A Study In Adults With Moderate To Severe Dermatomyositis

Launched by PFIZER · Jun 7, 2017

Keywords

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Eligibility criteria

• Inclusion Criteria for Patients with Skin Predominant Activity:
• • 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 8 biopsies during the course of the research study
• Inclusion Criteria for Patients with Muscle Predominant Activity:
• • MMT-8 ≤136/150 and PhGA, VAS ≥3 cm (0-10 cm) by visual analog scale (VAS)
• • Sum of PhGA, VAS, PtGA, and extramuscular global assessment VAS scores is ≥10 cm (0-10 cm) VAS for each.
• • Participant has failed at least two or more adequate courses of an immunosuppressive agent or immunomodulatory agent, including IVIG, at a dose known to be effective for rheumatologic diseases.
• Exclusion Criteria for Patients with Skin Predominant Activity:
• • 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
• Exclusion Criteria for Patients with Muscle Predominant Activity:
• • Similar to patients with skin predominant activity; Intake of \>20 mg oral prednisone/day, or equivalent