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

Dermatomyositis Clinical Trial

— CDASI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02945345
• Other study ID #: 808230
• Status: Recruiting
• Start date: June 2008
• Est. completion date: January 2, 2025

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: Victoria Werth, MD
• Phone: 215-615-2940
• Email: werth[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2, 2025
• Est. primary completion date: January 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatomyositis

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutaneous Dermatomyositis Disease Area and Severity Index	Disease severity tool	through study completion, an average of 1 year
Secondary	Skin quality of life tool	Quality of life tool	through study completion, an average of 1 year