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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):
Cord Sunderkötter, University Hospital Muenster

Tracking Information
First Submitted Date March 18, 2013
First Posted Date March 20, 2013
Last Update Posted Date December 2, 2015
Study Start Date January 2011
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 18, 2013)
Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis [ Time Frame: 10 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title IgA-positive Versus IgA-negative Immune Complex Vasculitis
Official Title Retrospective Analysis of Frequency of Systemic Involvement in IgA-positive Cutaneous Immune Complex Vasculitis Versus IgA-negative Cutaneous Immune Complex Vasculitis
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Cutaneous Vasculitis
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 18, 2013)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • histologically proven leukocytoclastic vasculitis
  • clinically palpable purpura

Exclusion Criteria:

  • no histological confirmation
  • relevant data missing in file
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01815190
Other Study ID Numbers 2011-040-f-S
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cord Sunderkötter, University Hospital Muenster
Study Sponsor University Hospital Muenster
Collaborators Not Provided
Investigators
Principal Investigator: Cord Sunderkoetter, Prof Dr MD Department of Dermatology, Univ Hospital of Muenster
PRS Account University Hospital Muenster
Verification Date November 2015