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

April 17, 2024 updated by: Phramongkutklao College of Medicine and Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glucocorticoid maintenance group
Maintenance of 5-mg of prednisolone daily over 24 weeks
Behavioral: Glucocorticoid maintenance group
Daily 5-mg prednisolone over 24 weeks
Placebo Comparator: Glucocorticoid withdrawal group
Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks
Behavioral: Glucocorticoid withdrawal group
Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any flare according any of 3 definitions
Time Frame: 24 weeks
Flare definition: 1. Clinical SLEDAI 2K (excluding serology) ≥ 4, 2. Increase in SLE-DAS ≥ 1.72, 3. Increase in clinical SLEDAI-2K plus treatment escalation (including with NSAIDS, glucocorticoids (topical or oral), antimalarials, or immunosuppressants.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any increase in clinical SLEDAI-2K
Time Frame: 24 weeks
Percentage of participants with any increase in clinical SLEDAI-2K
24 weeks
Any changes in immunology
Time Frame: 24 weeks
Percentage of participants with the decrease of C3 or C4 by 50% and/or the increase of anti-dsDNA by 25% as compared with baseline
24 weeks
Any increase in damage accrual
Time Frame: 24 weeks
Percentage of participants with any increase in Systemic Lupus International Collaborating Clinic/American College of Rheumatology Damage Index (SDI) Score.
24 weeks
Changes in quality of life
Time Frame: 24 weeks
Changes in Score of Systemic Lupus Erythematosus Quality Of Life (SLEQoL) Questionnaire (mean difference)
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phramongkutklao College of Medicine and Hospital

Investigators

  • Study Director: Rattapol Pakchotanon, M.D., Phramongkutklao College of Medicine and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2023

Primary Completion (Actual)

December 26, 2023

Study Completion (Actual)

April 17, 2024

Study Registration Dates

First Submitted

January 14, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUCRA001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol is to be shared with others. Full data would become available by mid 2025.

IPD Sharing Time Frame

Mid 2025

IPD Sharing Access Criteria

IPD Sharing Access Criteria has not been decided.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Lupus Erythematosus, SLE

Clinical Trials on Glucocorticoid maintenance group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe