Ankylosing Spondylitis (AS)NCT07509775
Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis (AS): A Cohort Study Protocol Focusing on Spondyloarthritis Research Consortium of Canada (SPARCC) Scoring System
An observational study of Ankylosing Spondylitis (AS), run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ankylosing Spondylitis (AS)
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2026to 30 Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Ankylosing spondylitis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
Yuqiao Zhang, Doctor, +86 13520678396, 13661102043@163.com
About this study
Official title: Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis: A Cohort Study Protocol Focusing on Spondyloarthritis Research Consortium of Canada (SPARCC) Scoring System
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).
- Conditions
- Ankylosing Spondylitis (AS)
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| exposed group | Participants who receive traditional Chinese medicine (TCM) therapy for more than 60% of the total duration of their prospective follow-up period. | |
| non-exposed group | Participants who do not receive any TCM therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Spondyloarthritis Research Consortium of Canada (SPARCC) scores from baseline to 12 months
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.
Measured: Review the imaging data from up to three years prior to enrolment and assessed annually in the two-year follow-up period ahead.
Secondary outcomes (13)
The change in SPARCC scores from baseline to 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.
Measured: Review the imaging data from up to three years prior to enrolment and assessed at baseline and 24 months.
The longitudinal progression of spinal inflammation
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.
Measured: Assessed annually in the two-year follow-up period ahead.
The Bath Ankylosing Spondylitis Functional Index (BASFI)
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.
Measured: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
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.
Measured: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
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.
Measured: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The Bath Ankylosing Spondylitis Metrology Index (BASMI)
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.
Measured: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The Ankylosing Spondylitis Quality of Life Scale(ASQoL)
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.
Measured: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The Visual Analogue Scale (VAS)
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.
Measured: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Inflammatory marker: the serum C-reactive protein (CRP) levels
To monitor systemic inflammation and disease activity in patients with ankylosing spondylitis (AS).
Measured: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
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.
Measured: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Treatment adherence
Treatment adherence is assessed based on the use of traditional Chinese medicine (TCM) and Western medicine during the two-year follow-up period.
Measured: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Time to discontinuation of Western medication
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).
Measured: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The use of non-steroidal anti-inflammatory drugs (NSAIDs)
To assess the use of non-steroidal anti-inflammatory drugs (NSAIDs) by participants during the study period.
Measured: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start19 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, Guangxi Ruikang Hospital, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Beijing Electric Power Hospital, The First Affiliated Hospital of 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, Longhua Hospital, Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital
- Responsible party
- Principal investigator, Qingwen Tao, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509775
- Sponsor's protocol ID
- 2025-KY-458
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No