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

Purpose

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

Condition

  • Systemic Lupus Erythematosus (SLE)

Eligibility

Eligible Ages
Over 16 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Current standard of care treatment options
    According to the product label

Recruiting Locations

Rheumatology Center of San Diego
San Diego, California 92128-2551
Contact:
Tania Rivera, Site 0035
858-336-2810

LIFE Clinical Trials
Margate, Florida 33063
Contact:
Jigar Shah, Site 0006
786-674-8868

AA MRC
Grand Blanc, Michigan 48439-2451
Contact:
Ali Karrar, Site 0030
810-667-0067

Kings County Hospital Center - Brooklyn
Brooklyn, New York 11203
Contact:
Alexander Feoktistov, Site 0039
520-834-8259

DJL Clinical Research, PLLC
Charlotte, North Carolina 28211
Contact:
Charles Withers, Site 0026
704-247-9179

Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104-5005
Contact:
Cristina Arriens, Site 0019
405-271-7805

El Paso Medical Research Institute (MedResearch, Inc)
El Paso, Texas 79902-4821
Contact:
German Hernandez, Site 0027
915-544-4572

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com