An observational study in Systemic Lupus Erythematosus (SLE), sponsored by Bristol-Myers Squibb. Recruiting at 66 sites in 13 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Bristol-Myers Squibb · Observational
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
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 223 is above the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Have active disease at study entry when signing ICF, defined as:
Exclusion Criteria:
Participants with systemic lupus erythematosus (SLE), including Lupus Nephritis, with inadequate response to glucocorticoids and at least 2 immunosuppressants, receiving current standard of care treatment options.
Drug: Current standard of care treatment options
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
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
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lupus Erythematosus, Systemic→
Bristol-Myers Squibb