Systemic Lupus Erythematosus (SLE)
Conditions
Keywords
Systemic lupus erythematosus (SLE)
Brief 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
Interventions
DRUGCurrent standard of care treatment options
According to the product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of of participants achieving Definition of Remission in Systemic Lupus Erythematosus (DORIS) at 6 months along with the 95% CI. | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission | At 12, 24, 36, 48, and 60 months | — |
| Complete renal response (CRR) for participants with baseline lupus nephritis (LN) | 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 | At 12, 24, 36, 48, and 60 months | — |
| Incidence and severity of flares, as assessed by Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) index | Up to 60 months | — |
| SLE Responder Index 4 (SRI-4) for participants with baseline Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥ 6 | 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 | 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 | At 12, 24, 36, 48, and 60 months | — |
| Number of participants that maintain remission status as assessed by DORIS, LLDAS, and SRI-4 | At 6, 12, 24, 36, 48, and 60 months | Definition of Remission in Systemic Lupus Erythematosus (DORIS), Lupus-Low Disease Activity State (LLDAS) and SLE Responder Index 4 (SRI-4) |
| Duration of treatment response | Up to 60 months | — |
| Time to treatment response | Up to 60 months | — |
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) patient reported outcome (PRO) from baseline | Baseline, and at 6, 12, 24, 36, 48, and 60 months | — |
Countries
Argentina, Brazil, Canada, France, Germany, Israel, Italy, Japan, Puerto Rico, Spain, Sweden, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed