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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT02514967
Eligibility Criteria:
Inclusion Criteria:
* Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology
* Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy
* Positive for anti-double stranded DNA (anti-dsDNA) and low complement
* Subjects with stable nephritis may be enrolled
* 18 years of age or older
Exclusion Criteria:
* Severe active central nervous system lupus
* Malignancy within past 5 years
* Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
* Comorbidities that would interfere with evaluations of study drug effect
* Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
* History of active tuberculosis or a history of tuberculosis infection
* Pregnant or nursing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02514967
Study Brief:
Protocol Section:
NCT02514967