Bidirectional Cohort Study of Nanfang Spondyloarthritis

NCT06988813 | Recruiting

• 1 other identifier: NFEC-2025-228
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthritis (SpA); Ankylosing Spondylitis (AS)

Keywords

Bidirectional Cohort

Outcome Measures

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.

  From enrollment to the end of the follow-up at the 48th week

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Retrospective cohort

Patients between May 2024 and April 2025 were required to sign an up-to-date Ethics Committee-approved Informed Consent Form (ICF) prior to data collection, and all clinical data were collected at once. Patients with visits from April 2010 to April 2024 (and who will not return to the hospital at a later date) will be exempted from informed consent for this study, as the information involved in the visit will come from the medical record of the clinical visit, the risk to the subject is no more than minimal, the exemption from informed consent will not adversely affect the patient's rights or health and the study will not be able to proceed if informed consent is obtained, and subjects' privacy and personally identifiable information will be protected. Subjects' privacy and personally identifiable information will be protected.

Prospective cohort

Patients will be required to sign an up-to-date Ethics Committee-approved Informed Consent Form (ICF) prior to data collection. After obtaining informed consent from patients, information on routine clinical visits will be collected, and the number and timing of study visits will follow the time points for routine clinical patient review. The time points for routine clinical review will be: every 3 months for 1 year and every 6 months for 3 years after treatment, for a total of 4 years.

Eligibility Criteria

• Age: 10 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Southern Medical University, China: collaborator

Study Sites (1)

Nanfang Hostipal,Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Spondylarthritis; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Spondylarthropathies; Ankylosis

Central Study Contacts

Jun Xiao, Dr

CONTACT

0086-20-18665000156; orthopaedxj@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: May 17, 2025
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

CN (1)