Actively Recruiting
Prospective, Observational Study in Participants With Active Systemic Lupus Erythematosus (SLE) Including Lupus Nephritis With Inadequate Response to Glucocorticoids and At Least 2 Immunosuppressants
Led by Bristol-Myers Squibb · Updated on 2026-06-02
223
Participants Needed
62
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of current standard treatments for people with active systemic lupus erythematosus (SLE), including lupus nephritis, who have not responded well to glucocorticoids and at least two immunosuppressant therapies. This observational study aims to better understand how these treatments work in real-world settings for patients with active disease and inadequate treatment response. Participants will continue receiving standard care treatments according to their doctors, which may include biologic therapies and other immunosuppressants as guided by current treatment labels. The study observes these participants over time without assigning specific treatments, focusing on those with active lupus and documented inadequate responses to prior therapies. During the study, participants will be monitored regularly for at least 6 months, with some outcomes tracked up to 60 months. Researchers will assess remission rates, kidney responses for those with lupus nephritis, disease activity scores, flare frequency and severity, changes in protein levels and kidney function, and patient-reported fatigue. This long-term monitoring helps understand treatment effects, disease progression, and patient well-being.
CONDITIONS
Brief Title
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have signed an approved informed consent form
- Participants must be 16 years of age or older at the time of consent
- Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE)
- Have an inadequate response to glucocorticoids and at least two immunosuppressant therapies, including a biologic, each used for at least 3 months
- Have active disease at study entry defined by specific disease activity scores (BILAG A or B) and positive autoantibodies
- Participants with lupus nephritis must have had a renal biopsy within 6 months prior to consent showing active Class III or IV LN with specified kidney damage limits
You will not qualify if you...
- Pregnant women
- Participants enrolled in other interventional clinical trials involving investigational therapies
- Participants unwilling or unable to comply with routine clinical follow-up for study data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 months
Participants who undergo routine care are observed while receiving current standard of care treatment options for systemic lupus erythematosus (SLE) with inadequate response to glucocorticoids and immunosuppressants.
Regular visits according to routine clinical follow-up
Trial Site Locations
Total: 62 locations
1
Local Institution - 0062
Mesa, Arizona, United States, 85210
Not Yet Recruiting
2
Local Institution - 0054
La Jolla, California, United States, 92093
Not Yet Recruiting
3
Local Institution - 0001
La Palma, California, United States, 90623-1730
Not Yet Recruiting
4
Local Institution - 0071
Los Angeles, California, United States, 90095
Not Yet Recruiting
5
Rheumatology Center of San Diego
San Diego, California, United States, 92128-2551
Actively Recruiting
6
Local Institution - 0063
Fort Lauderdale, Florida, United States, 33309-1715
Not Yet Recruiting
7
South Florida Rheumatology
Hollywood, Florida, United States, 33021-6052
Actively Recruiting
8
LIFE Clinical Trials
Margate, Florida, United States, 33063
Actively Recruiting
9
One- Rheumatology
Palm Beach Gardens, Florida, United States, 33410
Actively Recruiting
10
Local Institution - 0069
Atlanta, Georgia, United States, 30322-1013
Not Yet Recruiting
11
Local Institution - 0065
Willowbrook, Illinois, United States, 60527
Not Yet Recruiting
12
Local Institution - 0064
Rockville, Maryland, United States, 20850
Not Yet Recruiting
13
Local Institution - 0034
Ann Arbor, Michigan, United States, 48109-5000
Not Yet Recruiting
14
AA MRC
Grand Blanc, Michigan, United States, 48439-2451
Actively Recruiting
15
Local Institution - 0070
Kalispell, Montana, United States, 59901-3129
Not Yet Recruiting
16
Sahni Rheumatology & Therapy
West Long Branch, New Jersey, United States, 07764
Actively Recruiting
17
Kings County Hospital Center - Brooklyn
Brooklyn, New York, United States, 11203
Actively Recruiting
18
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States, 28211
Actively Recruiting
19
Local Institution - 0037
Durham, North Carolina, United States, 27710-1000
Not Yet Recruiting
20
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104-5005
Actively Recruiting
21
Local Institution - 0052
Philadelphia, Pennsylvania, United States, 19140
Not Yet Recruiting
22
Local Institution - 0067
Murfreesboro, Tennessee, United States, 37128
Not Yet Recruiting
23
Arthritis Care of Texas - Corpus Christi
Corpus Christi, Texas, United States, 78415
Actively Recruiting
24
El Paso Medical Research Institute (MedResearch, Inc)
El Paso, Texas, United States, 79902-4821
Actively Recruiting
25
Local Institution - 0051
Van Vleck, Texas, United States, 77482
Not Yet Recruiting
26
Instituto Médico CER
Quilmes, Buenos Aires, Argentina, B1878DVB
Actively Recruiting
27
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
Actively Recruiting
28
Organización Médica de Investigación (OMI)
Buenos Aires, Argentina, C1015ABO
Actively Recruiting
29
Instituto De Reumatologia - IR Medical Center - Hospital de Dia
Mendoza, Argentina, M5500CPH
Actively Recruiting
30
Local Institution - 0007
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Not Yet Recruiting
31
Local Institution - 0042
São Paulo, Brazil, 05403-000
Not Yet Recruiting
32
Centre hospitalier de l'Université Laval
Calgary, Alberta, Canada, T2T 5C7
Actively Recruiting
33
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Actively Recruiting
34
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
35
Local Institution - 0038
Sherbrooke, Quebec, Canada, J1G 2E8
Not Yet Recruiting
36
CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
Actively Recruiting
37
Hôpital Saint-Antoine
Paris, Île-de-France Region, France, 75012
Actively Recruiting
38
Local Institution - 0041
Kiel, Schleswig-Holstein, Germany, 24105
Not Yet Recruiting
39
Local Institution - 0043
Mainz, Germany, 55131
Not Yet Recruiting
40
Meir Medical Center
Kfar Saba, M, Israel, 4428164
Actively Recruiting
41
Sheba Medical Center
Ramat Gan, TA, Israel, 5262000
Actively Recruiting
42
Rambam Medical Center
Haifa, Israel, 31096
Actively Recruiting
43
Carmel Medical Center
Haifa, Israel, 34362
Actively Recruiting
44
Rabin Medical Center - Hasharon Hospital
Petah Tikva, Israel, 4941492
Actively Recruiting
45
Local Institution - 0025
Tel Aviv, Israel, 6423906
Not Yet Recruiting
46
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Ferrara, RE, Italy, 44124
Actively Recruiting
47
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, TO, Italy, 10128
Actively Recruiting
48
ASST degli Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
49
Local Institution - 0049
Kitakyushu-shi, Fukuoka, Japan, 807-8555
Not Yet Recruiting
50
Local Institution - 0053
Sendai, Miyagi, Japan, 980-8574
Not Yet Recruiting
51
Local Institution - 0055
Wakayama, Japan, 641-8510
Not Yet Recruiting
52
Local Institution - 0046
San Juan, PR, Puerto Rico, 00917-3104
Not Yet Recruiting
53
Hospital de Merida
Mérida, Badajoz, Spain, 6800
Actively Recruiting
54
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
55
Local Institution - 0072
Lund, Skåne County, Sweden, SE-221 85
Not Yet Recruiting
56
Local Institution - 0073
Solna, Stockholm County, Sweden, 171 64
Not Yet Recruiting
57
Local Institution - 0074
Örebro, Sweden, 701 85
Not Yet Recruiting
58
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, OXF, United Kingdom, OX3 7LE
Actively Recruiting
59
Royal National Hospital for Rheumatic Diseases-Bath
Bath, SOM, United Kingdom, BA1 3NG
Actively Recruiting
60
The Royal Wolverhampton NHS Trust - New Cross Hospital
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Actively Recruiting
61
Local Institution - 0059
London, United Kingdom, NW3 2QG
Not Yet Recruiting
62
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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