IgA-positive Versus IgA-negative Immune Complex Vasculitis

NCT01815190 | Unknown

• 1 other identifier: 2011-040-f-S
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Vasculitis

Keywords

immune complex vasculitis; cutaneous vasculitis; IgA vasculitis; IgA nephropathy

Outcome Measures

Primary Outcomes (1)

• Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis

  10 years

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• histologically proven leukocytoclastic vasculitis
• clinically palpable purpura

You may not qualify if:

• no histological confirmation
• relevant data missing in file

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Department of Dermatology, Univ hospital of Muenster

Münster, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Skin Diseases, Vascular; IgA Vasculitis; Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Immune Complex Diseases; Hypersensitivity; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases

Study Officials

• Cord Sunderkoetter, Prof Dr MD

  Department of Dermatology, Univ Hospital of Muenster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cord Sunderkötter, Prof Dr MD

CONTACT

+49 251 8357481; cord.sunderkoetter@ukmuenster.de

Ilka Herrgott, MD

CONTACT

+49 251 8356502

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: January 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

DE (1)