Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Rheumatoid Arthritis (RA). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Норвегия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The ARCTIC REWIND Extension Study - Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission
Обзор
The goal of this multi-center prospective observational study is to develop knowledge on how to best personalize treatment and follow-up strategies for patients with RA in remission, with the intention to prevent relapse of disease activity and progression of joint damage and at the same time avoid the use of unnecessary treatment and health resources. The investigators will perform an extensive evaluation of all patients who participated in the ARCTIC REWIND study 10 and 15 years after they achieved sustained remission and received different treatment strategies.
Подробное описание
Rheumatoid Arthritis (RA) is a chronic inflammatory disease that affects 0.5 to 1.0% of the population. In case of ineffective treatment, the inflammation can lead to joint destruction and reduced physical function, as well as affecting internal organs. RA is associated with an increased risk of cardiovascular disease and osteoporosis.
The prognosis for RA has improved significantly over the past two decades, with effective treatment strategies and available drugs allowing a significant proportion of patients to achieve the treatment goal of remission (absence of signs of inflammation). RA has thus become a 'controllable' disease, and the large increase in the number of RA patients in remission leaves a need for improved understanding of how to best treat these patients.
A total of 259 RA patients in sustained remission were included in the ARCTIC REWIND trial. They were randomized to either tapering of DMARDs, or to continue stable DMARD medication, and followed for three years. The current study will provide a 10- and 15-year follow-up on the outcome of all these patients.
The results from the project will add knowledge about the long-term consequences of achieving sustained remission, as well as of experiencing a disease activity flare regarding DMARD use, joint damage progression, functional status and work productivity, and the study will provide novel data on cardiovascular health and other comorbidities in this patient group. Further, the patient perspective on flare will be explored. Such information will be valuable for patients and clinicians to improve shared decision on further treatment, and potentially allow more patients to reduce treatments in an evidence-based manner. Results from the study could influence approaches to the management of RA in the future, as selecting patients who can be switched to remote care (reduce the number of visits the patient has to attend physically).
Первичные конечные точки
- Disease activity remission status [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Disease Modifying Anti-Rheumatic Drug (DMARD)-free remission [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Radiographic score (van der Heijde modified Sharp score (vdHSS) [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Radiographic joint damage progression [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Disease activity composite measures [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Patient reported physical function [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
Вторичные конечные точки (12)
- Health-related quality of life [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Patient global assessment of disease activity [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Physician global assessment of disease activity [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Ultrasound inflammation [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Swollen joint count [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Tender joint count [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Tender joints [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Osteoporosis [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Medication use [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Physical and mental health [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Patient reported impact of disease [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
- Work performance and status [Срок оценки: Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial]
Критерии участия
Критерии включения
- Participation in the ARCTIC REWIND trial
- Patients able and willing to give written informed consent and comply with the requirements of the study protocol
Критерии исключения
- Psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Норвегия · 10 центров
- Ålesund Hospital — Ålesund
- Haukeland University Hospital — Bergen
- Vestre Viken Hospital — Drammen
- Sørlandet Hospital — Kristiansand
- Revmatismesykehuset — Lillehammer
- Helgelandssykehuset Mo i Rana — Mo i Rana
- Østfold Hospital — Moss
- Diakonhjemmet Hospital — Oslo
- … и ещё 2 центра
Идентификаторы
NCT: NCT06783322 · DS-00887