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

NCT ID: NCT02945345

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2030-01-02

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.

Conditions

Dermatomyositis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Victoria Werth

MD and Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Victoria Werth, MD

Role: CONTACT

werth@pennmedicine.upenn.edu

215-615-2940

Joyce Okawa, RN

Role: CONTACT

joyce.okawa@pennmedicine.upenn.edu

215-615-2940

Facility Contacts

Victoria P Werth, MD

Role: primary

werth@pennmedicine.upenn.edu

215-615-2940

Joyce Okawa, RN

Role: backup

joyce.okawa@pennmedicine.upenn.edu

215-615-2940

Other Identifiers

808230

Identifier Type: -

Identifier Source: org_study_id