Weddell Jake, Harrison Stephanie R, Bennett Alexander N, Gaffney Karl, Jones Gareth T, Machado Pedro M, Packham Jonathan, Sengupta Raj, Zhao Sizheng Steven, Siebert Stefan, Marzo-Ortega Helena
NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Rheumatol Adv Pract. 2024 Jul 26;8(3):rkae087. doi: 10.1093/rap/rkae087. eCollection 2024.
Timely diagnosis remains a challenge in axial SpA (axSpA). In addition, data are scarce on the impact of diagnostic delay and disease progression in affected individuals. The British Axial Spondyloarthritis Inception Cohort (BAxSIC) study aims to investigate the impact of newly diagnosed axSpA, the natural history of the disease and the effect of diagnostic delay on disease outcomes.
BAxSIC is a prospective, multicentre, observational study. Eligible participants are adults (≥16 years of age), with a physician-confirmed diagnosis of axSpA in the 6 months prior to study entry, recruited from secondary and tertiary rheumatology centres in the UK. Participants will be followed up for 3 years, with in-person visits at baseline and 24 months. In addition, patient self-reported assessments will be recorded remotely via the online electronic case report form (eCRF) at 6, 12, 18, 30 and 36 months.
The first patient was enrolled in BAxSIC in June 2023. Recruitment is currently ongoing and is planned to end in June 2026. Initial results will be available in 2027. Since opening, the trial has undergone two protocol amendments.
The BAxSIC study is the first inception cohort designed to investigate the impact of diagnostic delay on clinical presentation and long-term functional outcomes in patients with axSpA in the UK. With an innovative, patient-led virtual longitudinal data collection model, data generated from this study will help inform and improve the care of people newly diagnosed with axSpA.
ClinicalTrials.gov (http://clinicaltrials.gov), NCT05676775.
对于中轴型脊柱关节炎（axSpA），及时诊断仍是一项挑战。此外，关于诊断延迟和疾病进展对患者个体影响的数据十分匮乏。英国中轴型脊柱关节炎起始队列（BAxSIC）研究旨在调查新诊断的axSpA的影响、疾病的自然史以及诊断延迟对疾病结局的影响。
BAxSIC是一项前瞻性、多中心观察性研究。符合条件的参与者为成年人（≥16岁），在研究入组前6个月内经医生确诊为axSpA，从英国二级和三级风湿病中心招募。参与者将接受3年的随访，在基线和24个月时进行面对面访视。此外，患者自我报告的评估将在6、12、18、30和36个月时通过在线电子病例报告表（eCRF）进行远程记录。
首例患者于2023年6月纳入BAxSIC。目前招募工作仍在进行，计划于2026年6月结束。初步结果将于2027年公布。自开展以来，该试验已进行了两次方案修订。
BAxSIC研究是英国首个旨在调查诊断延迟对axSpA患者临床表现和长期功能结局影响的起始队列研究。通过创新的、以患者为主导的虚拟纵向数据收集模型，本研究产生的数据将有助于为新诊断的axSpA患者的护理提供信息并改善其护理。
ClinicalTrials.gov（http://clinicaltrials.gov），NCT05676775。
