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
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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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Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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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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