NCT06234852

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

January 14, 2024

Last Update Submit

April 17, 2024

Conditions

Systemic Lupus Erythematosus, SLE

Keywords

Systemic Lupus ErythematosusGlucocorticosteroidFlare

Outcome Measures

Primary Outcomes (1)

  • Any flare according any of 3 definitions

    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 Outcomes (4)

  • Any increase in clinical SLEDAI-2K

    24 weeks

  • Any changes in immunology

    24 weeks

  • Any increase in damage accrual

    24 weeks

  • Changes in quality of life

    24 weeks

Study Arms (2)

Glucocorticoid maintenance group

ACTIVE COMPARATOR

Maintenance of 5-mg of prednisolone daily over 24 weeks

Behavioral: Glucocorticoid maintenance group

Glucocorticoid withdrawal group

PLACEBO COMPARATOR

Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks

Behavioral: Glucocorticoid withdrawal group

Interventions

Glucocorticoid withdrawal groupBEHAVIORAL

Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks

Glucocorticoid withdrawal group
Glucocorticoid maintenance groupBEHAVIORAL

Daily 5-mg prednisolone over 24 weeks

Glucocorticoid maintenance group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bangkok, 10400, Thailand

Location

Related Publications (1)

  • Niyompanichakarn S, Chaiamnuay S, Narongroeknawin P, Asavatanabodee P, Leosuthamas P, Pakchotanon R. The Effect of Gradual Withdrawal Versus Maintenance of Low-Dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Double-Blind Randomised Controlled Trial. Musculoskeletal Care. 2025 Jun;23(2):e70083. doi: 10.1002/msc.70083.

    PMID: 40148251DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Rattapol Pakchotanon, M.D.

    Phramongkutklao College of Medicine and Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2024

First Posted

January 31, 2024

Study Start

January 24, 2023

Primary Completion

December 26, 2023

Study Completion

April 17, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
Mid 2025
Access Criteria
IPD Sharing Access Criteria has not been decided.

Locations

TH(1)