Health Condition 1: M329- Systemic lupus erythematosus, unspecified
Conditions
Interventions
Intervention1: Glucocorticoid tapering and withdrawal: participants will enter the trial on prednisolone less than or equal to 7.5mg/day. Gradual tapering of the drug will be done over a period of thr
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: i. Patients classified as Systemic Lupus Erythematosus(SLE) according to Systemic Lupus International Collaborating Clinic criteria for the classification of SLE (SLICC criteria). ii. Age 18 years or above iii. At least 3 years of total treatment and 1 year of complete remission before withdrawing treatment and on stable dose of prednisolone/immunosuppressant. Remission of SLE defined as per DORIS consensus (Remission on therapy allows patients to be treated with maintenance antimalarial, stable, low-dose glucocorticoids, maintenance immunosuppressants and/or stable (maintenance) biologics
Exclusion criteria
Exclusion criteria: i. Pregnancy or women in the reproductive age group who have not yet completed family and not willing for contraception as required. ii. Patients with estimated Glomerular Filtration Rate (eGFR) iii. Renal biopsy at remission showing histological activity score >4/24 or presence of crescents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of patients experiencing a flareTimepoint: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between changes in serological markers (anti-dsDNA antibodies Serum complements C3 and C4 levels, Serum Blymphocyte stimulator (BLys) levels and anti C1q antibody levels) and and outcome at 52 weeksTimepoint: 52 weeks;Correlation of baseline renal biopsy findings and outcome at 52 weeks among those participants with a past history of proliferative lupus nephritisTimepoint: 52 weeks;Proportion of patients experiencing an increase in the Systemic Lupus International Collaborating Clinics (SLICC) damage index (SDI) between randomisation and week 52.Timepoint: 52 weeks;Time to flareTimepoint: 52 weeks | — |
Countries
India
Contacts
Public ContactAishwarya G
JIPMER
Outcome results
None listed