Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified Health Condition 2: M329- Systemic lupus erythematosus, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Maulana Azad Medical College and Lok Nayak Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed SLE and RA patients who are on Hydroxychloroquine and have good compliance with the drug Patients who are on stable, continuous dose of 400mg of Hydroxychloroquine Once a day for at least 6 months
Exclusion criteria
Exclusion criteria: Abnormal liver function tests due to diagnosed chronic liver disease due to any cause, chronic alcoholic, hepatitis B or C, Liver transaminases and or ALP persistently more than 2 times Upper Limit of Normal Haemoglobin less than 8 gm per dL Pregnancy Who are taking drugs that can interfere with Hydroxychloroquine metabolism Known HIV positive, Diabetes, hypothyroidism, Recent changes in body weight more than 10 percent gain or loss Any active infection or acute major organ dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentrations of Hydroxychloroquine in patients of SLE and RA and correlation of these levels with CYP3A1, 2A5,2C8 and 2D6 genetic mutationsTimepoint: Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of significant CYP3A4 & CYP2A5, 2C8, 2D6 polymorphisms in patients of RA & SLE Correlation of blood Hydroxychloroquine levels with clinical efficacy & toxicity among patients of SLE Comparison & validation of the method of measuring Hydroxychloroquine with spectrophotometer with that of LCMSHPLCTimepoint: Baseline | — |
Countries
India
Contacts
Public ContactManu Shetty
Maulana Azad Medical College
Outcome results
None listed