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Profiling Urticaria for the Identification of Subtypes (PURIST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637116
First Posted: July 10, 2012
Last Update Posted: July 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marcus Maurer, Charite University, Berlin, Germany
  Purpose

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.


Condition
Non-autoreactive Chronic Spontaneous Urticaria Autoimmune Chronic Spontaneous Urticaria Autoreactive, Non-autoimmune Chronic Spontaneous Urticaria

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Profiling Urticaria for the Identification of Subtypes

Resource links provided by NLM:


Further study details as provided by Marcus Maurer, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Results of the ASST [ Time Frame: 21 days per patient ]
    to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria

  • Results of a cell activating assay (BHRA) [ Time Frame: 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) [ Time Frame: 21 days per patient ]
    to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria


Secondary Outcome Measures:
  • Results of Urticaria activity score (UAS7) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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


Enrollment: 195
Study Start Date: July 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients with chronic spontaneous urticaria and a negative ASST (= non-autoreactive chronic spontaneous urticaria)
  2. 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).
  3. 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)
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637116


Locations
Germany
University of Berlin Charité
Berlin, Germany, 10117
Sponsors and Collaborators
Marcus Maurer
Investigators
Principal Investigator: Marcus Maurer, Prof. Dr. med. Charite-Universitätsmedizin Berlin
  More Information

Responsible Party: Marcus Maurer, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01637116     History of Changes
Other Study ID Numbers: PURIST
First Submitted: August 15, 2011
First Posted: July 10, 2012
Last Update Posted: July 28, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases