A Randomized Multicenter Study for Isolated Skin Vasculitis
University of Pennsylvania
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.
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. En…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with primary skin vasculitis, not associated with any significant extra-cutaneous involvement that would require specific immunosuppressive therapy. Eligible patients will have a diagnosis of either: * Isolated cutaneous small vessel (SV) or medium-sized vessel (MV) vasculitis or cutaneous polyarteritis nodosa (PAN) * IgA vasculitis (IgA, formerly Henoch-Schönlein purpura), without active and/or progressing renal involvement (stable glomerular filtration rate (GFR) \>60 ml/min; absence of, or mild-and-stable microscopic hematuria without red blood cell c…
Interventions
- DrugColchicine
Randomized to colchicine 0.6 mg x 2/day
- DrugDapsone
Randomized to dapsone 150 mg/day
- DrugAzathioprine
Randomized to azathioprine 2 mg/kg/day
Locations (16)
- University of Kansas Medical CenterKansas City, Kansas
- Boston University School of MedicineBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- Northwell HealthLake Success, New York
- Hospital for Special SurgeryNew York, New York
- Cleveland ClinicCleveland, Ohio