Systemic Lupus Erythematosus (SLE)BENCHMARK-SLENCT07175285
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
An observational study of Systemic Lupus Erythematosus (SLE), run by Bristol-Myers Squibb at 66 sites in 13 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- How many people
- 223 participants
- Where
- 66 sitesin 13 countries
- Study dates
- 8 Oct 2025to 5 Oct 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include individuals diagnosed with systemic lupus erythematosus (SLE) with inadequate response (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 therapy) to glucocorticoids and at least two immunosuppressants according to routine clinical practice
Who may be able to join
- 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 join
- 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
Trial locations and contacts
66 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
66 sites in 13 countries
United States26 sites, 25 recruiting
- Not yet recruiting
Local Institution - 0034
Ann Arbor, Michigan, 48109-5000
Site 0034
- Not yet recruiting
Local Institution - 0069
Atlanta, Georgia, 30322-1013
Site 0069
- Recruiting
Kings County Hospital Center - Brooklyn
Brooklyn, New York, 11203
Alexander Feoktistov, Site 0039, 520-834-8259
- Recruiting
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28211
Charles Withers, Site 0026, 704-247-9179
- Recruiting
Arthritis Care of Texas - Corpus Christi
Corpus Christi, Texas, 78415
Eric Chiang, Site 0066, 361-400-7700
- Recruiting
Lone Star Arthritis & Rheumatology Associates, P.C.
Denton, Texas, 76205
Michelle Luciano, Site 0062, 480-400-8502
- Withdrawn
Local Institution - 0037
Durham, North Carolina, 27710-1000
- Recruiting
El Paso Medical Research Institute (MedResearch, Inc)
El Paso, Texas, 79902-4821
German Hernandez, Site 0027, 915-544-4572
- Recruiting
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33309-1715
Yvonne Sherrer, Site 0063, 954-229-0425
- Recruiting
AA MRC
Grand Blanc, Michigan, 48439-2451
Ali Karrar, Site 0030, 810-667-0067
- Recruiting
South Florida Rheumatology
Hollywood, Florida, 33021-6052
Gizem Gokalp, Site 0061, 954-961-3252
- Not yet recruiting
Local Institution - 0070
Kalispell, Montana, 59901-3129
Site 0070
- Not yet recruiting
Local Institution - 0054
La Jolla, California, 92093
Site 0054
- Not yet recruiting
Local Institution - 0001
La Palma, California, 90623-1730
Site 0001
- Not yet recruiting
Local Institution - 0071
Los Angeles, California, 90095
Site 0071
- Recruiting
LIFE Clinical Trials
Margate, Florida, 33063
Jigar Shah, Site 0006, 786-674-8868
- Recruiting
Murfreesboro Medical Clinic
Murfreesboro, Tennessee, 37128
Marcus Owen, Site 0067
- Recruiting
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104-5005
Cristina Arriens, Site 0019, 405-271-7805
- Recruiting
One- Rheumatology
Palm Beach Gardens, Florida, 33410
Clifford Stermer, Site 0068, 561-559-1110
- Not yet recruiting
Local Institution - 0075
Philadelphia, Pennsylvania, 19104
Site 0075
- Not yet recruiting
Local Institution - 0052
Philadelphia, Pennsylvania, 19140
Site 0052
- Recruiting
Arthritis & Rheumatism Associates
Rockville, Maryland, 20850
Evan Siegel, Site 0064, 301-942-6610
- Recruiting
Rheumatology Center of San Diego
San Diego, California, 92128-2551
Tania Rivera, Site 0035, 858-336-2810
- Not yet recruiting
Local Institution - 0051
Van Vleck, Texas, 77482
Site 0051
- Recruiting
Sahni Rheumatology & Therapy
West Long Branch, New Jersey, 07764
KIREN SAHNI, Site 0060, 732-272-1456
- Recruiting
Willow Rheumatology & Wellness
Willowbrook, Illinois, 60527
Angela Crowley, Site 0065, 972-432-6708
Israel6 sites, 6 recruiting
- Recruiting
Rambam Medical Center
Haifa, 31096
Yolanda Braun-Moscovici, Site 0011, +97248542013
- Recruiting
Carmel Medical Center
Haifa, 34362
Devy Zisman, Site 0036, +97248260213
- Recruiting
Meir Medical Center
Kfar Saba, M, 4428164
Shaye Kivity, Site 0012
- Recruiting
Rabin Medical Center - Hasharon Hospital
Petah Tikva, 4941492
Ari Polachek, Site 0022, 972039377077
- Recruiting
Sheba Medical Center
Ramat Gan, TA, 5262000
Merav Lidar, Site 0031, 97235302156
- Not yet recruiting
Local Institution - 0025
Tel Aviv, 6423906
Site 0025
United Kingdom5 sites, 5 recruiting
- Recruiting
Royal National Hospital for Rheumatic Diseases-Bath
Bath, SOM, BA1 3NG
Sarah Skeoch, Site 0058
- Recruiting
The Royal Free London NHS Foundation Trust - The Royal Free Hospital
London, NW3 2QG
Shahir Hamdulay, Site 0059, +2077940500
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Jonathan Dick, Site 0057
- Recruiting
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, OXF, OX3 7LE
Anthony Psarras, Site 0056, +441865270000
- Recruiting
The Royal Wolverhampton NHS Trust - New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP
Thomas Sheeran, Site 0045, 441213532444
Argentina4 sites, 4 recruiting
- Recruiting
Organización Médica de Investigación (OMI)
Buenos Aires, C1015ABO
Joaquin Martinez Serventi, Site 0050
- Recruiting
Instituto De Reumatologia - IR Medical Center - Hospital de Dia
Mendoza, M5500CPH
Marcos Alfredo Borgia, Site 0008, +54155440980
- Recruiting
Instituto Médico CER
Quilmes, Buenos Aires, B1878DVB
Alejandro Benitez, Site 0009, 541152633113
- Recruiting
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, T4000AXL
Walter Spindler, Site 0029, +54-9-381-5537820
Canada4 sites, 4 recruiting
- Recruiting
Centre hospitalier de l'Université Laval
Calgary, Alberta, T2T 5C7
Paul Fortin, Site 0018, 4166035753
- Recruiting
St. Joseph's Hospital
London, Ontario, N6A 4V2
Janet Pope, Site 0020, 519 646 6332
- Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Catherine Ivory, Site 0021
- Not yet recruiting
Local Institution - 0038
Sherbrooke, Quebec, J1G 2E8
Site 0038
Japan4 sites, 4 recruiting
- Recruiting
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-Shi, 807-8556
Satoshi Kubo, Site 0049, 093-603-1611
- Recruiting
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Hiroshi Fujii, Site 0053, 81227177000
- Recruiting
Toyama University
Toyama, Toyama, 930-0887
Masaru Kato, Site 0010, +81-76-434-7287
- Recruiting
Wakayama Medical University Hospital
Wakayama, 641-8510
Takao Fujii, Site 0055, +81-73-441-0875
Brazil3 sites, 3 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Odirlei Monticielo, Site 0005, 51996526170
- Not yet recruiting
Local Institution - 0007
Porto Alegre, Rio Grande do Sul, 90610-000
Site 0007
- Not yet recruiting
Local Institution - 0042
São Paulo, 05403-000
Site 0042
France3 sites, 3 recruiting
- Recruiting
CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076
Christophe RICHEZ, Site 0023, 0556794919
- Recruiting
Hôpital Saint-Antoine
Paris, Île-de-France Region, 75012
Amir Adedjouma, Site 0044
- Recruiting
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098
Marc SCHERLINGER, Site 0024, 0388127954
Italy3 sites, 3 recruiting
- Recruiting
ASST degli Spedali Civili di Brescia
Brescia, 25123
Micaela Fredi, Site 0015, +390303995487
- Recruiting
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Ferrara, RE, 44124
Alessandra Bortoluzzi, Site 0040, +390532239651
- Recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, TO, 10128
Mariele Gatto, Site 0014, +390498275111
Sweden3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0072
Lund, Skåne County, SE-221 85
Site 0072
- Not yet recruiting
Local Institution - 0074
Örebro, 701 85
Site 0074
- Not yet recruiting
Local Institution - 0073
Solna, Stockholm County, 171 64
Site 0073
Germany2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0041
Kiel, Schleswig-Holstein, 24105
Site 0041
- Not yet recruiting
Local Institution - 0043
Mainz, 55131
Site 0043
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Ignasi Rodriguez Pinto, Site 0048, +34607573229
- Recruiting
Hospital de Merida
Mérida, Badajoz, 6800
Raul Veroz Gonzalez, Site 0047, +34924381000
Puerto Rico1 site, 1 recruiting
- Not yet recruiting
Local Institution - 0046
San Juan, PR, 00917-3104
Site 0046
About this study
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
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
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- Current standard of care treatment options
- Keywords
- Systemic lupus erythematosus (SLE)
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current standard of care treatment optionsDrug
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Current standard of care treatment options |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of of participants achieving Definition of Remission in Systemic Lupus Erythematosus (DORIS) at 6 months along with the 95% CI.
Measured: 6 months
Secondary outcomes (11)
Number of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission
Measured: At 12, 24, 36, 48, and 60 months
Complete renal response (CRR) for participants with baseline lupus nephritis (LN)
Measured: At 6, 12, 24, 36, 48, and 60 months
Lupus-Low Disease Activity State (LLDAS) for participants with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥ 6
Measured: At 12, 24, 36, 48, and 60 months
Incidence and severity of flares, as assessed by Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) index
Measured: Up to 60 months
SLE Responder Index 4 (SRI-4) for participants with baseline Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥ 6
Measured: At 6, 12, 24, 36, 48, and 60 months
Change from baseline in proteinuria and estimated glomerular filtration rate (eGFR) - of those with high proteinuria and low eGFR
Measured: At 6, 12, 24, 36, 48, and 60 months
Change in 2012 Systemic Lupus Collaborating Clinics Criteria for SLE (SLICC) / America College of Rheumatology (ACR) Damage Index (SDI) from baseline
Measured: At 12, 24, 36, 48, and 60 months
Number of participants that maintain remission status as assessed by DORIS, LLDAS, and SRI-4
Definition of Remission in Systemic Lupus Erythematosus (DORIS), Lupus-Low Disease Activity State (LLDAS) and SLE Responder Index 4 (SRI-4)
Measured: At 6, 12, 24, 36, 48, and 60 months
Duration of treatment response
Measured: Up to 60 months
Time to treatment response
Measured: Up to 60 months
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) patient reported outcome (PRO) from baseline
Measured: Baseline, and at 6, 12, 24, 36, 48, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start8 Oct 2025
- Primary completion24 Mar 2028 (estimated)
- Study completion5 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 223 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175285
- Sponsor's protocol ID
- CA061-1025
- Acronym
- BENCHMARK-SLE
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No