Comparing Efficacy of Tofacitinib v/s Adalimumab In Axial Spondyloarthritis Randomised, Open Label, Non Inferiority Trial - NI

Indian Rheumatology Association0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•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

发起方

Indian Rheumatology Association