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A Study In Adults With Moderate To Severe Dermatomyositis

Last updated on July 11, 2019

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Study Location
Mayo Clinic Florida
Jacksonville, Florida, 32224 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dermatomyositis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Must have CDASI Activity score of greater than or equal to 14, and have failed at
least 1 standard of care systemic treatment, (eg, corticosteroids).

- Confirmation of DM by the investigator and two of the following:

1. Gottron's papules;

2. Gottron's sign;

3. Heliotrope eruption;

4. Nailfold changes, (dilated capillary loops, capillary dropout, cuticular
hypertrophy and/or rugged cuticles;

5. Photodistributed violaceous erythema, (skin that is exposed to sunlight and
appears purplish/reddish, and patchy in appearance;

6. Positive DM serology -

- Post DM diagnosis; standard of care workup for DM must have been completed prior to
entry into this research study.

- Willing to provide 6 biopsies during the course of the research study

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Investigator site staff or members of their family.

- Acute and Chronic present medical conditions

- Intake of greater than 15 mg of prednisone or equivalent per day

- Pregnant or breastfeeding females. Fertile men and women who will not comply with the
use of 2 effective birth control methods as per the research protocol

- Have required management of acute or chronic infections

- Have pre existing demyelinating disorder such as multiple sclerosis, or other severe
neurological deficits.

- Clinically significant lab abnormalities

- Any health condition that may be worsened by immunosuppression

NCT03181893
Pfizer
Recruiting
A Study In Adults With Moderate To Severe Dermatomyositis

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Dermatomyositis
NCT03181893
All Genders
18+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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