The purpose of this study is to characterize the efficacy and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response to glucocorticoids and at least two immunosuppressants
Participants must have signed and dated an Institutional Review Board/ Independent Ethics Committee (IRB/IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines
Participants must be ≥16 years of age at the time of signing the ICF
Meet the European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2019 classification criteria for systemic lupus erythematosus (SLE)
Have an inadequate response to glucocorticoids and ≥ 2 immunosuppressant therapies, one of which is a biologic therapy consistent with treatment guidelines, used for at least 3 months each. Eligibility is regardless of prior hydroxychloroquine or any anti-malarial treatment. Inadequate response is defined as a lack of response, insufficient response, or lack of sustained response after at least 3-month treatment with appropriate doses of a standard of care agent. Intolerance or contraindication may be considered as inadequate response provided it is documented and confirmed acceptable by the Adjudication Committee
Pregnant women
Participants enrolled in concurrent interventional clinical trials involving investigational therapies or any other clinical trial
Participant is unwilling or unable to comply with routine clinical follow-up necessary for collection of study data
The study population will include individuals diagnosed with systemic lupus erythematosus (SLE) with inadequate response (a lack of response, insufficient response, or lack of sustained response after at least 3-month treatment with appropriate doses of a standard of care therapy) to glucocorticoids and at least two immunosuppressants according to routine clinical practice
Cohort
Prospective
Current standard of care treatment options
DrugAccording to the product label
Number of of participants achieving Definition of Remission in Systemic Lupus Erythematosus (DORIS) at 6 months along with the 95% CI.
Number of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission
Complete renal response (CRR) for participants with baseline lupus nephritis (LN)
Lupus-Low Disease Activity State (LLDAS) for participants with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥ 6
Incidence and severity of flares, as assessed by Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) index
Click on the lead sponsor to view all of their trials.
