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 |
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
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
sites
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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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
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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75 Francis Street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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New York University School of Medicine NYU School of Medicine has a proud history that...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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