A Randomized Multicenter Study for Isolated Skin Vasculitis

Conditions

• Cutaneous Polyarteritis Nodosa
• Henoch-Schönlein Purpura
• IgA Vasculitis
• Primary Cutaneous Vasculitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Colchicine — DRUG
  Randomized to colchicine 0.6 mg x 2/day
• Dapsone — DRUG
  Randomized to dapsone 150 mg/day
• Azathioprine — DRUG
  Randomized to azathioprine 2 mg/kg/day

Study Details

Multi-center sequential multiple assignment randomized trial comparing the effectiveness of three different standard of care treatment options for patients with isolated skin vasculitis.

Key Dates

Start date

Jan 1, 2017

Status verified

Jan 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Stage 1
  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).
• Experimental: Stage 2
  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.

Primary Outcome Measure

Efficacy of the study drugs for the treatment of skin vasculitis. [ Time Frame: Response to therapy at month 6 of the pooled study stages 1 and 2. ]

Central Contacts

• Carol McAlear, MA
  [email protected]

Locations (12)

Find similar trials in Kansas City, KS

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