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

Официальное название

Prospective, Observational Study in Participants With Active Systemic Lupus Erythematosus (SLE) (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and At Least 2 Immunosuppressants

Обзор

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

Вмешательства

• Препарат Current standard of care treatment options
  According to the product label

Первичные конечные точки

• Number of of participants achieving Definition of Remission in Systemic Lupus Erythematosus (DORIS) at 6 months along with the 95% CI. [Срок оценки: 6 months]

Вторичные конечные точки (11)

• Number of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission [Срок оценки: At 12, 24, 36, 48, and 60 months]
• Complete renal response (CRR) for participants with baseline lupus nephritis (LN) [Срок оценки: 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 [Срок оценки: At 12, 24, 36, 48, and 60 months]
• Incidence and severity of flares, as assessed by Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) index [Срок оценки: Up to 60 months]
• SLE Responder Index 4 (SRI-4) for participants with baseline Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥ 6 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At 12, 24, 36, 48, and 60 months]
• Number of participants that maintain remission status as assessed by DORIS, LLDAS, and SRI-4 [Срок оценки: At 6, 12, 24, 36, 48, and 60 months]
• Duration of treatment response [Срок оценки: Up to 60 months]
• Time to treatment response [Срок оценки: Up to 60 months]
• Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) patient reported outcome (PRO) from baseline [Срок оценки: Baseline, and at 6, 12, 24, 36, 48, and 60 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 25 центров

• Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa — Mesa
• Local Institution - 0054 — La Jolla
• Local Institution - 0001 — La Palma
• Local Institution - 0071 — Los Angeles
• Rheumatology Center of San Diego — San Diego
• Centre for Rheumatology, Immunology and Arthritis — Fort Lauderdale
• South Florida Rheumatology — Hollywood
• LIFE Clinical Trials — Margate
• … и ещё 17 центров

Израиль · 6 центров

• Meir Medical Center — Kfar Saba
• Sheba Medical Center — Ramat Gan
• Rambam Medical Center — Haifa
• Carmel Medical Center — Haifa
• Rabin Medical Center - Hasharon Hospital — Petah Tikva
• Local Institution - 0025 — Tel Aviv

Великобритания · 5 центров

• Oxford University Hospitals NHS Trust - Churchill Hospital — Oxford
• Royal National Hospital for Rheumatic Diseases-Bath — Bath
• The Royal Wolverhampton NHS Trust - New Cross Hospital — Wolverhampton
• The Royal Free London NHS Foundation Trust - The Royal Free Hospital — London
• King's College Hospital NHS Foundation Trust — London

Аргентина · 4 центра

• Instituto Médico CER — Quilmes
• Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán
• Organización Médica de Investigación (OMI) — Buenos Aires
• Instituto De Reumatologia - IR Medical Center - Hospital de Dia — Mendoza

Канада · 4 центра

• Centre hospitalier de l'Université Laval — Calgary
• St. Joseph's Hospital — London
• The Ottawa Hospital - General Campus — Ottawa
• Local Institution - 0038 — Sherbrooke

Япония · 4 центра

• Local Institution - 0053 — Sendai
• Toyama University — Toyama
• Hospital of the University of Occupational and Environmental Health, Japan — Kitakyushu-Shi
• Local Institution - 0055 — Wakayama

Бразилия · 3 центра

• Local Institution - 0005 — Porto Alegre
• Local Institution - 0007 — Porto Alegre
• Local Institution - 0042 — São Paulo

Франция · 3 центра

• CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin — Bordeaux
• Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre — Strasbourg
• Hôpital Saint-Antoine — Paris

Италия · 3 центра

• Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna — Ferrara
• Azienda Ospedaliera Ordine Mauriziano di Torino — Torino
• ASST degli Spedali Civili di Brescia — Brescia

Швеция · 3 центра

• Local Institution - 0072 — Lund
• Local Institution - 0073 — Solna
• Local Institution - 0074 — Örebro

Германия · 2 центра

• Local Institution - 0041 — Kiel
• Local Institution - 0043 — Mainz

Испания · 2 центра

• Hospital de Merida — Mérida
• Hospital Clínic de Barcelona — Barcelona

Пуэрто-Рико · 1 центр

• Local Institution - 0046 — San Juan

Идентификаторы

NCT: NCT07175285 · CA061-1025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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