se of Tofacitinib and Adalimumab in Spondyloarthritis
- Conditions
- Health Condition 1: M450- Ankylosing spondylitis of multiplesites in spine
- Registration Number
- CTRI/2024/07/071400
- Lead Sponsor
- Indian Rheumatology Association
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method