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The primary purpose of this study is to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria.
Additional aims: include the comparison of the clinical profiles of autoreactive, autoimmune and non autoreactive / autoimmune urticaria and the quality of life impairment in these subsets of chronic spontaneous urticaria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autoimmune chronic spontaneous urticaria | Patients with chronic spontaneous urticaria with a positive ASST, who also test positive in a cell activating assay (BHRA OR CD 63 activation of healthy donor basophils) and who exhibit anti-FcεRI and/or anti-IgE autoantibodies (=autoimmune chronic spontaneous urticaria). | ||
| autoreactive, non-autoimmune chronic spontaneous urticaria | Patients with chronic spontaneous urticaria with a positive ASST, who test negative in cell activation assay or who do not exhibit anti-FcεRI or anti-IgE autoantibodies (=autoreactive, non-autoimmune chronic spontaneous urticaria) | ||
| non-autoreactive chronic spontaneous urticaria | Patients with chronic spontaneous urticaria and a negative ASST (= non-autoreactive chronic spontaneous urticaria) |
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| Measure | Description | Time Frame |
|---|---|---|
| Results of the ASST | to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria | 21 days per patient |
| Results of a cell activating assay (BHRA) | to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria | 21 days per patient |
| Results of autoantibody-test (anti-IgE and anti-FcRI) | to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria | 21 days per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Results of Urticaria activity score (UAS7) | comparison of the clinical profiles of autoreactive, autoimmune and non autoreactive / autoimmune urticaria and the quality of life impairment in these subsets of chronic spontaneous urticaria | 21 days per patient |
| Results of HRQoL scores (CU-Q2oL, DLQI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Maurer, Prof. Dr. med. | Charite-Universitätsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Berlin Charité | Berlin | State of Berlin | 10117 | Germany |
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comparison of the clinical profiles of autoreactive, autoimmune and non autoreactive / autoimmune urticaria and the quality of life impairment in these subsets of chronic spontaneous urticaria |
| 21 days per patient |
| Results of laboratory tests (Thyroid antibodies (anti-TPO +/- anti-thyreoglobulin); ANA; Rheumatoid factor; CRP; ESR; total IgE; T3,T4, TSH, diff BB, Helicobacter pylori stool antigen test or breath test; D-Dimer) | comparison of the clinical profiles of autoreactive, autoimmune and non autoreactive / autoimmune urticaria and the quality of life impairment in these subsets of chronic spontaneous urticaria | 21 days per patient |