Profiling Urticaria for the Identification of Subtypes

Completed

• Conditions: Non-autoreactive Chronic Spontaneous Urticaria; Autoimmune Chronic Spontaneous Urticaria; Autoreactive, Non-autoimmune Chronic Spontaneous Urticaria

• Registration Number: NCT01637116
• Lead Sponsor: Marcus Maurer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-10
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

• chronic spontaneous urticaria
• disease duration > 6 weeks
• signed and dated informed consent
• age 18 years or older
• Non sedating antihistamines may be used on an "on demand" basis throughout the study, in case of high urticaria activity [>50 wheals, and intense pruritus: urticaria activity score (UAS) of 6] or in case of an emergency. Patients may take either cetirizine 10 mg up to a maximum of 4 tablets per 24 hours or fexofenadine 180 mg up to a maximum of 4 tablets per 24 hours. The use of antihistamines and the reason has to be documented by the patient in the patient diary. Patients should avoid the use of antihistamines during the study and especially during the three days prior to skin testing
• for female with childbearing potential: female will have to use a safe method of contraception to prevent pregnancy and will have to agree to continue this method of contraception during the whole study.

Exclusion Criteria

• intake of immunosuppressives 3 month before Screening Visit and during the course of the study. Immunosuppressives including ciclosporin, methotrexate, mycophenolate, azathioprine and cyclophosphamide need to be stopped at least 3 month before Screening Visit
• intake of corticosteroids (e.g. oral, injection) 1 month before Screening Visit and during the course of the study. Corticosteroids need to be stopped at least 1 month before the Screening Visit.
• Previous or present treatment with anti-IgE-antibodies including omalizumab (Xolair)
• age below 18 years
• use of tricyclic antidepressants (e.g. amitriptyline), doxepin, leukotriene antagonists (e.g. montelukast, trade name: singulair), H2 antihistamines (e.g. cimetidine, famotidine, ranitidine), sulphasalazine, dapsone, tranexamic acid, warfarin, heparin during the last 4 weeks before the Screening Visit and during the course of the study.
• pregnancy, lactation or planned pregnancy during the study
• mentally incapacitated subjects
• patients protected by the law (adults under guardianship, or hospitalized in a public or private institution for a reason other than the study, or incarcerated)
• patients suffering from urticaria vasculitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Results of a cell activating assay (BHRA)	21 days per patient	to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria
Results of the ASST	21 days per patient	to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria
Results of autoantibody-test (anti-IgE and anti-FcRI)	21 days per patient	to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria

Secondary Outcome Measures

Name	Time	Method
Results of Urticaria activity score (UAS7)	21 days per patient	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
Results of HRQoL scores (CU-Q2oL, DLQI)	21 days per patient	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
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)	21 days per patient	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

Trial Locations

Locations (1)

University of Berlin Charité; 🇩🇪 Berlin, Germany