Status:
ACTIVE_NOT_RECRUITING
Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
Duke-NUS Graduate Medical School
Saw Swee Hock School of Public Health
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
21-100 years
Phase:
NA
Brief Summary
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 eith...
Detailed Description
The objective of this study is to determine the clinical effectiveness, safety and cost-effectiveness of a new model of care in the management of Spondyloarthritis (AxSpA) using a pragmatic trial appr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Pregnant or breastfeeding women
- On anti-platelet agents (i.e. aspirin, clopidogrel, dipyridamole, etc) and anti-coagulants (i.e. warfarin, enoxaparin, rivaroxaban, dabigatran, etc)
- Have bleeding disorders
- Have blood-borne communicable diseases (e.g. hepatitis B, hepatitis C, human immunodeficiency virus, etc).
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03420404
Start Date
March 5 2018
End Date
December 1 2025
Last Update
November 25 2025
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, Singapore, 169608