IgA-positive Versus IgA-negative Immune Complex Vasculitis

Retrospective Analysis of Frequency of Systemic Involvement in IgA-positive Cutaneous Immune Complex Vasculitis Versus IgA-negative Cutaneous Immune Complex Vasculitis

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.

Study Overview

• Status: Unknown
• Conditions: Cutaneous Vasculitis

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Germany
  • Muenster, Germany, 48149
    • Recruiting
    • Department of Dermatology, Univ hospital of Muenster
    • Contact: Cord Sunderkoetter, Prof Dr MD; Phone Number: +492518357481; Email: cord.sunderkoetter@ukmuenster.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients of the department of dermatology in Muenster with histologically proven leukocytoclastic vasculitis in files in last 10-20 years

Description

Inclusion Criteria:

• histologically proven leukocytoclastic vasculitis
• clinically palpable purpura

Exclusion Criteria:

• no histological confirmation
• relevant data missing in file

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
IgA-positive vasculitis; Patients with immune complex vasculitis who show perivascular deposits of IgA
IgA-negative vasculitis; Patients with immune complex vasculitis who show no perivascular deposits of IgA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis	10 years

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Cord Sunderkoetter, Prof Dr MD, Department of Dermatology, Univ hospital of Muenster

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: March 18, 2013
• First Posted (ESTIMATE): March 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: IgA nephropathy; immune complex vasculitis; cutaneous vasculitis; IgA vasculitis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Vasculitis
• Other Study ID Numbers: 2011-040-f-S