Systemic Lupus Erythematosus, SLE
Conditions
Keywords
Systemic Lupus Erythematosus, Glucocorticosteroid, Flare
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.
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.
Interventions
BEHAVIORALGlucocorticoid withdrawal group
Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks
BEHAVIORALGlucocorticoid maintenance group
Daily 5-mg prednisolone over 24 weeks
Sponsors
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any flare according any of 3 definitions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any increase in clinical SLEDAI-2K | 24 weeks | Percentage of participants with any increase in clinical SLEDAI-2K |
| Any changes in immunology | 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 |
| Any increase in damage accrual | 24 weeks | Percentage of participants with any increase in Systemic Lupus International Collaborating Clinic/American College of Rheumatology Damage Index (SDI) Score. |
| Changes in quality of life | 24 weeks | Changes in Score of Systemic Lupus Erythematosus Quality Of Life (SLEQoL) Questionnaire (mean difference) |
Countries
Thailand
Outcome results
None listed