Health Condition 1: M450- Ankylosing spondylitis of multiplesites in spine
Conditions
Interventions
Intervention1: Tofacitinib 5 mg once daily: Tofacitinib 5 mg once daily will be given from week 5 to week 20 after initial 4 weeks of Tofacitinib extended release 11 mg once daily
Control Intervention
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: The study recruits individuals aged 18-50 years who fulfill the ASAS classification criteria for Axial Spondyloarthritis. Patients should have active disease defined by BASDAI = 4 but have inadequate response to NSAIDs, received at least one NSAIDs for a total duration of at least 4 weeks. They should not have any thrombotic risk factors
Exclusion criteria
Exclusion criteria: Exclusion criteria include patients having access to anti-TNF or anti-IL17 biologics, those who are currently on JAK inhibitors or received them in the last 3 months, those who received anti-TNF or anti-IL17 in last 6 months, presence of uncontrolled or poorly controlled diabetes (HbA1c more than 7.0%) or hypertension (BP more than 160/100 mm Hg or requiring more than 2 antihypertensive drugs), prior major adverse cardiovascular events like myocardial infarction, stroke, angina, deep vein thrombosis or pulmonary thromboembolism, presence of active infection currently, malignancy in the past or currently,overt psoriasis or inflammatory bowel disease, chronic liver or kidney disease, those who are pregnant or planning for pregnancy in next 6 months, unwilling to participate in the study, cytopenia (Hemoglobin less than 7% and platelet less than 1 L per microlitre or WBC less than 4000 per microlitre, transaminitis (AST or ALT more than 50 IU/L), any other disease or past illness which is considered contraindication by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS20 responseTimepoint: 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ASDAS major improvement at 20 weeks. 2. Other Secondary outcomes will include BASDAI-50, ASAS40, ASAS clinically significant improvement all at 20 weeks. 3. Other outcomes will include delta-BASFI and delta-ASDAS at 4, 12 and 20 weeks.Timepoint: 20 weeks | — |
Countries
India
Contacts
Public ContactDr Bodhibrata Banerjee
Post Graduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed