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 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT01972568
Eligibility Criteria:
Inclusion Criteria:
* Eligible male and female subjects, aged 18 years or older
* Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to \[\>=\] 6 at screening visit
* At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed \>= 6 months prior to the screening visit)
* Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* Subjects have demyelinating disorder
* Severe central nervous system SLE
* Use of cyclophosphamide within 3 months of the screening visit
* Urine protein:creatinine ratio (UPCr) \>= 2 milligram per milligram (mg/mg) per day
* Other protocol defined exclusion criteria could apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01972568
Study Brief:
Protocol Section:
NCT01972568