Which drug is better in Takayasu arteritis- Mycophenolate Mofetil or Methotrexate?
Phase 3
- Conditions
- Health Condition 1: M314- Aortic arch syndrome [Takayasu]Health Condition 2: null- Stable
- Registration Number
- CTRI/2017/10/010069
- Lead Sponsor
- IPCA Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients of Takayasu arteritis as per ACR/ Ishikawa criteria
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Responders at the end of 9 months as per the ITAS 2010 scoring <br/ ><br>Responders will be defined as follows: <br/ ><br>ITAS 2010 scoring of 0 or 1. <br/ ><br>ITAS A(ESR/CRP) scoring of 1or 2 <br/ ><br> <br/ ><br>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 failureTimepoint: 9 months
- Secondary Outcome Measures
Name Time Method Time to respond in the two arms <br/ ><br>To assess the angiographic response at 9 months. <br/ ><br>Timepoint: 3,6,9 months