A clinical study to compare the effect of two drugs, Tofacitinib and Adalimumab in axial spondyloarthritis patients
Phase 3
- Conditions
- Health Condition 1: M450- Ankylosing spondylitis of multiplesites in spine
- Registration Number
- CTRI/2024/04/065955
- Lead Sponsor
- Institute of post graduate graduate medical education and research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ASAS20 responseTimepoint: ASAS20 response
- Secondary Outcome Measures
Name Time Method 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