Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis

Summary

This study is to look at the preliminary efficacy and safety of 2 dose regimens of apremilast (20 mg twice a day and 40 mg once a day) versus placebo in patients with active psoriatic arthritis.

Timeline

Start

2007-03-05

Primary completion

2009-05-09

Completion

2009-05-09

Outcome

Met primary endpoint

registry analysis (superiority test); Apremilast 40 mg QD vs Placebo; p = 0.002; Odds Ratio (OR) 4.190 (95% CI 1.72 to 10.20) NCT00456092 ↗

registry analysis (superiority test); Apremilast 20 mg BID vs Placebo; p < 0.001; Odds Ratio (OR) 5.770 (95% CI 2.40 to 13.88) NCT00456092 ↗

Publications

• Background Schett G, Wollenhaupt J, Papp K, Joos R, Rodrigues JF, Vessey AR, Hu C, Stevens R, de Vlam KL. Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2012 Oct;64(10):3156-67. doi: 10.1002/art.34627.
• Results Strand V, Schett G, Hu C, Stevens RM. Patient-reported Health-related Quality of Life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study. J Rheumatol. 2013 Jul;40(7):1158-65. doi: 10.3899/jrheum.121200. Epub 2013 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apremilast	Small molecule	20 mg	Oral
Subject	Apremilast	Small molecule	40 mg	Oral

Indications