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Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT02945345
Collaborator
(none)
300
Enrollment
1
Location
199.1
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Jun 1, 2008
    Anticipated Primary Completion Date :
    Jan 2, 2025
    Anticipated Study Completion Date :
    Jan 2, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Cutaneous Dermatomyositis Disease Area and Severity Index [through study completion, an average of 1 year]

      Disease severity tool

    Secondary Outcome Measures

    1. Skin quality of life tool [through study completion, an average of 1 year]

      Quality of life tool

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Victoria Werth, MD and Principal Investigator, University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT02945345
    Other Study ID Numbers:
    • 808230
    First Posted:
    Oct 26, 2016
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:
    Dermatomyositis

    Study Results

    No Results Posted as of Feb 1, 2022