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Autoimmune Blistering Diseases Study (AIBD)

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ClinicalTrials.gov Identifier: NCT02753777
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
VICTORIA WERTH, University of Pennsylvania

April 20, 2016
April 28, 2016
November 15, 2016
April 2016
December 2018   (Final data collection date for primary outcome measure)
  • Pemphigus Disease Area Index (PDAI) [ Time Frame: one year ]
  • Bullous Pemphigoid Disease Area Index (BPDAI) [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT02753777 on ClinicalTrials.gov Archive Site
  • Autoimmune Bullous Disease Quality of Life (ABQOL) [ Time Frame: one year ]
  • Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) [ Time Frame: one year ]
  • Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) [ Time Frame: one year ]
Same as current
Not Provided
Not Provided
 
Autoimmune Blistering Diseases Study
Prevalence and Clinical Severity of Autoimmune Blistering Diseases
Pemphigus and bullous pemphigoid (BP) are severe autoimmune blistering diseases (AIBD) that pose a critical need for new therapeutic approaches. Clinical trials in pemphigus and BP will require the availability of validated disease severity measures that can be used to define primary outcomes.

The disease severity instruments for pemphigus and BP, the Pemphigus Disease Area Index (PDAI) and the Bullous Pemphigoid Disease Area Index (BPDAI), respectively, have the potential to capture changes in all grades of disease activity, including mild disease, and therefore represent a substantial improvement over simple lesion counts or measurements of affected body surface area. However, full validation of the PDAI and BPDAI for use in clinical trials will require additional and more extensive measurements that will enable us to classify patients correctly by disease severity and define the minimal change in score that is clinically significant.

This database study will compare the Pemphigus Disease Area and Severity Index (PDAI) and the Bullous Pemphigoid Disease Area Index (BPDAI) against other disease severity measures, including the Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) and a physician's global assessment. Additionally, patients will be asked to rate their overall disease severity using a visual analogue scale, the patient's global assessment. Participants will also have the option to donate blood samples to our AIBD blood bank for immunologic and pathophysiologic studies.

The purpose of this database study will also be to evaluate quality of life (QoL) measures and correlate these QoL measures with disease severity in patients with pemphigus and BP. QoL is an important and independent component of disease impact on patients. This database study will use the following QoL measures: the SF-36, which is a nonspecific QoL measure; the Skindez-29 and the Dermatology Life Quality Index (DLQI), which are dermatology-specific instruments; the Autoimmune Bullous Disease Quality of Life (ABQOL) and Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) questionnaires, which are AIBD-specific tools. The results will be utilized in planning future clinical studies.

The AIBD study will be conducted only at Penn at this time. Data from the study will be entered into a password protected, web-based database that is used only at Penn.

Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
3 Years
Retention:   Samples With DNA
Description:
Blood specimens will be collected during regularly scheduled clinic visits. The specimens will be processed and stored at the research labs belonging to the principal investigator at the University of Pennsylvania and the Philadelphia VA Medical Center. The specimens will not be publicly available and will be coded and stored in a locked facility equipped with a freezer.
Non-Probability Sample
Adult patients over the age of 18 who have been diagnosed with pemphigus vulgaris, pemphigus foliaceus or bullous pemphigoid.
  • Pemphigus Vulgaris
  • Pemphigus Foliaceus
  • Bullous Pemphigoid
Other: Questionnaires
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Same as current
April 2019
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gender/Age: Males or females above 18 years old
  • Diagnosis: pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid
  • Subjects able to give informed consent

Exclusion Criteria:

  • Patients who are under age 18 years.
  • Patients without pemphigus or pemphigoid diseases
  • Penn employees
  • Penn students
  • Cognitively impaired persons
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Victoria P Werth, MD 215-615-2940 werth@mail.med.upenn.edu
Contact: Joyce Okawa, RN 215-615-2960 Joyce.Okawa@uphs.upenn.edu
United States
 
 
NCT02753777
824790
No
Not Provided
Plan to Share IPD: No
VICTORIA WERTH, University of Pennsylvania
University of Pennsylvania
Not Provided
Not Provided
University of Pennsylvania
November 2016