Safety Study of Isoniazid and Pyridoxine to Prevent Tuberculosis in Women with Systemic Lupus Erythematosus Aged 18 to 55

What this Trial Is About

Systemic Lupus Erythematosus SLE is an autoimmune disease that affects multiple body systems with a wide range of symptoms, from mild skin and joint problems to severe, life-threatening issues. Patients with SLE are more vulnerable to infections due to their weakened immune system and the use of steroids and immunosuppressants. Tuberculosis TB is a common and serious infection in SLE patients, especially in Asia-Pacific countries, and there is currently no guideline for using isoniazid INH to prevent TB in these patients. This study compares two groups of SLE patients with mild or remission disease activity one group receives isoniazid 5 mgkgday up to 300 mgday plus pyridoxine 10 mgday for nine months, while the other group receives a placebo. Both groups continue their usual SLE medications. Patients are screened to exclude active TB, liver problems, pregnancy, malignancy, or history of allergy to INH. The study includes regular monitoring of liver enzymes and disease activity over one year. Participants will have their liver function and SLE activity checked at 2 weeks, monthly for the first three months, then every three months until one year. Researchers will assess drug-induced hepatitis and lupus disease activity using specific lab tests and clinical scores. The goal is to evaluate the safety of INH in preventing TB in SLE patients by carefully tracking side effects and disease changes during the study period.

Safety of Administering Isoniazid to SLE Patients to Prevent TB