Non-autoreactive Chronic Spontaneous UrticariaPURISTNCT01637116
Profiling Urticaria for the Identification of Subtypes
An observational study of Non-autoreactive Chronic Spontaneous Urticaria and Autoimmune Chronic Spontaneous Urticaria, run by Marcus Maurer at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-autoreactive Chronic Spontaneous Urticaria, Autoimmune Chronic Spontaneous Urticaria, Autoreactive, Non-autoimmune Chronic Spontaneous Urticaria
- How many people
- 195 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of the ASST
to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria
Measured: 21 days per patient
Results of a cell activating assay (BHRA)
to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria
Measured: 21 days per patient
Results of autoantibody-test (anti-IgE and anti-FcRI)
to identify and characterize novel diagnostic markers for autoimmune urticaria, a subset of chronic spontaneous urticaria
Measured: 21 days per patient
Secondary outcomes (3)
Results of Urticaria activity score (UAS7)
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
Measured: 21 days per patient
Results of HRQoL scores (CU-Q2oL, DLQI)
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
Measured: 21 days per patient
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)
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
Measured: 21 days per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJul 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-autoreactive Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcus Maurer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcus Maurer, Charite University, Berlin, Germany
- Investigators
- Marcus Maurer, Prof. Dr. med., Principal investigator, Charite-Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637116
- Sponsor's protocol ID
- PURIST
- Acronym
- PURIST
- Status last verified
- Jul 2015
- First submitted
- 15 Aug 2011
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling Urticaria for the Identification of Subtypes
- ClinicalTrials.gov ID
- NCT01637116
- Acronym / sponsor ID
- PURIST / PURIST
- Conditions
- Non-autoreactive Chronic Spontaneous Urticaria, Autoimmune Chronic Spontaneous Urticaria, Autoreactive, Non-autoimmune Chronic Spontaneous Urticaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Marcus MaurerUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
3 secondary outcomes
Results of Urticaria activity score (UAS7)
Time frame: 21 days per patient
Results of HRQoL scores (CU-Q2oL, DLQI)
Time frame: 21 days per patient
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Maurer, Prof. Dr. med. principal investigator
Charite-Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-autoreactive Chronic Spontaneous Urticaria and Autoimmune Chronic Spontaneous Urticaria, run by Marcus Maurer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of the ASST (time frame: 21 days per patient). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.