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Trial record 1 of 1 for:    Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
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Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) (CDASI)

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ClinicalTrials.gov Identifier: NCT02945345
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Victoria Werth, University of Pennsylvania

Brief Summary:

The Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), established in 2008, is a one-site database study conducted at the University of Pennsylvania. The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, including psychological responses, treatments and quality of life associated with dermatomyositis. The CDASI database incorporates the Cutaneous Dermatomyositis Disease Area and Severity Index), a validated outcome measure of disease responsiveness in patients, and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with dermatomyositis.

The CDASI database has led to publication of comparison studies of CDASI and other clinical instruments and the effect of dermatomyositis on Quality of Life (QoL).

The CDASI database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease. Data will be analysed over a 5 years.


Condition or disease
Dermatomyositis

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
Actual Study Start Date : June 2008
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025





Primary Outcome Measures :
  1. Cutaneous Dermatomyositis Disease Area and Severity Index [ Time Frame: through study completion, an average of 1 year ]
    Disease severity tool


Secondary Outcome Measures :
  1. Skin quality of life tool [ Time Frame: through study completion, an average of 1 year ]
    Quality of life tool


Biospecimen Retention:   Samples With DNA
Blood, skin tissue biopsies


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients who have been diagnosed with dermatomyositis.
Criteria

Inclusion Criteria:

  • Gender/Age: Males or females above 18 years old
  • Diagnosis: Cutaneous Dermatomyositis
  • Subjects able to give informed consent

Exclusion Criteria:

  • Subjects without cutaneous DM
  • Penn employees
  • Penn students
  • Cognitively impaired persons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945345


Contacts
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Contact: Victoria Werth, MD 215-615-2940 werth@pennmedicine.upenn.edu
Contact: Joyce Okawa, RN 215-615-2940 joyce.okawa@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Victoria P Werth, MD    215-615-2940    werth@pennmedicine.upenn.edu   
Contact: Joyce Okawa, RN    215-615-2940    joyce.okawa@pennmedicine.upenn.edu   
Principal Investigator: Victoria P Werth, MD         
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: Victoria Werth, MD and Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02945345    
Other Study ID Numbers: 808230
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases