A clinical trial to study the effect of stopping medicine in Systemic Lupus Erythematosus patients with well controlled disease
- Conditions
- Health Condition 1: M329- Systemic lupus erythematosus, unspecified
- Registration Number
- CTRI/2020/07/026712
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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) < 60ml/min/m2
iii.Renal biopsy at remission showing histological activity score >4/24 or presence of crescents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of patients experiencing a flareTimepoint: 52 weeks
- Secondary Outcome Measures
Name Time Method 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