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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT01534403
Eligibility Criteria:
Inclusion Criteria:
* Subject has completed the double-blind study SL0026 \[NCT01449071\] or terminated prematurely at Week 8 or later in SL0026 \[NCT01449071\] due to lack of efficacy
* Women of childbearing potential must agree to use an acceptable method of birth control/Written Informed Consent
Exclusion Criteria:
* Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A
* Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
* Substance abuse or dependence
* Significant hematologic abnormalities
* History of malignant cancer
* Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01534403
Study Brief:
Protocol Section:
NCT01534403