A Study In Adults With Moderate To Severe Dermatomyositis



Status:Recruiting
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 80
Updated:2/8/2019
Start Date:January 23, 2018
End Date:March 25, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS

A Study looking at Investigational drug and Placebo administered to adult Patients with
moderate to severe Dermatomyositis


Inclusion Criteria:

- 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:

- 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
We found this trial at
22
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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Birmingham, Alabama 35249
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75 Francis Street
Boston, Massachusetts 02115
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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243 6100 South
Murray, Utah 84107
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462 1st Avenue
New York, New York 10010
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85054
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Saint Louis, Missouri 63110
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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100 Mario Capecchi Drive
Salt Lake City, Utah 84112
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Scottsdale, Arizona 85259
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Stanford, California 94305
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