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Profiling Urticaria for the Identification of Subtypes (PURIST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Marcus Maurer, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01637116
First received: August 15, 2011
Last updated: February 14, 2013
Last verified: February 2013
  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 Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Results of the ASST [ Time Frame: 21 days per patient ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 237
Study Start Date: July 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637116

Contacts
Contact: Marcus Maurer, Prof. Dr.med. +49 30 450 518 043 marcus.maurer@charite.de
Contact: Nicole Schoepke, Dr.med. nicole.schoepke@charite.de

Locations
Germany
University of Berlin Charité Recruiting
Berlin, Germany, 10117
Contact: Marcus Maurer, Prof.Dr.med.    +4930450518043    marcus.maurer@charite.de   
Contact: Nicole Schoepke, Dr.med.       nicole.schoepke@charite.de   
Sponsors and Collaborators
Marcus Maurer
Investigators
Principal Investigator: Marcus Maurer, Prof. Dr. med. Charite-Universitätsmedizin Berlin
  More Information

No publications provided

Responsible Party: Marcus Maurer, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01637116     History of Changes
Other Study ID Numbers: PURIST
Study First Received: August 15, 2011
Last Updated: February 14, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 10, 2014