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:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT02612857
Eligibility Criteria:
Inclusion Criteria:
* Has definite or probable DM based on the criteria of Bohan and Peter
* Has a Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)-Activity score ≥15
* Patients with muscle weakness are eligible; however having muscle weakness is not mandatory.
* Study participants must have a diagnostic evaluation for cancer if the diagnosis of DM was within 2 years prior to the Screening Visit
Exclusion Criteria:
* Has ongoing severe dysphagia (e.g., requires a feeding tube) for the 3 months prior to Screening
* Has known hypersensitivity to any oligodeoxynucleotide
* Has a history of drug or alcohol abuse within one year of screening, or evidence of drug abuse by urine drug screening
* Has body weight \>140 kg
* Has a diagnosis of Juvenile DM, IBM, drug-induced toxic myopathy, metabolic myopathy, dystrophy, cancer-associated DM, or connective tissue disease-associated DM (e.g., overlap syndrome)
* Has received one or more of following prohibited treatments within the interval noted prior to Screening (Visit 1):
1. Rituximab within 24 weeks (Note: patients who received rituximab are only eligible for inclusion if B-cell counts are confirmed to be within normal limits)
2. Intravenous corticosteroids within 12 weeks
3. Antimalarials (e.g., hydroxychloroquine) within 36 weeks
4. Topical corticosteroids (excluding scalp) within 2 weeks
* Has evidence of or has required treatment for cancer (except for treated, non-invasive carcinoma of the skin or cured cervical carcinoma-in-situ) within 5 years
* Has interstitial lung disease requiring the use of supplemental oxygen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02612857
Study Brief:
Protocol Section:
NCT02612857