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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT05845593
Eligibility Criteria:
Inclusion Criteria:
1. Male or female aged at least 18 years old.
2. Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation
3. Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician
4. On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing
Exclusion Criteria:
1. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patient at undue risk
2. Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month
3. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline
4. Pregnant or lactating.
5. Recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer
6. Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05845593
Study Brief:
Protocol Section:
NCT05845593