INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use

Официальное название

INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice

Обзор

INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion/exclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study.

Подробное описание

INTERSTELLAR is a multi-country, single-arm, observational, cohort study, with 1 year retrospective baseline data and 1 year of prospective follow-up. The study will be initiated on a country-by-country basis following the commercial launch of anifrolumab. The enrolment period is anticipated to be 12 months per country. In general, patients will enter the study between the first anifrolumab prescription and infusion (index), with follow-up until death, loss to follow-up, patient discontinuing the study, or end of study period (whichever occurs first). Relevant clinical and patient reported outcome (PRO) data collection for the entire follow up will continue for patients who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study

Первичные конечные точки

• PGA [Срок оценки: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12]
• SLEDAI-2K [Срок оценки: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12]
• CLASI [Срок оценки: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12]
• FACIT-Fatigue [Срок оценки: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12]
• LupusQoL [Срок оценки: Baseline (pre-infusion) Month 3, Month 6, Month 12]
• EQ-5D-5L [Срок оценки: Baseline (pre-infusion) Month 3, Month 6, Month 12]

Критерии участия

Критерии включения

• Aged 18 years or older at study enrolment.
• Fulfilled the 2019 EULAR/ACR criteria1 for SLE at the time of study entry.
• Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.
• It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion.
• In countries where prescription reimbursements are authorized on a case-by-case basis, authorization (ie, patient access to treatment) will be required for study entry.
• Provided informed consent to participate in the study.
• Willing and able to participate in all required study evaluations and procedures.

Критерии исключения

• Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product.
• Previous exposure to anifrolumab as part of a clinical trial or early access program.
• Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \[MMF\]/cyclophosphamide \[CYC\] + high dose steroids), isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus.
• Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Казахстан · 8 центров

• Research Site — Aktobe
• Research Site — Almaty
• Research Site — Almaty
• Research Site — Astana
• Research Site — Astana
• Research Site — Pavlodar
• Research Site — Semey
• Research Site — Shymkent

Китай · 5 центров

• Research Site — Гуанчжоу
• Research Site — Гонконг
• Research Site — Шэньчжэнь
• Research Site — Zhongshan
• Research Site — Zhuhai

Тайвань · 5 центров

• Research Site — Kaohsiung City
• Research Site — Taichung
• Research Site — Taichung
• Research Site — Taipei
• Research Site — Taoyuan

Саудовская Аравия · 3 центра

• Research Site — ASIR
• Research Site — Jeddah
• Research Site — Riyadh

Аргентина · 2 центра

• Research Site — Buenos Aires
• Research Site — Córdoba

Египет · 2 центра

• Research Site — Alexandria
• Research Site — Cairo

Мексика · 2 центра

• Research Site — Mexico City
• Research Site — Mérida

Costa Rica · 1 центр

• Research Site — San José

Guatemala · 1 центр

• Research Site — Guatemala City

Кувейт · 1 центр

• Research Site — Kuwait City

Oman · 1 центр

• Research Site — Muscat

Катар · 1 центр

• Research Site — Doha

Идентификаторы

NCT: NCT06314282 · D3461R00072

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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