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NCT06234852Completed

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

The Effect of Gradual Withdrawal Versus Maintenance of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Randomized Placebo Controlled Trial.

Source: ClinicalTrials.gov · Last updated 19 Apr 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
20 (actual)
First submitted
14 Jan 2024
Start date
24 Jan 2023
Primary completion date
26 Dec 2023
Lead sponsor
Phramongkutklao College of Medicine and Hospital
Diseases
Lupus (SLE)
NCT number
NCT06234852

What you commit to

  • Study type: Interventional
  • Participants enrolled: 20
  • From 24 Jan 2023 to the primary completion date, 26 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Overlap with other autoimmune disease, except secondary SjS and APS
  • Co-morbid with any other condition which required prednisolone treatment
  • Documented adrenal insufficiency

Other

  • Pregnant or pregnancy planning
  • Unable to follow the schedules

Who the study is looking for

  • 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, antimalarials and/or immunosuppressive therapy had to be stable for at least 4 weeks before randomization.

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine
Coordinator of this site? Confirm its status
BangkokThailandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.