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CTRI Number  CTRI/2025/01/079091 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 20/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effectiveness of low dose Colchicine therapy controlling disease activity in patients with Takayasu arteritis who have continued ongoing inflammation in the blood  
Scientific Title of Study   Efficacy and safety of addition of Low-dose Colchicine in Takayasu arteritis with persistent systemic inflammation: a multi-institutional Randomized controlled trial 
Trial Acronym  CoTA Co stands for Colchicine in TA stands for Takayasu Arteritis  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ruchika Goel 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Clinical Immunology and Rheumatology, Christian Medical College, Vellore- 632004

Vellore
TAMIL NADU
632004
India 
Phone  09790896246  
Fax    
Email  ruchika.goel@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Ruchika Goel 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Clinical Immunology and Rheumatology, Christian Medical College, Vellore- 632004


TAMIL NADU
632004
India 
Phone  09790896246  
Fax    
Email  ruchika.goel@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Ruchika Goel 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Clinical Immunology and Rheumatology, Christian Medical College, Vellore- 632004


TAMIL NADU
632004
India 
Phone  09790896246  
Fax    
Email  ruchika.goel@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, New Delhi  
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  Indian Council of Medical Research Department of Health Research Ministry of Health & Family Welfare Government of India Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ranjan Gupta   All India Institute of Medical Sciences, Delhi   Department of Rheumatology, All India Institute of Medical Sciences (AIIMS), New Delhi - 110029. India
New Delhi
DELHI 		 9899390715

dr.guptaranjan@gmail.com 
Dr Ruchika Goel   Christian Medical College, Vellore   Department of Clinical Immunology and Rheumatology, Christian Medical College, Vellore- 632004
Vellore
TAMIL NADU 		 9790896246

ruchika.goel@cmcvellore.ac.in 
Dr Molly Mary Thabah  Jawaharlal Institute of Postgraduate Medical Education and Research  Department of Clinical Immunology, JIPMER Campus Rd, JIPMER Campus, Puducherry, 605006
Pondicherry
PONDICHERRY 		 8903200854

thabah.m@jipmer.edu.in 
Dr Sakir Ahmed   Kalinga Institute of Medical Sciences   Department of Clinical Immunology and Rheumatology, Kalinga Institute of Medical Sciences, Kusabhadra Campus, KIMS Rd, Chandaka Industrial Estate, K I I T University, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA 		 9706023644

sakir005@gmail.com 
Dr Devarasetti Phanikumar  Nizams Institute of Medical Sciences   Department of Clinical Immunology and Rheumatology, NIMS, Punjagutta, Hyderabad-500082
Hyderabad
TELANGANA 		 9866539874

dphanimbbs@gmail.com 
Dr Aradhana Singh   Sawai Man Singh Medical College, Jaipur  Department of Clinical Immunology and Rheumatology, SMS Medical College, Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004
Jaipur
RAJASTHAN 		 9166916692

aradhanas610@yahoo.com 
Dr Ramya Janardhana   St. Johns Medical College and hospital, Bengaluru  Department of Clinical Immunology and Rheumatology, St. Johns Medical College and hospital, Sarjapur Road, Bengaluru- 34
Bangalore
KARNATAKA 		 9566329392

ramyaaithala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
AIl India Institute of Medical Sciences  Approved 
Institutional reveiw board and Ethics committee Christian Medical College Vellore  Approved 
Jawaharlal Institute of Post Graduate Medical Education and Research  Approved 
Kalinga Institute of Medical Sciences   Approved 
NIMS institutional ethics committee  Approved 
Saint Johns Institute of Medical Sciences  Approved 
SMS Medical College Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M368||Systemic disorders of connective tissue in other diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Colchicine  Colchicine in the dose of 0.5mg twice daily added on to existing stable conventional therapy which the patient was continuing during 1 month prior to the randomisation.  
Comparator Agent  Existing stable conventional therapy (standard of care)   Standard of care which is as follows: The conventional therapy including one conventional/ biologic or targeted synthetic disease modifying antirheumatic drugs (DMARD) which the patient was receiving for last 1month will be continued at the same dose. The DMARD permitted would be either of the following: Once weekly methotrexate or mycophenolate or azathioprine or tofacitinib or adalimumab or tocilizumab.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.TAK with persistent systemic inflammation defined as having least 2 consecutive values of CRP more than or equal to 10mg per litre over a minimum of 6 months, without any alternative explanation of raised inflammatory markers
2.On stable immunosuppressants with steroids less than 7.5mg per day during at least 1 month prior to enrolment.
3.Age between 18 to 60 years of age
4.Mild or no clinical activity as defined by Indian Takayasu arteritis 2010 score ie ITAS more than or equal to 2 and ITAS score of 0 respectively.
5.Have signed the written informed consent.
 
 
ExclusionCriteria 
Details  1.Diastolic blood pressure above 90mm Hg in upper limbs or above 100mm Hg in lower limbs despite 3 antihypertensives.
2.Serum creatinine of more than 1.7mg / dl or eGFR of less than 50 ml/min/ 1.73m2.
3.Presence of heart failure or left ventricular ejection fraction of less than 45%.
4.Symptoms of peripheral neuritis, myositis, marked myo-sensitivity to statins.
5.Requiring planned vascular intervention in the next 24 months.
6.Ischemic stroke in the preceding 3 months
7.Presence of severe Aortic regurgitation.
8.Presence of inflammatory bowel disease or severe abdominal pain.
9.Pregnancy or planning pregnancy or breast feeding during next 12 months.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The percentage of participants who attain complete remission at 24 weeks defined as by attainment of ITAS score of 0 with CRP less than 10mg per litre AND stable angiogram with steroid dose less than or equal to 2.5mg per day at 24 weeks.   24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 

1. Percentage of patients who are in clinical remission as defined by ITAS equal to 0 with steroid dose of less than or equal to 2.5mg per day at 24 weeks.
2. Percentage of patients who are in laboratory remission at 6 months with steroid dose of less than or equal to 2.5mg per day at 24 weeks.
3. Percentage of patients who have stable angiograms at 6 months with steroid dose of less than or equal to 2.5mg per day at 24 weeks.
4. The percentage of patients with adverse drug reactions with colchicine as compared with conventional medical therapy for 24 weeks.
5. To assess and compare serum bio markers of inflammation and whole blood transcriptomics before and after 24 weeks of therapy between colchicine arm and standard of care.
 		 24 weeks  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/02/2025 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Objectives: The primary objective is to study the efficacy of 24 weeks of add on colchicine as compared with conventional therapy in TAK with persistent systemic inflammation.

Secondary objective is i) To assess and compare changes in serum biomarkers and whole-blood-transcriptomics before and after 24 weeks of therapy with the trial drugs.

Methods: Patients with TAK with persistently raised CRP>10mg/L, with ITAS<2 (Figure-2) would be recruited from multiple tertiary-care centres and randomly assigned (1:1) to receive either add-on-colchicine or conventional therapy. All patients would undergo 3-monthly clinical and CRP assessment and angiogram, biomarker profiling by multiplex-ELISA and RNA sequencing at 24 weeks. RNA-sequencing will be also performed for TAK patients with normal CRP as disease controls.   Primary outcome is defined as percentage of patients achieving complete remission at 24 weeks with steroids≤2.5mg/day. Serum biomarker concentration and expression of selected genes which are differentially gene expressed between trial patients  will be compared before and after 24 weeks of therapy with study drugs. 

Expected outcomes: Colchicine may be better than conventional therapy as add-on agent in inducing remission, reverting molecular aberrations in TAK with persistent systemic inflammation. The specific molecular pathways driving the effect of colchicine on persistent systemic inflammation in TAK will be identified.

 
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