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Immunosuppressant
Treatments Comparison for Skin Vasculitis (ARAMIS Trial)
Phase 2
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with primary skin vasculitis, not associated with significant extra-cutaneous involvement requiring specific immunosuppressive therapy
Diagnosis of isolated cutaneous small vessel (SV) or medium-sized vessel (MV) vasculitis, cutaneous polyarteritis nodosa (PAN), or IgA vasculitis without active and/or progressing renal involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at months 1, 3, 6, 9, and 12.
Awards & highlights
ARAMIS Trial Summary
This trial is testing which of three different treatments is best for patients with skin vasculitis.
Who is the study for?
Adults with isolated skin vasculitis, confirmed by biopsy, lasting at least 1 month or having multiple flares. Eligible participants have primary skin vasculitis without serious extra-skin symptoms and may have used steroids before joining. Excluded are those with contraindications to the study drugs, systemic vasculitis signs, active cancer in the last 5 years, severe infections or organ insufficiency.Check my eligibility
What is being tested?
The trial is testing three treatments for skin vasculitis: Colchicine, Dapsone, and Azathioprine. It's a multi-center study where patients are randomly assigned to receive one of these standard care options to compare their effectiveness.See study design
What are the potential side effects?
Possible side effects include digestive issues (like diarrhea from Colchicine), blood disorders (such as anemia from Dapsone), liver toxicity (from Azathioprine), and increased risk of infection due to immune system suppression.
ARAMIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a skin condition without serious effects on other body parts.
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I have a specific type of skin vasculitis without kidney problems.
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My vasculitis was confirmed by a skin biopsy.
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I have had skin inflammation for at least a month or multiple times in the last six months.
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I am 18 years old or older.
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I currently have skin vasculitis lesions.
ARAMIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at months 1, 3, 6, 9, and 12.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at months 1, 3, 6, 9, and 12.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of the study drugs for the treatment of skin vasculitis.
Secondary outcome measures
Health-related quality of life
Patient's global assessment of response
Physician's global assessment of response
+2 moreARAMIS Trial Design
2Treatment groups
Experimental Treatment
Group I: Stage 2Experimental Treatment3 Interventions
If the patient has to discontinue the study drug within the (stage 1) 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, colchicine 0.6 mg x 2/day; dapsone 150 mg/day; azathioprine 2 mg/kg/day) for 6 months. Endpoint in this second stage will again be the response to treatment at 6 months.
Group II: Stage 1Experimental Treatment3 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine
2020
Completed Phase 4
~12140
Dapsone
2008
Completed Phase 4
~260
Azathioprine
2002
Completed Phase 4
~2340
Find a Location
Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,086,755 Total Patients Enrolled
5 Trials studying Polyarteritis Nodosa
6,157 Patients Enrolled for Polyarteritis Nodosa
Office of Rare Diseases (ORD)NIH
43 Previous Clinical Trials
12,239 Total Patients Enrolled
3 Trials studying Polyarteritis Nodosa
2,107 Patients Enrolled for Polyarteritis Nodosa
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,119 Total Patients Enrolled
9 Trials studying Polyarteritis Nodosa
3,709 Patients Enrolled for Polyarteritis Nodosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take or have not responded to two or three of the drugs in this study.I have a G6PD deficiency or a history of hemolytic anemia.My kidneys are not working well, with a creatinine clearance below 60 mL/min.I have a specific type of skin inflammation related to immune system issues.I have symptoms outside my skin suggesting a widespread inflammation in my blood vessels.I have been diagnosed with vasculitis affecting organs other than just my skin.I have had cancer or been treated for cancer in the last 5 years.I have a serious infection that is not under control.I am unable to give consent for medical procedures.My body has low or no TPMT enzyme activity.I may need prednisone occasionally for another health issue.I am 18 years old or older.I have a specific type of skin vasculitis without kidney problems.I have a skin condition without serious effects on other body parts.My vasculitis was confirmed by a skin biopsy.I have had skin inflammation for at least a month or multiple times in the last six months.I have not had any reactions or been treated with the study's drugs before.My liver is not working well, with tests showing more than double the normal limits.I have taken steroids for skin inflammation before joining this study.I have severe or noticeable symptoms of anemia or my hemoglobin is below 10 g/dL.I currently have skin vasculitis lesions.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1
- Group 2: Stage 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Colchicine been federally sanctioned for use?
"Colchicine is a medication that has been found to be safe in Phase 2 trials but there is no data currently supporting that it is an effective treatment."
Answered by AI
Are there other examples of Colchicine being used in a medical setting?
"As of right now, there are 56 clinical trials studying Colchicine. 20 of those active trials are in their third and final stage. While the majority of these studies originate from Nashville, Tennessee, there are 398 locations across the world conducting research on this medication."
Answered by AI
How many research subjects are included in the data pool for this investigation?
"In order to run this experiment, we need 90 individuals that fit the bill. If you are eligible and interested in helping out, you can go to University of Kansas Medical Center in Kansas City or St. Joseph's Healthcare in Hamilton."
Answered by AI
How many research facilities are testing this hypothesis?
"Currently, there are 7 clinical trial sites operational. These locations include Kansas City, Hamilton and Montréal as well as 4 other undisclosed cities. To cut down on participant burden, it is recommended to choose the medical centre closest to you."
Answered by AI
Are research participants still being recruited for this trial?
"This study is looking for patients, according to the information on clinicaltrials.gov. The clinical trial was posted on 1/1/2017 and edited on 1/25/2022."
Answered by AI
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