Clinical Trial: A Randomized Multicenter Study for Isolated Skin Vasculitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Multicenter Study for Isolated Skin Vasculitis

Brief Summary: Multi-center sequential multiple assignment randomized trial comparing the effectiveness of three different standard of care treatment options for patients with isolated skin vasculitis.

Detailed Summary:

Eligible patients will be initially randomized (1:1:1) to receive one of the 3 medications under investigation (colchicine 0.6 mg x 2/day; dapsone 150 mg/day; azathioprine 2 mg/kg/day) for 6 months. Endpoint is response to treatment at month 6 (stage 1).

If the patient has to discontinue the study drug within the 6 month study period or during the subsequent follow-up period (up to month 12) because of a lack of response (or failure), flare or side effect, he/she will be randomized again to receive one of the remaining two study drugs (stage 2, with a 1:1 randomization ratio) for 6 months. Endpoint in this second stage will again be the response to treatment at 6 months.


Sponsor: University of Pennsylvania

Current Primary Outcome: Efficacy of the study drugs for the treatment of skin vasculitis. [ Time Frame: Response to therapy at month 6 of the pooled study stages 1 and 2. ]

Compare response to therapies.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response rates for each of the study drugs [ Time Frame: Response evaluated months 3, 6 and 12 ]
    Proportion of patient with complete response and significant response to therapy at months 3, 6 and 12
  • Physician and patient's global assessment of response [ Time Frame: Assessed at months 0, 1, 3, 6, 9, and 12. ]
  • Skindex29 score [ Time Frame: Assessed at months 1, 3, 6, 9, and 12. ]
  • Health-related quality of life [ Time Frame: Assessed at months 1, 3, 6, 9, and 12. ]
    Health-related quality of life as measured using SF-36 and Patient-Reported Outcomes Measurement Information System (PROMIS)


Original Secondary Outcome:

  • Response rates for each of the study drugs [ Time Frame: Respone evaluated months 3, 6 and 12 ]
    Proportion of patient with complete response and significant response to therapy at months 3, 6 and 12
  • Physician and patient's global assessment of response [ Time Frame: Assessed at months 0, 1, 3, 6, 9, and 12. ]
  • Skindex29 score [ Time Frame: Assessed at months 1, 3, 6, 9, and 12. ]
  • Health-related quality of life [ Time Frame: Assessed at months 1, 3, 6, 9, and 12. ]
    Health-related quality of life as measured using SF-36 and PROMIS


Information By: University of Pennsylvania

Dates:
Date Received: October 18, 2016
Date Started: January 2017
Date Completion: December 2019
Last Updated: January 3, 2017
Last Verified: January 2017