Bidirectional Cohort Study of Nanfang Spondyloarthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-59
SponsorNanfang Hospital, Southern Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Spondyloarthritis (SpA) is a group of diseases characterized by inflammation of the sacro-skeletal joints and the tendon attachment points of the spine and peripheral joints, etc. The course of SpA is characterized by gradual progression, and it is divided into three main stages, from mild to severe, namely, undifferentiated SpA (uSpA), sacroiliac arthritis, and AS. The uSpA stage is characterized by a gradual progression.In the uSpA stage, the only manifestations are fat metaplasia or inflammation of the attachment points of the sacroiliac joints, while in the sacroiliac arthritis stage, subchondral intramedullary edema of the sacroiliac joints develops, and in the AS stage, sacroiliac erosion and fusion of the joints occur.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 2 trial groupsGroup A: Retrospective cohort
Group B: Prospective cohort
Trial outcomes
Primary outcomes
1
SpA dateset
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.
Time frame
From enrollment to the end of the follow-up at the 48th weekSecondary outcomes
1
Disease activity score
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).
Time frame
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 years2
Quality of life score
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).
Time frame
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 years3
Imaging Evaluation
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).
Time frame
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 years4
Adverse events
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.
Time frame
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nanfang Hospital, Southern Medical University
Lead sponsor
Southern Medical University, China
Collaborator
Source ClinicalTrials.gov