Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
Conditions
Interventions
Intervention1: Low-dose oral glucocorticoids: Oral predinsolone will be started at 0.5mg/kg/day for 4 weeks and then tapered to reach 7.5mg/day by 15 weeks.
Control Intervention1: Standard-dose oral g
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Fulfilling the 2019 ACR/EULAR classification criteria for SLE. 2. Active SLE as indicated with SLEDAI-2K more than or equal to 1. 3. Any manifestation involving one or more major organs which will require an oral glucocorticoid dose of more than or equal to 0.5mg/kg/day for activity. 4. Ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Rapidly progressive renal failure requiring dialysis at presentation or with serum creatinine more than 4mg/dl at the time of randomization. 2. Lupus myocarditis with NYHA class III or IV heart failure at the time of presentation. 3. Severe diffuse alveolar hemorrhage with respiratory failure and requirement of mechanical ventilation at presentation. 4. Presence of active infection at the time of randomization. 5. Pregnant or lactating females. 6. Known contraindication or hypersensitivity to glucocorticoids. 7. Concomitant conditions precluding study participation in the investigator s judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of active SLE patients achieving Lupus Low Disease Activity State (LLDAS) at 24 weeks with standard-dose oral glucocorticoids versus low-dose oral glucocorticoids.Timepoint: Proportion of active SLE patients achieving Lupus Low Disease Activity State (LLDAS) at 24 weeks with standard-dose oral glucocorticoids versus low-dose oral glucocorticoids. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving DORIS-defined remission at 24 weeks with standard-dose oral glucocorticoids versus low-dose oral glucocorticoids.Timepoint: 24 weeks;Change in SLE Disease Activity Index-2000 (SLEDAI-2K) from baseline to 12 and 24 weeks between the two glucocorticoid groups.Timepoint: 12 and 24 weeks;Proportion of patients with lupus nephritis achieving renal response (complete or partial renal response) at week 24 between the two glucocorticoid groups.Timepoint: 24 weeks;Proportion of patients having glucocorticoid related adverse effects at week 24 between the two glucocorticoid groups.Timepoint: 24 weeks;Cumulative glucocorticoid dose at 24 weeks between the two groups.Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactGSRSNK Naidu
PGIMER, Chandigarh
Outcome results
None listed