Health Condition 1: M314- Aortic arch syndrome [Takayasu] Health Condition 2: null- Stable
Conditions
Interventions
Intervention1: Mycophenolate Mofetil: 1 g twice daily and maintain MPA (MMF) levels between 30-60 mcg/ml. The tablet is given orally
Control Intervention1: Methotrexate: Starting dose of 15 mg weekly
Sponsors
IPCA Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients of Takayasu arteritis as per ACR/ Ishikawa criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responders at the end of 9 months as per the ITAS 2010 scoring Responders will be defined as follows: ITAS 2010 scoring of 0 or 1. ITAS A(ESR/CRP) scoring of 1or 2 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
| Measure | Time frame |
|---|---|
| Time to respond in the two arms To assess the angiographic response at 9 months. Timepoint: 3,6,9 months | — |
Countries
India
Contacts
Public ContactDr Shivraj Padiyar U
Christian Medical College , Vellore
Outcome results
None listed