| CTRI Number |
CTRI/2017/10/010069 [Registered on: 12/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Which drug is better in Takayasu arteritis- Mycophenolate Mofetil or Methotrexate? |
|
Scientific Title of Study
|
Efficacy of Mycophenolate Mofetil (MMF) as compared to Methotrexate for disease remission in Takayasu arteritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivraj Padiyar U |
| Designation |
Senior PG Registrar |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Clinical Immunology and Rheumatology, Christian Medical College Hospital campus, Ida Schudder Road
Vellore
TAMIL NADU
632004
India |
| Phone |
7373971448 |
| Fax |
|
| Email |
uspshiv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEBASHISH DANDA |
| Designation |
Professor and Head of the Department of Rheumatology |
| Affiliation |
Christian Medical College , Vellore |
| Address |
Department of Clinical Immunology and Rheumatology, Christian Medical College Hospital campus, Ida Schudder Road
Vellore
TAMIL NADU
632004
India |
| Phone |
7373971448 |
| Fax |
|
| Email |
debashisdandacmc@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivraj Padiyar U |
| Designation |
Senior PG Registrar |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Clinical Immunology and Rheumatology, Christian Medical College Hospital campus, Ida Schudder Road
Vellore
TAMIL NADU
632004
India |
| Phone |
7373971448 |
| Fax |
|
| Email |
uspshiv@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPCA Laboratories limited, Mumbai
APLAR grant |
|
|
Primary Sponsor
|
| Name |
IPCA Laboratories Limited |
| Address |
Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHIVRAJ PADIYAR U |
Christian Medical College, Vellore |
Department of Clinical Immunology and Rheumatology, 900 room
Vellore
TAMIL NADU |
7373971448
uspshiv@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD , CMC VELLORE |
Approved |
| Institutional Review Board, Christian Medical College, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M314||Aortic arch syndrome [Takayasu], Stable, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Methotrexate |
Starting dose of 15 mg weekly for one month followed by 20 mg weekly to continue. The tablet is given orally |
| Intervention |
Mycophenolate Mofetil |
1 g twice daily and maintain MPA (MMF) levels between 30-60 mcg/ml. The tablet is given orally |
|
Inclusion Criteria
Modification(s)
|
| Age From |
17.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Takayasu arteritis as per ACR/ Ishikawa criteria |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
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 failure |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to respond in the two arms
To assess the angiographic response at 9 months.
|
3,6,9 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/06/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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. |