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Profiling Urticaria for the Identification of Subtypes (PURIST)

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ClinicalTrials.gov Identifier: NCT01637116
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Marcus Maurer, Charite University, Berlin, Germany

Tracking Information
First Submitted Date August 15, 2011
First Posted Date July 10, 2012
Last Update Posted Date July 28, 2015
Study Start Date July 2011
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 6, 2012)
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01637116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 6, 2012)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Profiling Urticaria for the Identification of Subtypes
Official Title Profiling Urticaria for the Identification of Subtypes
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 Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition
  • Non-autoreactive Chronic Spontaneous Urticaria
  • Autoimmune Chronic Spontaneous Urticaria
  • Autoreactive, Non-autoimmune Chronic Spontaneous Urticaria
Intervention Not Provided
Study 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 27, 2015)
195
Original Estimated Enrollment
 (submitted: July 6, 2012)
237
Actual Study Completion Date June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01637116
Other Study ID Numbers PURIST
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Marcus Maurer, Charite University, Berlin, Germany
Study Sponsor Marcus Maurer
Collaborators Not Provided
Investigators
Principal Investigator: Marcus Maurer, Prof. Dr. med. Charite-Universitätsmedizin Berlin
PRS Account Charite University, Berlin, Germany
Verification Date July 2015