Efficacy of Mycophenolate Mofetil (MMF) as compared to Methotrexate for disease remission in Takayasu arteritis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- ITAS 2010 scoring of 0 or 1.
研究概览
简要总结
BACKGROUND
There are no clear guidelines on the treatment of Takayasu arteritis. The evidence we have is only in the form of case series or observational studies. Here we are performing a randomized control trial comparing the efficacy between Mycophenolate Mofetil and Methotrexate.
METHODS
Here we are randomly assigning the study population into two arms in the ratio of 1:1
The arms will be either the MMF group or the Methotrexate group after an informed consent. The baseline characteristics will be noted. Assessment will be done in the form of ITAS 2010 and ITAS 2010 CRP/ESR at the end of 3 months, 6 months and 9 months. The outcome assessor will be blinded to the study. The primary outcome will be the responders at the end of 9 months. Angiography will be done at the end of 9 months to assess the response. The cost effectiveness will also be calculated taking into account only the direct costs.
RESULTS:
The percentage of responders in both the arms will be noted. If there is a difference of 60 percent between the two arms, the trial will be stopped prematurely. Cost effectiveness will be calculated between the two arms by considering on the direct costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 17.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of Takayasu arteritis as per ACR/ Ishikawa criteria.
排除标准
- •Those who are on Azathioprine, MMF Methotrexate for more than 1 week, received Tocilizumab in the last 6 weeks Prednisolone at doses more than 10 mg for more than a month Pregnant ladies Any contraindication to MMF or Methotrexate (pre-existing renal or liver disease) However those who are on suboptimal doses of these medications and are still active at the time of presentation will be recruited.
结局指标
主要结局
ITAS 2010 scoring of 0 or 1.
时间窗: 9 months
If CRP is elevated at the time of any visit, which is clinically suspected to be due to causes like infection , it has to be repeated after 2 weeks before labeling it as failure
时间窗: 9 months
Responders at the end of 9 months as per the ITAS 2010 scoring
时间窗: 9 months
Responders will be defined as follows:
时间窗: 9 months
ITAS A(ESR/CRP) scoring of 1or 2
时间窗: 9 months
次要结局
- Time to respond in the two arms(To assess the angiographic response at 9 months.)