Health Condition 1: M368- Systemic disorders of connective tissue in other diseases classified elsewhere
Conditions
Interventions
Intervention1: 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.
Cont
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactRuchika Goel
Christian Medical College, Vellore
Outcome results
None listed