Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT03181893
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03181893
Study Brief:
Protocol Section:
NCT03181893