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

Recruiting · NCT07175285 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bristol-Myers Squibb

View the official record on ClinicalTrials.gov →

Lupus

Interventions studied

Current standard of care treatment options

What this trial is about

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

Who can take part

Age range

16 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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 is running

60 locations listed across 14 US states.

Local Institution - 0054 - La Jolla, California, United States
Local Institution - 0001 - La Palma, California, United States
Local Institution - 0071 - Los Angeles, California, United States
Rheumatology Center of San Diego - San Diego, California, United States
Centre for Rheumatology, Immunology and Arthritis - Fort Lauderdale, Florida, United States
South Florida Rheumatology - Hollywood, Florida, United States
LIFE Clinical Trials - Margate, Florida, United States
One- Rheumatology - Palm Beach Gardens, Florida, United States
Local Institution - 0069 - Atlanta, Georgia, United States
Willow Rheumatology & Wellness - Willowbrook, Illinois, United States
Arthritis & Rheumatism Associates - Rockville, Maryland, United States
Local Institution - 0034 - Ann Arbor, Michigan, United States
AA MRC - Grand Blanc, Michigan, United States
Local Institution - 0070 - Kalispell, Montana, United States
Sahni Rheumatology & Therapy - West Long Branch, New Jersey, United States
Kings County Hospital Center - Brooklyn - Brooklyn, New York, United States
DJL Clinical Research, PLLC - Charlotte, North Carolina, United States
Local Institution - 0037 - Durham, North Carolina, United States
Oklahoma Medical Research Foundation - Oklahoma City, Oklahoma, United States
Local Institution - 0075 - Philadelphia, Pennsylvania, United States
Local Institution - 0052 - Philadelphia, Pennsylvania, United States
Murfreesboro Medical Clinic - Murfreesboro, Tennessee, United States
Arthritis Care of Texas - Corpus Christi - Corpus Christi, Texas, United States
Lone Star Arthritis & Rheumatology Associates, P.C. - Denton, Texas, United States
El Paso Medical Research Institute (MedResearch, Inc) - El Paso, Texas, United States
Local Institution - 0051 - Van Vleck, Texas, United States
Hospital Clínic de Barcelona - Barcelona, Spain
CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin - Bordeaux, France
ASST degli Spedali Civili di Brescia - Brescia, Italy
Organización Médica de Investigación (OMI) - Buenos Aires, Argentina
Rambam Medical Center - Haifa, Israel
Carmel Medical Center - Haifa, Israel
Hospital of the University of Occupational and Environmental Health, Japan - Kitakyushu-Shi, Japan
The Royal Free London NHS Foundation Trust - The Royal Free Hospital - London, United Kingdom
King's College Hospital NHS Foundation Trust - London, United Kingdom
Local Institution - 0043 - Mainz, Germany
Instituto De Reumatologia - IR Medical Center - Hospital de Dia - Mendoza, Argentina
Rabin Medical Center - Hasharon Hospital - Petah Tikva, Israel
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre - Strasbourg, France
Local Institution - 0042 - São Paulo, Brazil
Local Institution - 0025 - Tel Aviv, Israel
Wakayama Medical University Hospital - Wakayama, Japan
Local Institution - 0074 - Örebro, Sweden
Centre hospitalier de l'Université Laval - Calgary, Alberta, Canada
Hospital de Merida - Mérida, Badajoz, Spain
Instituto Médico CER - Quilmes, Buenos Aires, Argentina
Meir Medical Center - Kfar Saba, M, Israel
Tohoku University Hospital - Sendai, Miyagi, Japan
Oxford University Hospitals NHS Trust - Churchill Hospital - Oxford, OXF, United Kingdom
St. Joseph's Hospital - London, Ontario, Canada
The Ottawa Hospital - General Campus - Ottawa, Ontario, Canada
Local Institution - 0046 - San Juan, PR, Puerto Rico
Local Institution - 0038 - Sherbrooke, Quebec, Canada
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ferrara, RE, Italy
Hospital de Clinicas de Porto Alegre - Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0007 - Porto Alegre, Rio Grande do Sul, Brazil
Royal National Hospital for Rheumatic Diseases-Bath - Bath, SOM, United Kingdom
Local Institution - 0041 - Kiel, Schleswig-Holstein, Germany
Local Institution - 0072 - Lund, Skåne County, Sweden
Local Institution - 0073 - Solna, Stockholm County, Sweden

Showing 60 of 66 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →