Bidirectional Cohort Study of Nanfang Spondyloarthritis

Recruiting

• Conditions: Spondyloarthritis (SpA); Ankylosing Spondylitis (AS)

• Registration Number: NCT06988813
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

Spondyloarthritis（SpA） patients attending Nanfang Hospital of Southern Medical University will generate a large number of clinical condition scales, laboratory indicators, imaging data such as X-rays or MRIs in the course of multiple standardized follow-up visits, as well as medical specimens from some of the patients who undergo surgical treatments. The Department of Orthopaedic Surgery of Nanfang Hospital is looking forward to the future and proposes to establish a specialized cohort named "Nanfang SpA Bidirectional Specialized Disease Cohort" by simply recording the clinical and imaging data of the above patients who have attended the clinic, been treated routinely, and have been followed up in the department without any interventional research measures. The cohort is proposed to: (1) archive the disease characteristics, biochemical index data, and disease assessment scales of all SpA patients attending the Southern Hospital; (2) record the X-ray and magnetic resonance imaging data of the patients to establish the "Southern SpA Imaging Dataset". This provides strong support for subsequent SpA research projects and lays the foundation for subsequent large-scale transect studies and retrospective studies.

Detailed Description

In this study, on the basis of not imposing randomized or interventional treatments and not generating additional examination tests on patients, the chronic disease data formed by multiple visits of SpA patients using conventional treatment regimens were used to form a bi-directional, disease-specific cohort by means of data entry alone, consisting of: one SpA condition information dataset, one SpA imaging dataset.

SpA condition information dataset: enter the disease duration, symptom characteristics, family history, comorbidities, previous medication use and efficacy of all outpatient diagnosed SpA patients; for each natural visit time point, establish BASDAI and ASDASCRP scores to assess the disease activity, assess the patient's physical functioning by BASFI scale, and EQ-5D and SF-36 scales to assess the quality of life; Recorded labs for each visit such as CRP, ESR and anti-streptococcal hemolysin O (ASO), anti-streptococcal DNAase B (ADNS). The subject group will not direct patients to lab tests that are not prescribed by the attending physician.

SpA imaging dataset: all imaging data of patients diagnosed with SpA and naturally attending our clinic were recorded, including: MRI of sacroiliac joints, MRI of hips, MRI of cervical/lumbar/thoracic spine, and orthopantomogram of pelvis, CT of sacroiliac joints, or vascular ultrasound of sacroiliac joints and lower limbs, and the imaging data were archived after preliminary SPARCC and SPARCC SSS scores were made. The subject group would not direct patients to examinations that were not prescribed by the attending physician.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study Start: 2025-05-17
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Primary Completion: 2030-04-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• 1.Attended Nanfang Hospital, Southern Medical University, 2010-2030 2.Prospective cohort study component: subjects voluntarily participate with informed consent and sign an informed consent form 3.Retrospective cohort study: (i) patients who visited the hospital from April 2010 to April 2024 (and who will not return to the hospital at a later date) were exempted from informed consent; (ii) patients who visited the hospital from May 2024 to April 2025 were required to sign an informed consent 4.10 years old ≤ age ≤ 59 years old 5.Patients with a standardized diagnosis of spondyloarthritis by the following guidelines or diagnostic criteria, i.e., meeting one of the following diagnostic criteria: (1) 2009 ASAS classification criteria for axial spondyloarthritis; (2) 2011 ASAS classification criteria for peripheral spondyloarthritis

Exclusion Criteria

• 1. Women who are pregnant, preparing for pregnancy or breastfeeding 2.Moderate to Severe Heart Failure (New York Heart Association Class 3-4) 3.Active peptic ulcers/bleeding 4.Judged by the investigator to be unsuitable for participation in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SpA dateset	From enrollment to the end of the follow-up at the 48th week	Collect a proprietary profile of clinical characteristics, laboratory and scale data, and imaging images from the Southern SpA Bi-directional Cohort for investigators to understand the natural history of the disease and to identify risk and prognostic factors for SpA.

Secondary Outcome Measures

Name	Time	Method
Disease activity score	From the start of enrollment, the follow-up time point was once every 3 months within the first year, and then once every 6 months within the subsequent 3 years	These include: Patient's Global Assessment, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score, C-reactive protein-based Ankylosing Spondylitis Disease Activity Score (ASDASCRP score), Bath Ankylosing Spondylitis Measurement Index (BASMI) score, Maastricht Ankylosing Spondylitis Attachment Spondylitis (MASES) score, Swollen Joint Count (Swollen Joint Count, 44 joint counts), Tender Joint Count (Tender Joint Count) (ASDASCRP score), Maastricht Ankylosing Spondylitis Attachment Spondylitis (MASES) score, Swollen Joint Count (Swollen Joint Count, 44 joints counted), Tender Joint Count (Tender Joint Count, 46 joints counted).
Quality of life score	From the start of enrollment, the follow-up time point was once every 3 months within the first year, and then once every 6 months within the subsequent 3 years	These include: Bath Ankylosing Spondylitis Functional Index (BASFI) Score, Quality of Survival Measurement for Ankylosing Spondylitis Patients (SQOL-AS), Short Form Health Survey (SF-36), BAS-G Score, Health Questionnaire for Spondyloarthritis (HAQ-S), Questionnaire of Productivity and Activity Impairment for Specific Health Problems (WPAI-SHP).
Imaging Evaluation	From the start of enrollment, the follow-up time point was once every 3 months within the first year, and then once every 6 months within the subsequent 3 years	Assessment of the severity of the condition on imaging (e.g., X-ray or MRI), such as: sacroiliac pathologic changes using the Spondyloarthritis Research Consortium of Canada Score(SPARCC), and spinal lesions using the Modified Stoke Ankylosing Spondylitis Spine Score(mSASSS).
Adverse events	From the start of enrollment, the follow-up time point was once every 3 months within the first year, and then once every 6 months within the subsequent 3 years	Record the type, frequency, and severity of all treatment-related adverse events, and use CTCAE criteria to categorize them for a comprehensive assessment of the safety of the consultation process.

Trial Locations

Locations (1)

Nanfang Hostipal,Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China