Interventions for preventing and treating kidney disease in IgA vasculitis.
Deirdre Hahn, Elisabeth M Hodson, Jonathan C Craig
https://pubmed.ncbi.nlm.nih.gov/36853224Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID02939573
A Randomized Multicenter Study Comparing Colchicine, Dapsone, and Azathioprine for Isolated Skin Vasculitis
Led by University of Pennsylvania · Updated on 2026-01-23
90
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of three standard medications—colchicine, dapsone, and azathioprine—in treating patients with isolated skin vasculitis. This randomized, multicenter trial aims to compare these treatments over a two-stage process, focusing on patients with skin-limited vasculitis conditions such as small or medium vessel vasculitis, cutaneous polyarteritis nodosa, and IgA vasculitis without significant kidney involvement. The study is sponsored by the University of Pennsylvania and is conducted as a Phase 2 trial. Participants are initially randomized to receive one of the three study drugs for six months. The primary endpoint is the response to treatment at six months. If a participant needs to stop their assigned medication due to lack of response, disease flare, or side effects within the first six months or during follow-up up to twelve months, they will be re-randomized to one of the remaining two drugs for an additional six months. Response to therapy is evaluated again at the end of this second stage. During the study, participants will undergo regular assessments including physician and patient global response evaluations, quality of life measurements, and specific skin-related questionnaires at multiple time points up to twelve months. Researchers will monitor treatment response at months 3, 6, 9, and 12, with safety and side effects carefully observed. Total participation can last up to one year, with ongoing follow-up to assess the effectiveness and tolerability of the study medications.
CONDITIONS
Brief Title
A Randomized Multicenter Study for Isolated Skin Vasculitis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of isolated cutaneous small or medium-sized vessel vasculitis, cutaneous polyarteritis nodosa, or IgA vasculitis without active kidney involvement
- Diagnosis confirmed by skin biopsy including immunofluorescence study for small vessel vasculitis
- Active skin vasculitis lasting at least 1 month or at least 2 flares in the past 6 months
- Active skin lesions at the time of enrollment (excluding healing or post-inflammatory lesions)
- Patients may have contraindications or prior treatment failure with one study drug and can enter directly into stage 2 (capped at 10% of enrollment)
- Prednisone users must taper off within 6 weeks after starting study drug unless on stable low dose for other conditions
- Ability to provide informed consent
You will not qualify if you...
- Presence of significant systemic vasculitis or diffuse disease requiring immunosuppressive therapy
- Known systemic vasculitis conditions such as granulomatosis with polyangiitis, eosinophilic granulomatosis, cryoglobulinemic vasculitis, systemic polyarteritis nodosa, CNS vasculitis, or positive ANCA
- Secondary skin vasculitis due to autoimmune diseases, cancer, hematologic disorders, active infection, or medications
- History of serious allergy or intolerance to study drugs (except for direct entry into stage 2, capped at 10%)
- Contraindication or failure to respond to two or more study drugs
- Deficiency of glucose-6-phosphate dehydrogenase (G6PD) or history of hemolytic anemia (except for direct entry into stage 2, capped at 10%)
- Low or absent thiopurine methyltransferase (TPMT) activity (if known)
- Significant liver or kidney dysfunction
- Significant anemia (hemoglobin less than 10 g/dL)
- Comorbid conditions likely requiring intermittent prednisone during study
- Active cancer or recent malignancy within 5 years (with some exceptions)
- Active serious infection
- Unable to provide consent
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants are randomized to receive one of three medications (colchicine, dapsone, or azathioprine) for treating isolated skin vasculitis.
Visits at months 0, 1, 3, and 6 for assessments
Treatment
Duration - 6 months
If participants discontinue the first study drug due to lack of response, flare, or side effects, they are re-randomized to one of the two remaining medications for additional treatment.
Visits at months 6, 9, and 12 for assessments
Trial Site Locations
Total: 16 locations
1
University of Kansas Medical Center
Kansas City, Kansas, United States
Actively Recruiting
2
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Completed
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Completed
4
Northwell Health
Lake Success, New York, United States, 11042
Completed
5
Hospital for Special Surgery
New York, New York, United States, 10021
Completed
6
Cleveland Clinic
Cleveland, Ohio, United States
Completed
7
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Completed
8
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
10
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
11
University of Utah
Salt Lake City, Utah, United States
Completed
12
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
13
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Actively Recruiting
14
University of Toronto Mount Sinai Hospital
Toronto, Ontario, Canada
Actively Recruiting
15
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
16
Tohoku Medical and Pharmaceutical University Hospital
Kyoto, Japan, 602-8566
Completed
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Research Team
C
Carol McAlear, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Protocol for a randomized multicenter study for isolated skin vasculitis (ARAMIS) comparing the efficacy of three drugs: azathioprine, colchicine, and dapsone.
Robert G Micheletti, Christian Pagnoux, Roy N Tamura...
https://pubmed.ncbi.nlm.nih.gov/32345372