NCT03420404Active, not recruiting
Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis
A Pragmatic Randomized Controlled Trial of a Novel TCM Physician-involved Collaborative Care Model in the Management of Patients With Axial Spondyloarthritis in Singapore (AcuSpA)
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
A pragmatic, prospective, randomized controlled trial will be conducted in patients with axial spondyloarthritis who are NSAID inadequate responders. Patients will be randomized in a 1:1 ratio to either receive standard rheumatological care or a Traditional Chinese Medicine physician involved collaborative model of care (i.e. NSAIDs with acupuncture). Primary end-point was spinal pain score at week 6 with secondary end-points being evaluated week 24. Through this study, we hope to assess a novel model of care in AxSpA and be used as a reference to improve the management of other chronic diseases in Singapore.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 16 Jan 2018
- Start date
- 5 Mar 2018
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Singapore General Hospital
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT03420404
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From 5 Mar 2018 to the primary completion date, 30 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have bleeding disorders
- Have blood-borne communicable diseases (e.g. hepatitis B, hepatitis C, human immunodeficiency virus, etc).
Lab values
- On anti-platelet agents (i.e. aspirin, clopidogrel, dipyridamole, etc) and anti-coagulants (i.e. warfarin, enoxaparin, rivaroxaban, dabigatran, etc)
Other
- Pregnant or breastfeeding women
Who the study is looking for
- 21 years of age or older
- Have AxSpA, diagnosed according to the 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria
- Have active disease based on Bath AS Disease Activity Index (BASDAI) score ≥4 on a 11-point Numerical Rating Scale (NRS) and spinal pain score ≥4 on a 11-point NRS
- Has failed 2 sequential NSAIDs (including COX-2 inhibitor) at maximal tolerated doses for ≥ 4 weeks
- No biologic therapy (i.e tumour necrosis factor blocker or anti-interleukin 17) within the past three months
- Patient who is on current treatment with concomitant methotrexate (MTX) or sulfasalazine (SSZ) at study entry must be on the drug for ≥12 weeks and at stable dose for ≥4 weeks prior to randomisation. Patients who are on non-biologic disease-modifying antirheumatic drugs (DMARDs) other than methotrexate or sulfasalazine must discontinue the DMARD 4 weeks prior to randomisation, except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine washout has been performed. Patients taking systemic corticosteroids have to be on stable dose of ≤ 10mg/day prednisolone or equivalent for at least two weeks before randomisation
Age in the registry: 21 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Singapore General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.