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Observes standard treatments in lupus patients not helped by current medicines

Follows adults with active lupus, including kidney involvement, on standard treatments.

Key facts

Who runs it
Bristol-Myers Squibb
Where
San Juan, Puerto RicoSee the siteAlso in 12 other countries, 69 sites
Trial code
Registry title
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
Status
Recruiting
People taking part
223 people, planned
Started
8 Oct 2025
Expected to end
5 Oct 2032
Type of study
Observational
Treatments tested
  • Current standard of care treatment options
Record updated
2 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 16 or older with active systemic lupus erythematosus (SLE), including lupus nephritis. Their lupus did not respond well enough to glucocorticoids and at least 2 immunosuppressants.

Age
16 years or older
Sex
All sexes can join.
Disease stage
Active SLE meeting the EULAR/ACR 2019 criteria, with at least 1 BILAG A, or at least 1 BILAG B with a history that would qualify for a BILAG A within the last 24 months. Lupus nephritis must be active Class III or IV (alone or with Class V) on a kidney biopsy taken within 6 months (± 30 days) before consent, with less than 60% interstitial fibrosis and tubular atrophy and less than 60% global glomerulosclerosis.
Earlier treatment
Inadequate response to glucocorticoids and at least 2 immunosuppressant therapies, one of them a biologic, each used for at least 3 months. Intolerance or a contraindication can count as inadequate response if documented and confirmed by the Adjudication Committee. Prior hydroxychloroquine or other anti-malarial treatment does not matter.
Biomarker or test result
At least one positive autoantibody: antinuclear antibody 1:160 or higher, anti-dsDNA, anti-Sm, anti-Ro (SSA) or anti-La (SSB), or low complement proteins (C3 or C4).

Main reasons for not taking part

  • Pregnant women
  • People taking part in another clinical trial, including trials of investigational therapies
  • People unwilling or unable to attend the routine follow-up visits needed for the study data

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Participants enrolled in concurrent interventional clinical trials involving investigational therapies or any other clinical trial
  • Pregnant women
  • Participant is unwilling or unable to comply with routine clinical follow-up necessary for collection of study data

Where in Puerto Rico

Also in 12 other countries, 69 sites

  • San Juan, PRHospital not named in the registryContact: Site 0046Not yet recruiting

About the trial

What the trial wants to find out

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

The group in the trial

  • Group 1

    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.

    Treatment: Current standard of care treatment options

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prospective, Observational Study in Participants With Active Systemic Lupus Erythematosus (SLE) (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and At Least 2 Immunosuppressants
Plain-language title
Observes standard treatments in lupus patients not helped by current medicinesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 November 2026