Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
Conditions
Interventions
Intervention1: Isoniazide 300mg+Rifapentine 300mg Fixed Dose Combination: 3 tablets taken once a week for 12 weeks
Control Intervention1: Placebo: 3 tablets taken once a week for 12 weeks
Sponsors
Department of Clinical Immunology and Rheumatology, SGPGI, Lucknow
ICMR New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. SLE as per ACR 2019 Classification Criteria 2. Age 18 years or above. 3. Disease flare with SLEDAI-2K of 8 or greater. 4. Anticipated to require prednisolone dose of 10 mg per day or greater for at least 1 month
Exclusion criteria
Exclusion criteria: Pregnant and Lactating females Diagnosed tuberculosis and SLE simultaneously EGFR less than 30 AST or ALT greater than 80 and attributable to liver disease Chronic Liver Disease with Child Pugh Class C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients developing incident tuberculosisTimepoint: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate ratio for TB in those with and without a positive interferon gamma release assay (IGRA) or PPD testTimepoint: 52 weeks;Proportion of patients in Lupus Low Disease Activity State (LLDAS) Timepoint: 52 weeks;SLICC Damage Index Timepoint: 52 weeks;Adverse eventsTimepoint: 52 weeks;MortalityTimepoint: 52 weeks | — |
Countries
India
Contacts
Public ContactRudrarpan Chatterjee
SGPGI Lucknow
Outcome results
None listed