Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 22 April 2024
• Main ID: NCT03420404
• Date of registration: 16/01/2018
• Prospective Registration: Yes
• Primary sponsor: Singapore General Hospital
• Public title: Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis AcuSpA
• Scientific title: 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)
• Date of first enrolment: March 5, 2018
• Target sample size: 160
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03420404
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Singapore

Contacts

• Name: Lay Lian Tan

• Name: Warren Fong

• Name: Warren Fong
• Affiliation: Singapore General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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).



Age minimum: 21 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Axial Spondyloarthritis

Intervention(s)

Other: TCM physician involved collaborative care model (TCMCMC)

Primary Outcome(s)

Mean difference in spinal pain score [Time Frame: Week 6]

Secondary Outcome(s)

Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL) [Time Frame: Baseline, week 6, week 12, week 24]

Mean difference in costs of laboratory procedures [Time Frame: Week 6, week 12, week 24]

Mean difference in rheumatologist's consultation fees [Time Frame: Week 6, week 12, week 24]

Mean difference in spinal pain score [Time Frame: Week 12, week 24]

Mean difference in 36-Item Short Form Survey (SF-36) [Time Frame: Baseline, week 6, week 12, week 24]

Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time Frame: Baseline, week 6, week 12, week 24]

Mean difference in Health Assessment Questionnaire (HAQ) [Time Frame: Baseline, week 6, week 12, week 24]

Mean difference in number of inpatient days [Time Frame: Week 6, week 12, week 24]

Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) [Time Frame: Baseline, week 6, week 12, week 24]

Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G) [Time Frame: Baseline, week 6, week 12, week 24]

Secondary ID(s)

2017/2088

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Thong Chai Medical Institute Singapore

Saw Swee Hock School of Public Health

National University of Singapore

Duke-NUS Graduate Medical School