Health Condition 1: M450- Ankylosing spondylitis of multiplesites in spine
Conditions
Interventions
Intervention1: Oral Tablet Tofacitinib: 5mg twice daily for 4 months
Control Intervention1: Injection Adalimumab: 40mg subcutaneously every 2 weekly for 4 weeks
Sponsors
Institute of post graduate graduate medical education and research
Eligibility
Inclusion criteria
Inclusion criteria: Patients fulfilling the ASAS classification criteria for axial SpA including both non radiographic axial spondyloarthritis (nr-AxSpA) and ankylosing spondylitis (AS) Patients with BASDAI =4 or ASDAS-CRP=2.1. Biologic DMARD (b DMARD) and targeted synthetic DMARD (ts DMARD) naïve patients who have undergone a trial of at least 2 courses of NSAIDs with optimum doses for at least 1 month without response or with partial response. Patients with prior b DMARD and ts DMARD permitted if discontinued for =4 weeks or =5 half-lives (whichever was longer) before randomization.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS20 responseTimepoint: ASAS20 response | — |
Secondary
| Measure | Time frame |
|---|---|
| ASAS 5/6 responseTimepoint: 4,8,12 and 16 weeks;ASAS20 responseTimepoint: 4, 8, 12 and 16 weeks;ASAS40 responseTimepoint: 4,8, 12 and 16 weeks;BASDAI50 responseTimepoint: 4,8,12 and 16 weeks;Change in ASADASCRPTimepoint: 4,8,12 and 16 weeks;Change in ASQoLTimepoint: 16 weeks;Change in BASDAITimepoint: 4,8,12 and 16 weeks;Change in BASFITimepoint: 16 weeks;Change in BASMITimepoint: 16 weeks;Change in hsCRPTimepoint: 4,8,12 and 16 weeks;Change in MASESTimepoint: 4,8,12 and 16 weeks;Change in patient global assessmentTimepoint: 4,8,12 and 16 weeks;Change in swollen joint countTimepoint: 4,8,12 and 16 weeks;Incident and severity of adverse effectsTimepoint: 4,8,12 and 16 weeks;NSAID useTimepoint: 4,8,12 and 16 weeks | — |
Countries
India
Contacts
Public ContactMonika G
IPGMER and SSKM hospital
Outcome results
None listed