IgA-positive Versus IgA-negative Immune Complex Vasculitis

Cutaneous Vasculitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01815190
• Other study ID #: 2011-040-f-S
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2013
• Last updated: November 30, 2015
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: University Hospital Muenster
• Contact: Cord Sunderkötter, Prof Dr MD
• Phone: +49 251 8357481
• Email: cord.sunderkoetter[@]ukmuenster.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically proven leukocytoclastic vasculitis

• clinically palpable purpura

Exclusion Criteria:

• no histological confirmation

• relevant data missing in file

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cutaneous Vasculitis
• Vasculitis

Locations

Country	Name	City	State
Germany	Department of Dermatology, Univ hospital of Muenster	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis		10 years	No