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Recruiting NCT02945345

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

Observational Dermatomyositis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dermatomyositis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Cutaneous Dermatomyositis Disease Area and Severity Index [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (1)
  • Skin quality of life tool [Time frame: through study completion, an average of 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Hospital of the University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT02945345 · 808230

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗