CTRI/2023/11/059463
Recruiting
Phase 4
Methylprednisolone versus Dexamethasone in the treatment of Systemic Lupus Erythematosus with moderate or severe disease activity:A Randomised, Open Label Study. - NI
Dr Anirudh Maslekar0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
- Sponsor
- Dr Anirudh Maslekar
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.All hospitalised patients of Systemic Lupus Erythematosus (SLE) who have previously met or currently meet the 2012 SLICC and/or 2019 ACR criteria for SLE.
- •2\.Moderate or severe disease activity as defined in The British Society for Rheumatology guideline for the management of systemic lupus erythematosus in adults (2018\) as :
- •a. Moderate disease activity\-SLEDAI\-2K score in the range of 6\-12\.
- •b. Severe disease activity\-SLEDAI\- 2K score of \>12
Exclusion Criteria
- •1\.Age \<18 years
- •2\.Pregnancy
- •3\.Hemodynamic instability and/or current ICU admission.
- •4\.Diffuse alveolar haemorrhage.
- •5\.Advanced renal disease –defined as eGFR \<15ml/min and/or RPRF
- •6\.Incomplete treatment records.
- •7\.Concurrent microbiologically documented infection.
- •8\.Any patient deemed to have a immediate increased risk of mortality as decided by the treating physician
Outcomes
Primary Outcomes
Not specified
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