhibitor
under development for use in the treatment of inflammatory conditions.
PDE4 is one of the major phosphodiesterases expressed in leukocytes. Inhibitors of PDE4 cause
accumulation of intracellular cyclic adenosine monophosphate (cAMP), which in turn activates
protein kinase A and other downstream effectors, resulting in inhibition of pro-inflammatory
cytokine transcription and other cellular responses such as neutrophil degranulation,
chemotaxis, and adhesion to endothelial cells.
In human cellular models, apremilast inhibited production of inflammatory mediators such as
TNF-α, IL-12, IL-2, IFN-γ, IL-5, IL-8, leukotriene B4 (LTB4), and the adhesion molecule
CD18/CD11b (Mac-1).
Apremilast has also been shown to be a potent anti-inflammatory agent in several animal
models of inflammation.
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