IgA-positive Versus IgA-negative Immune Complex Vasculitis

NCT ID: NCT01815190

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cutaneous Vasculitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IgA-positive vasculitis

Patients with immune complex vasculitis who show perivascular deposits of IgA

No interventions assigned to this group

IgA-negative vasculitis

Patients with immune complex vasculitis who show no perivascular deposits of IgA

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* histologically proven leukocytoclastic vasculitis
* clinically palpable purpura

Exclusion Criteria

* no histological confirmation
* relevant data missing in file
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Cord Sunderkötter

Professor Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cord Sunderkoetter, Prof Dr MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Univ Hospital of Muenster

Locations

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Department of Dermatology, Univ hospital of Muenster

Münster, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Cord Sunderkötter, Prof Dr MD

Role: CONTACT

+49 251 8357481

Ilka Herrgott, MD

Role: CONTACT

+49 251 8356502

Facility Contacts

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Cord Sunderkoetter, Prof Dr MD

Role: primary

+492518357481

Other Identifiers

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2011-040-f-S

Identifier Type: -

Identifier Source: org_study_id