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IgA-positive Versus IgA-negative Immune Complex Vasculitis

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ClinicalTrials.gov Identifier: NCT01815190
Recruitment Status : Unknown
Verified November 2015 by Cord Sunderkötter, University Hospital Muenster.
Recruitment status was:  Recruiting
First Posted : March 20, 2013
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Cutaneous Vasculitis

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Frequency of Systemic Involvement in IgA-positive Cutaneous Immune Complex Vasculitis Versus IgA-negative Cutaneous Immune Complex Vasculitis
Study Start Date : January 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis [ Time Frame: 10 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

  • histologically proven leukocytoclastic vasculitis
  • clinically palpable purpura

Exclusion Criteria:

  • no histological confirmation
  • relevant data missing in file
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815190


Contacts
Contact: Cord Sunderkötter, Prof Dr MD +49 251 8357481 cord.sunderkoetter@ukmuenster.de
Contact: Ilka Herrgott, MD +49 251 8356502

Locations
Germany
Department of Dermatology, Univ hospital of Muenster Recruiting
Muenster, Germany, 48149
Contact: Cord Sunderkoetter, Prof Dr MD    +492518357481    cord.sunderkoetter@ukmuenster.de   
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Cord Sunderkoetter, Prof Dr MD Department of Dermatology, Univ Hospital of Muenster
More Information

Responsible Party: Cord Sunderkötter, Professor Dr, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01815190     History of Changes
Other Study ID Numbers: 2011-040-f-S
First Posted: March 20, 2013    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Cord Sunderkötter, University Hospital Muenster:
immune complex vasculitis
cutaneous vasculitis
IgA vasculitis
IgA nephropathy

Additional relevant MeSH terms:
Vasculitis
Skin Diseases, Vascular
Vascular Diseases
Cardiovascular Diseases
Skin Diseases
Antigen-Antibody Complex
Immunologic Factors
Physiological Effects of Drugs