IgA-positive Versus IgA-negative Immune Complex Vasculitis

• Conditions: Cutaneous Vasculitis

• Registration Number: NCT01815190
• Lead Sponsor: University Hospital Muenster

Brief Summary

Cutaneous vasculitis due to vascular deposition of large circulating immune complexes is a disease frequently seen by general practitioners and dermatologists. The clinical symptom is palpable purpura with predilection for the lower legs.

In some cases vasculitis also affects systemic organs, such as the kidneys and the intestine.

When the immune complexes contain immunoglobulin class A (IgA) and when there is systemic involvement, the disease has been referred to as Henoch Schönlein purpura.

When there are no signs of systemic involvement, the disease has been referred to as cutaneous leukocytoclastic angiitis.

The investigators hypothesize that palpable purpura with predilection for lower legs is a pathognomonic clinical sign for immune complex vasculitis in both IgA vasculitis and IgA-negative vasculitis, but that only the presence of IgA in immune complexes is likely to be associated with systemic involvement and therefore warrants more extensive diagnostic procedures Vice versa the investigators postulate that the presence of IgG or IgM without IgA in immune complexes excludes systemic involvement The investigators also want to investigate to which of the 2 groups patients with palpable purpura and negative immunofluorescence should be assigned.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-20
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• histologically proven leukocytoclastic vasculitis
• clinically palpable purpura

Exclusion Criteria

• no histological confirmation
• relevant data missing in file

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis	10 years

Trial Locations

Locations (1)

Department of Dermatology, Univ hospital of Muenster; 🇩🇪 Muenster, Germany