Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid
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ClinicalTrials.gov Identifier: NCT01559155 |
Recruitment Status
: Unknown
Verified March 2016 by Centre Hospitalier Universitaire de Nīmes.
Recruitment status was: Recruiting
First Posted
: March 21, 2012
Last Update Posted
: March 31, 2016
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Tracking Information | ||||
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First Submitted Date | March 19, 2012 | |||
First Posted Date | March 21, 2012 | |||
Last Update Posted Date | March 31, 2016 | |||
Study Start Date | November 2013 | |||
Estimated Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Plasmatic concentration of anti-proteasome autoantibodies (ng/ml) [ Time Frame: baseline ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01559155 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid | |||
Official Title | Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid | |||
Brief Summary | The primary objective of this study is to describe and compare plasmatic anti-proteasome auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an elderly control group. | |||
Detailed Description | The secondary objectives of this study are: To compare the following parameters between the 3 groups:
To explore the potential relationships between:
To characterize plasmatic anti-proteasome auto-antibodies in patients suffering from bullous pemphigoide and other dermatological auto-immune diseases (other bullous auto immune diseases: pemphigus, cutaneous lupus, ...). To characterize the expression and the activity of proteasomes in skin samples, in plasma and in circulating mononuclear cells in patients with bullous pemphigoide. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: All left over plasma samples will be incorporated into the biological collection at the Nîmes University Hospital. |
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Sampling Method | Non-Probability Sample | |||
Study Population | The study population is composed of three groups: (1) 50 patients with newly diagnosed (untreated) bullous pemphigoid, (2) 50 control patients matched for age and sex with the previous group and (3) 30 patients with other dermatological auto-immune disease (15 pemphigus + 15 cutaneous lupus). | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
130 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | November 2016 | |||
Estimated Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
For the bullous pemphigoid group:
For the pemphigus group:
For the lupus group:
For the control group:
Exclusion Criteria:
For patients with bullous pemphigoid, pemphigus or lupus:
For the controls:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01559155 | |||
Other Study ID Numbers | LOCAL/2011/PS-02 2012-A00180-43 ( Other Identifier: RCB number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Centre Hospitalier Universitaire de Nīmes | |||
Study Sponsor | Centre Hospitalier Universitaire de Nīmes | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Centre Hospitalier Universitaire de Nīmes | |||
Verification Date | March 2016 |