Health Condition 1: M450- Ankylosing spondylitis of multiplesites in spine
Conditions
Interventions
Intervention1: Tofactinib 5 mg TID: Randomly assigned 1:1 ratio and to continue standard-dose tofacitinib (5mg given twice daily)
Control Intervention1: Tofacitinib 5 mg BD with 5 mgOD A/D(Tappering d
Sponsors
Dr Padmanabha Shenoy D
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients aged 18 years to 50 years, with a diagnosis of radiographic axial spondyloarthritis
Exclusion criteria
Exclusion criteria:
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the time to first flare between the two arms 2.To compare the change in ASDAS-CRP versus baseline at 32 weeks 3.To compare physical function and quality of life between the groups 4.To identify predictors of successful tapering Timepoint: 32 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether a structured tapering strategy for tofacitinib is non-inferior to continued standard-dose tofacitinib (5mg twice daily) in sustaining flare-free remission at 16 weeks.Timepoint: 16 weeks | — |
Countries
India
Contacts
Public ContactDr Padmanabha Shenoy D
Sree Sudheendra Medical Mission
Outcome results
None listed