Health Condition 1: M450- Ankylosing spondylitis of multiplesites in spine
Conditions
Interventions
Intervention1: Tofacitinib: Tofacitinib 5mg, 1 tablet twice daily per oral for 12 weeks
Control Intervention1: Placebo: Identical looking multivitamin, 1 tablet twice daily per oral for 12 weeks
Sponsors
none
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and 2. Has active disease on screening at baseline defined by BASDAI >= 4 and Back pain score (BASDAI Question 2) of ï?³4. 3. Inadequate response to NSAID- Has received at least two NSAIDs for a total duration of at least 4 weeks and lack of sufficient clinical response based on clinical judgement. 4. Patients having intolerance to atleast two different oral NSAIDs. 5. Patient not affording for biologicals like TNF inhibitors or IL-17 inhibitors recommended for treatment of ankylosing spondylitis.
Exclusion criteria
Exclusion criteria: 1. Subjects that have been exposed to or are currently receiving JAK inhibitors or biological DMARDS 2. Blood dyscrasias at screening 2.1 Hemoglobin 2.2 Absolute white blood cell count (WBC) 2.3 Absolute neutrophil count (ANC) 2.4 Absolute lymphocyte count 2.5 Platelet count 3. Estimated Creatinine Clearance 4. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal (ULN) at screening 5. History of any other autoimmune rheumatic disease. 6. History of known or suspected complete ankylosis of the spine. 7. Patients having active tuberculosis or positive for latent tuberculosis as tested by QuantiFERON-TB Gold In Tube (QFT Gold test) or Montoux skin Test 8. History of recurrent herpes zoster or herpes simplex. 9. History of severe infection requiring hospitalization or parenteral antimicrobial therapy 10. History of lymphoproliferative disorder, such as Epstein Barr Virus related lymphoproliferative disease (EBV-LPD), history of lymphoma, leukemia 11. Patient with increased risk for GI perforation 12. Present malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. 13. Pregnant female or breast feeding mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the response of Assessment of SpondyloArthritis international Society â?¥20% improvement (ASAS20) at week 12 and its correlation with serum TNF-α and IL-17 levels.Timepoint: 12 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess ASDAS-CRP, BASDAI, BASMI, BASFITimepoint: 12 weeks;To assess ESR and CRPTimepoint: 12 weeks;To assess side effect profileTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactHARISH BV
IMS and SUM Hospital
Outcome results
None listed