BENCHMARK-SLE
Research type
Research Study
Full 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 (Benchmark-SLE)
IRAS ID
364412
Contact name
Massimiliano Cristofanilli
Contact email
Sponsor organisation
Bristol-Mayers Squibb Company
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This observational study is designed to learn more about how current standard of care treatment options are working to treat patients with Systemic Lupus Erythematosus (SLE) and lupus nephritis (LN). SLE is a disease where the body’s immune system mistakenly attacks its own healthy tissues and organs.
The study population will include individuals diagnosed with SLE, who have an 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.
The study will be conducted globally and will enrol approximately 223 patients. Patients can expect to be in this study for about 5 years (60 months).
At each visit, participants will have health evaluation and medical history, physical examination, efficacy assessments and questionnaires (patient reported outcomes). As part of standard of care, patients may have blood samples, urine samples and a renal biopsy.
The study is sponsored by Bristol-Myers Squibb Company.REC name
London - Chelsea Research Ethics Committee
REC reference
26/PR/0079
Date of REC Opinion
27 Feb 2026
REC opinion
Further Information Favourable Opinion