Clinical Trial: A Study to Evaluate the Safety and Efficacy of Apremilast in the Treatment of Skin Disease in Patients With Dermatomyositis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Open Label Study Evaluating the Safety and Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Dermatomyositis

Brief Summary: This study is designed to evaluate the safety and efficacy of an oral medicine (called apremilast) for treating skin involvement in patients with the disease dermatomyositis.

Detailed Summary:
Sponsor: Stanford University

Current Primary Outcome: The Primary Endpoint Analysis Will be Safety, as Measured by the Number of Adverse Events and Serious Adverse Events Occuring During 12 Weeks of Therapy and 4 Weeks of Followup. [ Time Frame: 16 weeks ]

Original Primary Outcome: The primary endpoint analysis for safety will include data on adverse events as well as potential relation of these events to study drug. [ Time Frame: 12 weeks ]

Current Secondary Outcome:

• The Secondary Outcome Measure Will be Efficacy, as Measured by the Number of Participants Experiencing a 30% Decreased in the CDASI-a Score at 12 Weeks. [ Time Frame: Data collected at 12 weeks after baseline visit. ]
  This was an intent to treat analysis--dropouts are considered treatment failures. Missing data at 12 weeks imputed by last observation carried forward.
• The Secondary Outcome Measure Will be Efficacy as Measured by the Mean Change in CDASI-activity at 12 Weeks [ Time Frame: Data collected at baseline at 12 weeks ]
  The CDASI (Cutaneous Dermatomyositis Activity and Severity Index) is a validated instrument to measure skin disease activity in dermatomyositis. A clinically meaningful change is a decrease of 4 points. All missing data are imputed using last observation carried forward. Calculation is performed as the score at 12 weeks minus the score at baseline.

Original Secondary Outcome: The primary efficacy endpoint (which is a secondary endpoint) will include CDASI-a scores at baseline and weeks 4, 8 and 12. [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]

Information By: Stanford University

Dates:
Date Received: April 6, 2010
Date Started: February 2010
Date Completion:
Last Updated: March 3, 2015
Last Verified: March 2015