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

Sponsored by Bristol-Myers Squibb

About this study

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

Where this study is enrolling (15)

  • Rheumatology Center of San Diego

    San Diego, California

    Call 858-336-2810

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  • South Florida Rheumatology

    Hollywood, Florida

    Call 954-961-3252

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  • Centre for Rheumatology, Immunology and Arthritis

    Fort Lauderdale, Florida

    Call 954-229-0425

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  • One- Rheumatology

    Palm Beach Gardens, Florida

    Call 561-559-1110

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  • LIFE Clinical Trials

    Margate, Florida

    Call 786-674-8868

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Show all 15 locations

  • Willow Rheumatology & Wellness

    Willowbrook, Illinois

    Call 972-432-6708

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  • Arthritis & Rheumatism Associates

    Rockville, Maryland

    Call 301-942-6610

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  • AA MRC

    Grand Blanc, Michigan

    Call 810-667-0067

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  • Sahni Rheumatology & Therapy

    West Long Branch, New Jersey

    Call 732-272-1456

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  • Kings County Hospital Center - Brooklyn

    Brooklyn, New York

    Call 520-834-8259

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  • DJL Clinical Research, PLLC

    Charlotte, North Carolina

    Call 704-247-9179

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  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma

    Call 405-271-7805

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  • Lone Star Arthritis & Rheumatology Associates, P.C.

    Denton, Texas

    Call 480-400-8502

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  • El Paso Medical Research Institute (MedResearch, Inc)

    El Paso, Texas

    Call 915-544-4572

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  • Arthritis Care of Texas - Corpus Christi

    Corpus Christi, Texas

    Call 361-400-7700

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.