Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT03420404
Eligibility 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
100 Years
Study:
NCT03420404
Study Brief:
Protocol Section:
NCT03420404