Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005239

Trial Description

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Title

Profiling Urticaria for the Identification of Subtypes

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Trial Acronym

PURIST

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005239
  •   2013/09/09
  •   2011/08/15
  •   yes
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Secondary IDs

  •   NCT01637116  (ClinicalTrials.gov)
  •   PURIST  (Marcus Maurer)
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Health Condition or Problem studied

  •   Non-autoreactive Chronic Spontaneous Urticaria
  •   Autoimmune Chronic Spontaneous Urticaria
  •   Autoreactive, Non-autoimmune Chronic Spontaneous Urticaria
  •   L50 -  Urticaria
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- 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

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/07/31
  •   237
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Marcus Maurer
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    • Charite-Universitätsmedizin Berlin
    • Marcus Maurer, Prof. Dr. med. 
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    • Marcus Maurer, Prof. Dr.med. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.