Comparing Efficacy of Tofacitinib v/s Adalimumab In Axial Spondyloarthritis Randomised, Open Label, Non Inferiority Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- To compare ASAS 20 response rate among Tofacitinib and Adalimumab group in patients with Axial Spondyloarthritis
研究概览
简要总结
Background: Axial spondyloarthritis (axSpA), is a persistent inflammatory condition affecting the axial skeleton. Cytokines like TNF, IL-17, IL-23 are implicated in pathogenesis of AxSpA, but studies assessing their role as biomarkers of disease have conflicting results. Dickkopf-1 (DKK-1) is an inhibitor of Wnt signalling, which is a crucial pathway affecting bone formation and its deregulation plays a role in Spondyloarthritis. There is conflicting data on levels of DKK-1 in Spondyloarthritis and correlation of its level with treatment with TNF inhibitors & radiographic progression in Axial Spondyloarthritis. ASAS-EULAR recommends Non Steroidal Anti Inflammatory Agents [ NSAIDs] as first line for treatment of AS & options for failure of NSAIDs include Tumor Necrosis Factor Inhibitors [ TNFi], IL-17 Inhibitors, JAK-Inhibitors, but there are no head to head trials comparing efficacy of these agents.
Objectives: ASAS 20 response at week 12 in the study population receiving Adalimumab & Tofacitinib.
Methods: In this 12-week open-label, prospective, parallel arm study; 184 patients fulfilling Modified New York Criteria , ASAS criteria for Axial Spondyloarthritis, will be randomly assigned in a 1:1 ratio to receive Adalimumab or Tofacitinib, in combination with background therapy. The ASAS 20 response, other disease activity indices, change in SPARCC Score of SI Joint form baseline and adverse event profile will be compared. The correlation of IL-17, DKK-1 levels with treatment response & radiographic progression will be analysed.
Novelty: First study comparing Adalimumab & Tofacitinib correlating the serum IL-17, DKK-1 levels with treatment response & radiographic progression in Axial Spondyloarthritis.
Expected Outcomes: Tofacitinib is non inferior to Adalimumab in treatment of Axial Spondyloarthritis patients with no response to NSAIDs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •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.
排除标准
- •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.
结局指标
主要结局
To compare ASAS 20 response rate among Tofacitinib and Adalimumab group in patients with Axial Spondyloarthritis
时间窗: Week 12
次要结局
-  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)
研究者
Maddineni Abhi chandra
IMS and SUM Hospital