NCT01250548

The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment (CARAT)

The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	apremilast	30 mg BID apremilast taken orally for the first 12 weeks followed by responders randomized to either 30 mg BID apremilast (oral) or 30 mg BID placebo (oral) for 8 weeks
OTHER	Placebo

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2010-12-01
• Last updated: 2014-09-03

Locations

1 site across 1 country: United States