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

Methylprednisolone versus Dexamethasone in the treatment of Systemic Lupus Erythematosus with moderate or severe disease activity:A Randomised, Open Label Study. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059463
Enrollment
100
Registered
2023-11-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: INJ METHYLPREDNISOLONE: 250mg IV OD administered for 3 days Control Intervention1: INJ DEXAMETHASONE: 8mg IV BD administered for 3 days

Sponsors

Dr Anirudh Maslekar
Lead Sponsor

Eligibility

Inclusion 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

Exclusion criteria: 1.Age 2.Pregnancy 3.Hemodynamic instability and/or current ICU admission. 4.Diffuse alveolar haemorrhage. 5.Advanced renal disease –defined as eGFR 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

Design outcomes

Primary

MeasureTime frame
Achievement of SLEDAI-2K Responder Index-50 (SRI-50) improvement definition in the relevant parameters of SLEDAI-2K score between the two groups . Timepoint: day 15 30 & 60 post intervention

Secondary

MeasureTime frame
SLEDAI-2KG ScoreTimepoint: day 15 30 & 60

Countries

India

Contacts

Public ContactAnirudh Maslekar

St Johns Medical College

vineeta0204@gmail.com9845021146

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026