Efficacy and safety of Tofacitinib in Ankylosing Spondylitis and its correlation with Serum Cytokines- A randomized, double- blind, placebo controlled trial.

none0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年5月30日

试验速览

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•1.Age >= 18 years and < 60 years satisfying presence of Ankylosing Spondylitis based on the Modified New York Criteria for Ankylosing Spondylitis (1984).
•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.

•1.Subjects that have been exposed to or are currently receiving JAK inhibitors or biological DMARDS
•2.Blood dyscrasias at screening
•2.1Hemoglobin <10 g/dL
•2.2Absolute white blood cell count (WBC) <3.0 x 109/L ( <3000 mm3)
•2.3Absolute neutrophil count (ANC) <1.5 x 109/L ( <1500 mm3)
•2.4Absolute lymphocyte count <1.0 x 109/L ( <1000/mm3)
•2.5Platelet count <100 x 109/L ( <100,000/mm3)
•3.Estimated Creatinine Clearance <40 mL/min based on Cockcroft Gault equation at Screening
•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.

发起方

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