Health Condition 1: M329- Systemic lupus erythematosus, unspecified
Conditions
Interventions
Intervention1: Withdrawal of Immunosuppresant: Patients will be withdrawn off the immunosuppressant agent (other than glucocorticoid)they are taking (Eg. Mycophenolate/ Methotrexate)
Control Intervent
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: In Low Lupus Disease activity state for at least 1 year Received immunosuppression for at least 3 years with stable dose for the last 6 months. No BILAG A manifestation in any organ (except constitutional) in the last 3 years. Patients on both an immunosuppressant and glucocorticoid Not on more than one immunosuppressant at the time of enrolment Not received any biologics for the last 1 year prior to enrolment Not more than 50% increase for not more than 2 weeks in dose of glucocorticoid/immunosuppression on not more than two occasions over the last 1 year Compliance with stable long-term hydroxycholorquine use
Exclusion criteria
Exclusion criteria: Patients with overlap syndrome Patients who have had renal involvement (proven by renal biopsy)anytime. Any documented suspicion of Lupus nephritis, as defined by: Two values of 24 h urine protein greater than 500mg/day Physician opinion that the patient ever had lupus nephritis Pregnancy or planning pregnancy Contraindication to hydroxycholoroquine use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the proportion of flares (as defined by an increase in SLE Flare Index by greater than or equal to 4) from the point of complete immunosuppressant or glucocorticoid withdrawal to week 24, in patients of non renal SLE, on immunosuppressive therapy for at least 3 years and in Low Lupus Disease Activity State (LLDAS) for 1 yearTimepoint: 6 months after complete withdrawal | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the proportion of severe flares (as defined by SELENA-SLEDAI Flare Index greater than or equal to 12) between immunosuppression withdrawal and glucocorticoid withdrawal strategies in patients In patients of non renal SLE immunosuppressive therapy for at least 3 years and in LLDAS for 1 year. Timepoint: 6 months after complete withdrawal;To determine the proportion of flares, as defined by the EASY-BILAG scoreTimepoint: 6 months after complete withdrawal;To identify the differences in serological activity (anti-dsDNA antibody, C3, and C4 levels) over time in both groups.Timepoint: Baseline and 6 months after complete withdrawal;To identify baseline predictors associated with time to first disease flare following treatment withdrawal.Timepoint: 6 months after complete withdrawal | — |
Countries
India
Contacts
Public ContactSudharshan J
Nizams Institute of Medical Sciences
Outcome results
None listed