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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT05747651
Eligibility Criteria:
Inclusion Criteria:
* 1\. Age at the time of inclusion ≥ 18 years.
* 2\. Able to consent and agree to participate in the study.
* 3\. Diagnosis of SLE according to the EULAR/ACR criteria.
* 4\. Patients should have at least one of the following: i. active arthritis, attributed to SLE (BILAG A or B in the musculoskeletal domain).
ii. active skin disease, attributed to SLE (BILAG A or B in the mucocutaneous domain).
iii. active biopsy-proven lupus nephritis (LN; ISN/RPS class III, IV or V), with or without extrarenal organ involvement.
iv. active CNS involvement as a main manifestation (with or without other organ involvement) along with initiation of new treatment for CNS involvement (BILAG A or B in the neuropsychiatric domain).
* 5\. Stable standard therapy for at least 30 days, including hydroxychloroquine (HCQ) or chloroquine treatment, unless contraindicated or documented intolerance.
Exclusion Criteria:
* 1\. Serological activity only without signs of clinically active disease.
* 2\. Pregnancy and/or breastfeeding.
* 3\. Unable/unaware to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05747651
Study Brief:
Protocol Section:
NCT05747651