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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT03813160
Eligibility Criteria:
Inclusion Criteria:
* Fulfill at least one of the following criteria for dermatomyositis:
1. Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b)
2. ACR/EULAR criteria (Lundberg et al, 2017)
* Disease activity/severity fulfills at least one of the following three criteria:
1. MDGA ≥ 3 cm (0 - 10 cm Visual Analog Scale \[VAS\]) and MMT-8 score ≤ 142 (out of 150 total possible)
2. Sum of MDGA, PtGA and EMGA VAS scores is ≥ 10 cm (0-10 cm VAS for each)
3. MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of \> 14
* Stable doses of immunosuppressive medications for DM as defined by:
1. Unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent for ≥ 4 weeks before Visit 1
2. Unchanged dose of immunosuppressive medications other than oral corticosteroids for ≥ 8 weeks before Screening
Exclusion Criteria:
* Unstable DM or DM with end-stage organ involvement at Screening or Visit 1
* Significant diseases or conditions other than DM that may influence response to the study drug or safety
* Any of the following values for laboratory tests at Screening:
1. A positive pregnancy test (or at Visit 1)
2. Hemoglobin \< 9 g/dL in males and \< 8 g/dL in females
3. Neutrophils \< 1.0 × 10\^9/L
4. Platelets \< 75 × 10\^9/L
5. Creatinine clearance \< 50 mL/min on screening blood test, per the Modification of Diet in Renal Disease Study or in 24 hour urine creatine clearance measurement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03813160
Study Brief:
Protocol Section:
NCT03813160