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Observational Study for Systemic Lupus Erythematosus

This is an observational study for people with active systemic lupus erythematosus (SLE), including lupus nephritis (lupus affecting the kidneys). You might be eligible if your SLE hasn't responded well to steroid medications (glucocorticoids) and at least two other immunosuppressant drugs. The study aims to understand how well current standard of care treatments work and their safety in this group of patients. Researchers will measure how many participants achieve "remission" (a period when disease symptoms are reduced or absent) using a specific definition called DORIS, at 6 months. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information about 223 participants receiving their usual care. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will assess participants for remission at 6 months.

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NCT07175285

A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants

Recruiting
Not specifiedAges 16+Observational
Bristol-Myers Squibb
~223 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Current standard of care treatment options

At a glance

Recruiting sites
43 of 65 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of of participants achieving Definition of Remission in Systemic Lupus Erythematosus (DORIS) at 6 months along with the 95% CI.
Measured over 6 months

Conditions

Systemic Lupus Erythematosus (SLE)

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Where it's being run

65 sites across 46 states
California4
Florida4
Israel4
Texas3
Michigan2
North Carolina2
Argentina2
Rio Grande do Sul2

Study leadership

  • Bristol Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Have active disease at study entry when signing ICF, defined as:
≥ 1 British Isles Lupus Assessment Group Index (BILAG) A OR ≥ 1 BILAG B with history of SLE manifestations that would qualify for a BILAG A within the last 24 months, AND
Positive autoantibodies (at least one) to confirm diagnosis of SLE: Antinuclear antibody ≥1:160, anti-dsDNA, anti-Sm, anti-Ro (SSA), anti-La (SSB), or low complement proteins (C3 or C4)
Participants with lupus nephritis (LN) meeting the study eligibility criteria must have had a renal biopsy per standard of care within 6 months (± 30 days) prior to signing the ICF, indicating the presence of active Class III or IV LN (alone or in combination with Class V) according to the 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS), with \< 60% interstitial fibrosis and tubular atrophy \< 60% global glomerulosclerosis

Exclusion

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

What this trial measures

  • Number of of participants achieving Definition of Remission in Systemic Lupus Erythematosus (DORIS) at 6 months along with the 95% CI.6 months