Treatment outcomes for people with active SLE not helped by steroids and multiple immunosuppressants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-site observational cohort that collects clinical and safety data on standard-of-care treatments in people with active systemic lupus erythematosus, including lupus nephritis, who have had an inadequate response to glucocorticoids and at least two immunosuppressants. Eligible participants are 16 years and older, must meet the EULAR/ACR 2019 classification criteria, and must have shown inadequate or unsustained response after at least three months of appropriate dosing for each prior therapy, including one biologic. Investigators will record treatment regimens, disease activity measures, organ-specific outcomes, laboratory results, and adverse events during routine visits without assigning experimental therapies. Collected data will be used to characterize real-world effectiveness and safety across existing treatment options for this hard-to-treat SLE population.

Why it matters

Who can join: the full rules

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

Where it's running

• Rheumatology Center of San Diego
  San Diego, California, United States Recruiting
• Centre for Rheumatology, Immunology and Arthritis
  Fort Lauderdale, Florida, United States Recruiting
• South Florida Rheumatology
  Hollywood, Florida, United States Recruiting
• LIFE Clinical Trials
  Margate, Florida, United States Recruiting
• One- Rheumatology
  Palm Beach Gardens, Florida, United States Recruiting
• Willow Rheumatology & Wellness
  Willowbrook, Illinois, United States Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.