IgA-positive Versus IgA-negative Immune Complex Vasculitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Hospital Muenster
Sponsor:
Information provided by (Responsible Party):
Cord Sunderkötter, University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01815190
First received: March 18, 2013
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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
Cutaneous Vasculitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cord Sunderkötter, Professor Dr, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01815190     History of Changes
Other Study ID Numbers: 2011-040-f-S
Study First Received: March 18, 2013
Last Updated: March 21, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by 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
Immunoglobulin A
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014