A clinical trial to study the effects of two drugs,Methylprednisolone and Dexamethasone in patients with Systemic Lupus Erythematosus

Phase 4

• Conditions: Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement

• Registration Number: CTRI/2023/11/059463
• Lead Sponsor: Dr Anirudh Maslekar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement of SLEDAI-2K Responder Index-50 (SRI-50) improvement definition in the relevant parameters of SLEDAI-2K score between the two groups . <br/ ><br>Timepoint: day 15 30 & 60 post intervention

Secondary Outcome Measures

Name	Time	Method
SLEDAI-2KG ScoreTimepoint: day 15 30 & 60