Ankylosing Spondylitis (AS)
Conditions
Brief summary
This study is a multicentre, ambidirectional, observational cohort study. The ambidirectional design incorporates both the collection of retrospective data from the three years prior to enrolment, and a prospective follow-up period of up to two years. The study is designed to evaluate the long-term effects of Integrated Medicine on radiographic progression in patients diagnosed with Ankylosing spondylitis (AS).
Interventions
None listed
Sponsors
China-Japan Friendship Hospital
Henan Province Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Henan University of Chinese Medicine)
Guangxi Ruikang Hospital
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Beijing Electric Power Hospital
Hunan University of Traditional Chinese Medicine
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Xi'an Fifth Hospital
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* fulfill the 1984 modified New York criteria for ankylosing spondylitis or the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis * age between 18 and 75 years * sign informed consent.
Exclusion criteria
* diagnosis of other autoimmune diseases besides the disease under investigation (e.g., rheumatoid arthritis, Sjögren's syndrome, erythema nodosum, myositis, etc.) * pregnancy or lactation * comorbid severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, or malignancy * spondyloarthritis related to enteropathic arthritis, psoriatic arthritis, or reactive arthritis * unable to provide data due to mental, language, or similar factors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in Spondyloarthritis Research Consortium of Canada (SPARCC) scores from baseline to 12 months | Review the imaging data from up to three years prior to enrolment and assessed annually in the two-year follow-up period ahead. | The primary outcome measure assesses the changes in spinal inflammation following one year of Integrated Traditional Chinese and Western Medicine (Integrated Medicine) treatment. Select six consecutive vertebral units showing the most pronounced oedema (each unit comprising the vertebral body and the two inferior vertebral angles) for scoring; the total score ranges from 0 to 30 points. A reduction in the total score before and after treatment (e.g. from 20 to 8 points) indicates that the inflammation has been effectively controlled. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in SPARCC scores from baseline to 24 months | Review the imaging data from up to three years prior to enrolment and assessed at baseline and 24 months. | The change in SPARCC scores from baseline to 24 months, which is added to evaluate the longer-term durability of the treatment effect and to capture potential continued improvement or late-onset changes in spinal inflammation beyond the first year. |
| The longitudinal progression of spinal inflammation | Assessed annually in the two-year follow-up period ahead. | We will use the trajectory of SPARCC score changes at baseline, 12 months, and 24 months during the prospective follow-up to evaluate the longitudinal progression of spinal inflammatory lesions. |
| The Bath Ankylosing Spondylitis Functional Index (BASFI) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | To define and monitor physical functioning in patients with ankylosing spondylitis (AS). Score range is 0 - 10, with 0 reflecting no functional impairments and 10 reflecting maximal impairment. |
| The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | To measure patient-reported disease activity in patients with ankylosing spondylitis (AS). Score ranges from 0 (no disease activity) to 10 (maximal disease activity). A cut off of 4 is used to define active disease. High disease activity: BASDAI ≥ 4; low disease activity: \< 4. |
| The Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | To measure disease activity in ankylosing spondylitis (AS) based on a composite score of domains relevant to patients and clinicians, including both self-reported items and objective measures. Score ranges from 0 (reflecting no disease activity) with the upper end of the scale being determined by the level of the CRP. It defined 4 important disease states: inactive disease, moderate, high, and very high disease activity, and relevant cut offs between these states were 1.3, 2.1, and 3.5 units, respectively. Clinically important improvement was found to be 1.1 units or greater and major improvement was defined as a change of 2.0 units or more. |
| The Bath Ankylosing Spondylitis Metrology Index (BASMI) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | To quantify the mobility of the axial skeleton in ankylosing spondylitis (AS) patients and allow objective assessment of clinically significant changes in spinal movement. Score ranges from 0 to 10. A lower score indicates better mobility of the spine and hips, and less severe structural damage. A higher score indicates more severe joint ankylosis and restricted movement, and that the disease has caused significant structural consequences. |
| The Ankylosing Spondylitis Quality of Life Scale(ASQoL) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | To measure the impact of ankylosing spondylitis (AS) on health-related quality of life from the patient's perspective. Score range is 0-18. The score directly reflects the extent to which quality of life has been impaired; the lower the score, the better the quality of life has been maintained; conversely, the higher the score, the more severe the negative impact of the illness on quality of life. |
| The Visual Analogue Scale (VAS) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | To reflect the level of pain. Pain intensity is rated on a scale of 0 to 10. 0: no pain/absolutely none; 10: the most severe pain/unbearable, extreme discomfort. |
| Inflammatory marker: the serum C-reactive protein (CRP) levels | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | To monitor systemic inflammation and disease activity in patients with ankylosing spondylitis (AS). |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | AEs and SAEs including gastrointestinal reactions, abnormal liver and kidney function, and cardiovascular events. These conditions are monitored based on symptoms reported by patients, as well as routine blood and urine tests, faecal occult blood tests, liver and kidney function tests, and electrocardiograms. |
| Treatment adherence | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | Treatment adherence is assessed based on the use of traditional Chinese medicine (TCM) and Western medicine during the two-year follow-up period. |
| Time to discontinuation of Western medication | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | The time period from the first dose of Western treatment to the permanent discontinuation of any Western medicine (including non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs)) for ankylosing spondylitis (AS). |
| The use of non-steroidal anti-inflammatory drugs (NSAIDs) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | To assess the use of non-steroidal anti-inflammatory drugs (NSAIDs) by participants during the study period. |
Countries
China
Contacts
CONTACTYuanyuan Zou, Doctor
Outcome results
None listed