Cutaneous VasculitisNCT01815190
IgA-positive Versus IgA-negative Immune Complex Vasculitis
An observational study of Cutaneous Vasculitis, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Vasculitis
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients of the department of dermatology in Muenster with histologically proven leukocytoclastic vasculitis in files in last 10-20 years
Who may be able to join
- histologically proven leukocytoclastic vasculitis
- clinically palpable purpura
Who cannot join
- no histological confirmation
- relevant data missing in file
Trial locations and contacts
1 site in 1 country.
Ilka Herrgott, MD contact
Germany1 site, 1 recruiting
- Recruiting
Department of Dermatology, Univ hospital of Muenster
Münster, 48149
Cord Sunderkoetter, Prof Dr MD, +492518357481, cord.sunderkoetter@ukmuenster.de
About this study
Official title: Retrospective Analysis of Frequency of Systemic Involvement in IgA-positive Cutaneous Immune Complex Vasculitis Versus IgA-negative Cutaneous Immune Complex Vasculitis
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.
Read more
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
- Medical subject headings
- Skin Diseases, Vascular, IgA Vasculitis, Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous VasculitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cord Sunderkötter, University Hospital Muenster
- Investigators
- Cord Sunderkoetter, Prof Dr MD, Principal investigator, Department of Dermatology, Univ Hospital of Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815190
- Sponsor's protocol ID
- 2011-040-f-S
- Status last verified
- Nov 2015
- First submitted
- 18 Mar 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Frequency of Systemic Involvement in IgA-positive Cutaneous Immune Complex Vasculitis Versus IgA-negative Cutaneous Immune Complex Vasculitis
- ClinicalTrials.gov ID
- NCT01815190
- Acronym / sponsor ID
- 2011-040-f-S
- Conditions
- Cutaneous Vasculitis
- Keywords
- immune complex vasculitis, cutaneous vasculitis, IgA vasculitis, IgA nephropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of the department of dermatology in Muenster with histologically proven leukocytoclastic vasculitis in files in last 10-20 years
Key inclusion criteria (2 listed)
- histologically proven leukocytoclastic vasculitis
- clinically palpable purpura
Key exclusion criteria (2 listed)
- no histological confirmation
- relevant data missing in file
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilka Herrgott, MD contact
Cord Sunderkoetter, Prof Dr MD principal investigator
Department of Dermatology, Univ Hospital of Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Vasculitis, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cord Sunderkötter, Prof Dr MD (+49 251 8357481, cord.sunderkoetter@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.