What is the mechanism of action of this treatment?

Common treatments for Polyarteritis Nodosa (PAN) include immunosuppressive and anti-inflammatory medications. Cyclophosphamide inhibits DNA replication in rapidly dividing cells, including immune cells, thereby reducing the immune response. Glucocorticoids, like prednisone, suppress various inflammatory pathways and cytokine production to decrease inflammation. These mechanisms are vital for PAN patients as they help control the disease, alleviate symptoms, and prevent further vascular damage.

What side effects are associated with this type of intervention?

Common treatments for Polyarteritis Nodosa include cyclophosphamide, glucocorticoids, and rituximab. Cyclophosphamide can cause side effects such as nausea, vomiting, hair loss, and increased risk of infections due to bone marrow suppression. Glucocorticoids are associated with weight gain, hypertension, diabetes, osteoporosis, and increased susceptibility to infections. Rituximab may lead to infusion reactions, including fever, chills, and respiratory symptoms, as well as an increased risk of infections.

What prior FDA approvals exist?

For the treatment of Polyarteritis Nodosa (PAN), the FDA has approved the use of corticosteroids and immunosuppressive agents such as cyclophosphamide. Additionally, biologics like rituximab, which targets B-cells, have been utilized in the management of vasculitis, including PAN. These treatments aim to reduce inflammation and suppress the immune system to prevent further vascular damage.

What other types of research exist?

Promising novel alternatives for treating Polyarteritis Nodosa in 2024 include biological agents such as Rituximab, Infliximab, and Mycophenolate Mofetil. These agents have shown success in treating small vessel vasculitides and systemic lupus erythematosus, indicating potential efficacy for PAN.

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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

Must not have

Hypocomplementemic urticarial vasculitis, cryoglobulinemic vasculitis, and other known secondary skin vasculitides

Presence of significant extra-cutaneous manifestations suggestive of systemic vasculitis or more diffuse condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at months 1, 3, 6, 9, and 12.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing three different drugs to find the best treatment for patients with isolated skin vasculitis. The drugs help by reducing inflammation and controlling the immune system.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a specific type of skin inflammation related to immune system issues.

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I have symptoms outside my skin suggesting a widespread inflammation in my blood vessels.

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I have been diagnosed with vasculitis affecting organs other than just my skin.

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I have had cancer or been treated for cancer in the last 5 years.

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I have a serious infection that is not under control.

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I am unable to give consent for medical procedures.

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I cannot take or have not responded to two or three of the drugs in this study.

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I have a G6PD deficiency or a history of hemolytic anemia.

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My body has low or no TPMT enzyme activity.

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My liver is not working well, with tests showing more than double the normal limits.

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My kidneys are not working well, with a creatinine clearance below 60 mL/min.

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I have severe or noticeable symptoms of anemia or my hemoglobin is below 10 g/dL.

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I may need prednisone occasionally for another health issue.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at months 1, 3, 6, 9, and 12. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of the study drugs for the treatment of skin vasculitis.

Secondary study objectives

Health-related quality of life

Patient's global assessment of response

Physician's global assessment of response

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Dapsone

2008

Completed Phase 4

~260

Azathioprine

2002

Completed Phase 4

~2340

Colchicine

2014

Completed Phase 4

~18130

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Polyarteritis Nodosa (PAN) include immunosuppressive and anti-inflammatory medications. Cyclophosphamide inhibits DNA replication in rapidly dividing cells, including immune cells, thereby reducing the immune response. Glucocorticoids, like prednisone, suppress various inflammatory pathways and cytokine production to decrease inflammation. These mechanisms are vital for PAN patients as they help control the disease, alleviate symptoms, and prevent further vascular damage.

Pediatric vasculitis.Evidence-based management of ANCA vasculitis.