Health Condition 1: M450- Ankylosing spondylitis of multiplesites in spine
Conditions
Interventions
Intervention1: Tofacitinib: Tablet tofacitinib 5mg twice daily is given for 12 weeks
Control Intervention1: Adalimumab: Injection adalimumab 40mg is given subcutaneously for every 2 weeks for total of
Sponsors
Indian Rheumatology Association
Eligibility
Inclusion criteria
Inclusion criteria: Aged between 18 to 60 years fulfilling the Modified New York Criteria for Ankylosing Spondylitis (1984) & ASAS criteria for Axial Spondyloarthritis High Disease Activity defined by ASDAS = 2.1. Intolerance or inadequate response to at least two different oral NSAIDS, given maximum dose for a total duration of at least 4 weeks. All patients must give written informed consent prior to enrolment
Exclusion criteria
Exclusion criteria: Patient with previous history of biological usage Past or present history of Inflammatory Bowel Disease Past or present history of Psoriasis Blood dyscrasias - anemia, leucopenia, thrombocytopenia Renal insufficiency Liver Insufficiency- Bilirubin & liver enzymes more than 1.5 times the upper limit of normal (ULN) at screening Complete ankylosis of the spine. Patients having active tuberculosis or positive for latent tuberculosis Latent Hepatitis B Positive status [ Anti HBc Ig positive] History of recurrent herpes zoster or herpes simplex. Present malignancy or with a history of malignancy Current or past history thromboembolism or presence of risk factors for the same. History of Coronary artery disease or presence of risk factors for cardiovascular disease Pregnant female or breast-feeding mothers H/O or current demyelinating Disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare ASAS 20 response rate among Tofacitinib and Adalimumab group in patients with Axial SpondyloarthritisTimepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| ? To compare ASAS 40 response rate among Tofacitinib & Adalimumab patients group. ? Mean Change in disease activity assessed by BASDAI; BASMI; ASDAS – CRP; BASFI; MASES; SJC 44; ESR ; CRP; SPARCC Score – SI Joint ? Mean Change in serum DKK-1, IL-17 levels ? Adverse events Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactPradeepta Sekhar Patro
IMS and SUM Hospital
Outcome results
None listed