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

April 2, 2024 updated by: Victoria Werth, University of Pennsylvania

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients who have been diagnosed with dermatomyositis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutaneous Dermatomyositis Disease Area and Severity Index
Time Frame: through study completion, an average of 1 year
Disease severity tool
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin quality of life tool
Time Frame: through study completion, an average of 1 year
Quality of life tool
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2008

Primary Completion (Estimated)

January 2, 2025

Study Completion (Estimated)

January 2, 2025

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimated)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 808230

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dermatomyositis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe