A Randomized Multicenter Study for Isolated Skin Vasculitis (ARAMIS)

CURRENTLY ENROLLING: YES

 

The purpose of this study is to evaluate different treatment options for patients with skin vasculitis (also called cutaneous vasculitis).

YES. The medications you need to take to participate in the study is either colchicine, dapsone, or azathioprine. You will not be taking all 3 at any point in this study. You will be randomized to take only 1 of the 3.

Vasculitis frequently affects the skin and causes different kinds of rashes (lesions). Because no research studies have provided answers to the question of what therapy for skin vasculitis is best, treatment decisions for patients with skin vasculitis are made based upon the treating doctor’s experience and expert opinions. The doctors involved in this study are hopeful that the information gathered from this study will help doctors and patients understand what the best treatment options are for patients with skin vasculitis.

This study will compare the effectiveness of the three different drugs for the treatment of skin vasculitis, look at how patients respond to the study drugs, and see if there are characteristics that predict which patients will respond to which drugs.

  1. Patients must first have a diagnosis of the following types of isolated skin vasculitis:
    • Isolated cutaneous small-vessel (SVV)
    • Isolated cutaneous medium-vessel vasculitis (MVV)
    • Cutaneous polyarteritis nodosa (cPAN)
    • IgA vasculitis (Henoch-Schönlein purpura, IgAV)

  2. Have a confirmed diagnosis of vasculitis by skin biopsy before enrolling in this study (earlier, at diagnosis, and/or just prior to enrollment) that confirms the diagnosis of vasculitis
  3. Have active skin vasculitis lasting for at least 1 month continuously and/or have had 2 or more flares over the six months before enrolling
  4. Have active/ongoing skin vasculitis lesions at the time of enrollment (old scars alone will not be considered active vasculitis

12-18 months

The study consist of 2 stages. In stage 1, eligible patients will initially be randomized to receive one of the 3 medications under investigation for 6 months. For stage 2, participants may remain on the same drug for another 6 months if the drug is helping and symptoms have improved. If the stage 1 drug does not help with relieving symptoms, participants may be randomized to one of the remaining 2 drugs and will take the new medication for up to 12 months.

Thank you for your interest! If you wish to learn more and sign up for the study, please contact:

JOSHUA BRYER
jbryer@pennmedicine.upenn.edu
215-662-6597