A Randomized Multicenter Study for Isolated Skin Vasculitis — ARAMIS  

IgA Vasculitis Clinical Trial

Official title: A Randomized Multicenter Study for Isolated Skin Vasculitis

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Cutaneous Polyarteritis Nodosa
• Henoch-Schönlein Purpura
• IgA Vasculitis
• Polyarteritis Nodosa
• Primary Cutaneous Vasculitis
• Purpura
• Vasculitis

• NCT number: NCT02939573
• Study type: Interventional
• Source: University of Pennsylvania
• Contact: Carol McAlear, MA
• Email: cmcalear@upenn.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2017
• Completion date: December 31, 2025