Gradual Withdrawal of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus.

Last updated: April 17, 2024
Sponsor: Phramongkutklao College of Medicine and Hospital
Overall Status: Completed

Phase

N/A

Condition

Systemic Lupus Erythematosus

Lupus

Cutaneous Lupus Erythematosus

Treatment

Glucocorticoid withdrawal group

Glucocorticoid maintenance group

Clinical Study ID

NCT06234852
LUCRA001
  • Ages > 20
  • All Genders

Study Summary

This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged; 20 years
  • Diagnosis of SLE according to Systemic Lupus International Collaborating Clinic (SLICC) classification SLE criteria, 2012.
  • Achieved clinically quiescent SLE defined as cSLEDAI-2K = 0 for at least 6 months.
  • Current treatment regimen including prednisolone 5mg/day. Prednisolone, antimalarialsand/or immunosuppressive therapy had to be stable for at least 4 weeks beforerandomization.

Exclusion

Exclusion Criteria:

  • Pregnant or pregnancy planning
  • Unable to follow the schedules
  • Overlap with other autoimmune disease, except secondary SjS and APS
  • Co-morbid with any other condition which required prednisolone treatment
  • Documented adrenal insufficiency

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Glucocorticoid withdrawal group
Phase:
Study Start date:
January 24, 2023
Estimated Completion Date:
April 17, 2024

Study Description

Glucocorticoids (GCs) remains the mainstay of treatment in SLE. Prolong used of glucocorticoid can be leading to various organ damage, even in low dose (< 7.5 mg/day). The rational of tapering GCs in SLE who achieve remission or low disease activity is still debated. Recent trial showed the abrupt discontinuation of GCs in sustained clinical remission of SLE increased rate of flare. This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone over 24 weeks in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.

Connect with a study center

  • Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine

    Bangkok, 10400
    Thailand

    Site Not Available

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