Efficacy of half-dose Tofacitinib in Axial Spondyloarthritis- a double blind randomised controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ASAS20 response
研究概览
简要总结
This study is a randomized double-blind active parallel group trial. The study duration is 20 weeks.100 patients fullfilling the ASAS classification criteria for Axial Spondyloarthritis between ages 18-50 years who have active disease as defined by BASDAI > 4 will be recruited from outpatient department of Internal Medicine and Rheumatology clinic of Post Graduate Institute of Medical Education and Research, Chandigarh. All of them will get 11 mg of tablet Tofacitinib extended release preparation for initial 4 weeks. After that, following randomisation and concealment, 50 individuals (intervention arm) will get Tofacitinib 5 mg once daily and the other 50 (comparator arm) will be continued on Tofacitinib 11 mg extended release from week 5 to week 20 that is the rest of the study period. At the end of 20 weeks, achievement of ASAS20 in both the groups will be assessed. Key secondary outcome measure will include ASDAS major improvement at 20 weeks, BASDAI-50, ASAS40, ASAS clinically significant improvement all at 20 weeks delta-BASFI and delta-ASDAS at 4, 12 and 20 weeks. Tofacitinib tablets will be supplied to the patients free of cost by IPCA pharmaceuticals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •The study recruits individuals aged 18-50 years who fulfill the ASAS classification criteria for Axial Spondyloarthritis.
- •Patients should have active disease defined by BASDAI ≥ 4 but have inadequate response to NSAIDs, received at least one NSAIDs for a total duration of at least 4 weeks.
- •They should not have any thrombotic risk factors.
排除标准
- •include patients having access to anti-TNF or anti-IL17 biologics, those who are currently on JAK inhibitors or received them in the last 3 months, those who received anti-TNF or anti-IL17 in last 6 months, presence of uncontrolled or poorly controlled diabetes (HbA1c more than 7.0%) or hypertension (BP more than 160/100 mm Hg or requiring more than 2 antihypertensive drugs), prior major adverse cardiovascular events like myocardial infarction, stroke, angina, deep vein thrombosis or pulmonary thromboembolism, presence of active infection currently, malignancy in the past or currently,overt psoriasis or inflammatory bowel disease, chronic liver or kidney disease, those who are pregnant or planning for pregnancy in next 6 months, unwilling to participate in the study, cytopenia (Hemoglobin less than 7% and platelet less than 1 L per microlitre or WBC less than 4000 per microlitre, transaminitis (AST or ALT more than 50 IU/L), any other disease or past illness which is considered contraindication by the physician.
结局指标
主要结局
ASAS20 response
时间窗: 20 weeks
次要结局
- 1. ASDAS major improvement at 20 weeks.(2. Other Secondary outcomes will include BASDAI-50, ASAS40, ASAS clinically)
研究者
Dr Bodhibrata Banerjee
Post Graduate Institute of Medical Education and Research, Chandigarh