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

Phase 4

Recruiting

• Conditions: Systemic lupus erythematosus withorgan or system involvement,

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

Brief Summary

This study is a randomized, open label, parallel group, single centre trial comparing the efficacy of Inj Methylprednisolone 125mg OD and Inj Dexamethasone 8mg BD daily for 3 days in 100 patients(50 in each group) with SLE having moderate or severe disease activity. SLEDAI-2K and SLEDAI-2KG score will be calculated at baseline. Following the intervention, all the patients will receive standard of care as per the British Society of Rheumatology(BSR) Guidelines(2018).The primary outcome measure will be achievement of SRI-50 improvement definitons in the relevant parameters of SLEDAI 2k score at baseline and day 60 in the two groups. The secondary outcomes will be SLEDAI 2KG score at  day 60.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-15
• Last Update Posted: 2025-01-19

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

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.
• 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 .	day 15 30 & 60 post intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St Johns Medical College Hospital; 🇮🇳 Bangalore, KARNATAKA, India

St Johns Medical College Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Anirudh Maslekar

Principal investigator

9880670806

anirudh.maslekar@gmail.com