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
Study Type
OBSERVATIONAL
Enrollment
223
According 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.
Time frame: 6 months
Number of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission
Time frame: At 12, 24, 36, 48, and 60 months
Complete renal response (CRR) for participants with baseline lupus nephritis (LN)
Time frame: At 6, 12, 24, 36, 48, and 60 months
Lupus-Low Disease Activity State (LLDAS) for participants with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥ 6
Time frame: At 12, 24, 36, 48, and 60 months
Incidence and severity of flares, as assessed by Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) index
Time frame: Up to 60 months
SLE Responder Index 4 (SRI-4) for participants with baseline Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥ 6
Time frame: At 6, 12, 24, 36, 48, and 60 months
Change from baseline in proteinuria and estimated glomerular filtration rate (eGFR) - of those with high proteinuria and low eGFR
Time frame: At 6, 12, 24, 36, 48, and 60 months
Change in 2012 Systemic Lupus Collaborating Clinics Criteria for SLE (SLICC) / America College of Rheumatology (ACR) Damage Index (SDI) from baseline
Time frame: At 12, 24, 36, 48, and 60 months
Number of participants that maintain remission status as assessed by DORIS, LLDAS, and SRI-4
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Local Institution - 0054
La Jolla, California, United States
NOT_YET_RECRUITINGLocal Institution - 0001
La Palma, California, United States
NOT_YET_RECRUITINGLocal Institution - 0071
Los Angeles, California, United States
NOT_YET_RECRUITINGRheumatology Center of San Diego
San Diego, California, United States
RECRUITINGCentre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States
RECRUITINGSouth Florida Rheumatology
Hollywood, Florida, United States
RECRUITINGLIFE Clinical Trials
Margate, Florida, United States
RECRUITINGOne- Rheumatology
Palm Beach Gardens, Florida, United States
RECRUITINGLocal Institution - 0069
Atlanta, Georgia, United States
NOT_YET_RECRUITINGWillow Rheumatology & Wellness
Willowbrook, Illinois, United States
RECRUITING...and 56 more locations
Definition of Remission in Systemic Lupus Erythematosus (DORIS), Lupus-Low Disease Activity State (LLDAS) and SLE Responder Index 4 (SRI-4)
Time frame: At 6, 12, 24, 36, 48, and 60 months
Duration of treatment response
Time frame: Up to 60 months
Time to treatment response
Time frame: Up to 60 months
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) patient reported outcome (PRO) from baseline
Time frame: Baseline, and at 6, 12, 24, 36, 48, and 60 months