NCT02945345

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jun 2008Jan 2030

Study Start

First participant enrolled

June 1, 2008

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2012

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2030

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

21.6 years

First QC Date

February 9, 2012

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cutaneous Dermatomyositis Disease Area and Severity Index

    Disease severity tool

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Skin quality of life tool

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients who have been diagnosed with dermatomyositis.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, skin tissue biopsies

MeSH Terms

Conditions

Dermatomyositis

Condition Hierarchy (Ancestors)

PolymyositisMyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD and Principal Investigator

Study Record Dates

First Submitted

February 9, 2012

First Posted

October 26, 2016

Study Start

June 1, 2008

Primary Completion (Estimated)

January 2, 2030

Study Completion (Estimated)

January 2, 2030

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations