Current Treatments for Active Systemic Lupus Erythematosus
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
Recruiting
Observational Study
Systemic Lupus Erythematosus (SLE)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
16 and older
Sex
Any
Study type
Observational
Participants needed
223 (estimated)
Sponsor
Bristol-Myers Squibb · Industry
Who this trial is looking for
This trial is looking for people with active systemic lupus erythematosus who have not responded well to previous treatments. Participants will need to meet specific health criteria and may undergo assessments to evaluate their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 16 years old.
I have been diagnosed with systemic lupus erythematosus.
I have not responded well to glucocorticoids and at least 2 immunosuppressants.
I have active disease at the time I enter the study.
I have positive autoantibodies confirming my SLE diagnosis.
You may not be able to join if
I am pregnant.
I am currently in another clinical trial.
I am unable to attend regular check-ups required for the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 …
Inclusion Criteria:
* 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 Criteria:
* 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
Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
First line of the email MUST contain NCT # and Site #.
CONTACT
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