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

Recruiting

• Conditions: Dermatomyositis

• Registration Number: NCT02945345
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04
• Primary Completion: 2025-01-02
• Study Completion: 2025-01-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cutaneous Dermatomyositis Disease Area and Severity Index	through study completion, an average of 1 year	Disease severity tool

Secondary Outcome Measures

Name	Time	Method
Skin quality of life tool	through study completion, an average of 1 year	Quality of life tool

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States