Efficacy and safety of Tofacitinib in Ankylosing Spondylitis and its correlation with Serum Cytokines- A randomized, double- blind, placebo controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the response of Assessment of SpondyloArthritis international Society ≥20% improvement (ASAS20) at week 12 and its correlation with serum TNF-α and IL-17 levels.
研究概览
简要总结
Axial spondyloarthropathies (axSpA) are a spectrum of chronic inflammatory diseases affecting primarily the axial skeleton (sacroiliac joints and spine). The first line treatment for ankylosing spondylitis recommended is non-steroidal anti-inflammatory drugs (NSAIDs) and non-pharmacological approaches such as education and physiotherapy. In patients whose disease is still active or by reasons are intolerant to or contraindicated for NSAIDs, tumour necrosis factor (TNF) α inhibitors or IL-17 inhibitors are recommended
Tofacitinib is a JAK inhibitor approved for the treatment of many rheumatology rheumatological diseases like Rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, polyarticular course juvenile idiopathic arthritis. Here in this study we attempt to look for the safety and efficacy of tofacitinib in the management of NSAID refractory, biologicals non affording patients with active ankylosing spondylitis and its correlation with serum cytokine levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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 
- •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.
排除标准
- •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.
结局指标
主要结局
To assess the response of Assessment of SpondyloArthritis international Society ≥20% improvement (ASAS20) at week 12 and its correlation with serum TNF-α and IL-17 levels.
时间窗: 12 WEEKS
次要结局
- To assess ASDAS-CRP, BASDAI, BASMI, BASFI(12 weeks)
- To assess ESR and CRP(12 weeks)
- To assess side effect profile(12 weeks)