Clinical trial NCT05506033: Optimization of Glucocorticoid Taper Strategies for SLE-ITP
Official title: Optimization of Glucocorticoid Taper Strategies for Maintenance Therapy of Systemic Lupus Erythematosus Associated Immune Thrombocytopenia (SLE-ITP)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lupus Erythematosus, Systemic
Purpura, Thrombocytopenic, Idiopathic
Glucocorticoids
Adverse Effect of Glucocorticoids
Keywords: GCs taper strategy
Lupus Erythematosus, Systemic
Purpura, Thrombocytopenic, Idiopathic
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SLE associated immune thrombocytopenia (SLE-ITP) is one of the main clinical manifestations of SLE. Approximately 70% of SLE patients follow a relapsing-remitting course. Similarly, SLE-ITP often relapses during GCs tapering. At the same time, patients with SLE-ITP may suffer from thrombocytopenia and damage to vital organs when they relapse, seriously affecting their lives. Therefore, maintenance therapy after remission is an inevitable choice for SLE-ITP.

The SLE guidelines recommend GCs and immunosuppressive agents(ISA) are first-line maintenance treatment in the treatment of SLE-ITP. GCs is indispensable in SLE treatment, but it is associated with a series of side effects, which are related to the dosage and duration of use. How to maintain remission with the most appropriate dose of GCs is a problem that needs to be considered in clinical practice. However, the existing guidelines lack detailed recommendations on the specific use of GCs in maintenance therapy for SLE-ITP, and there is also a lack of relevant clinical studies to guide. The GCs reduction regimen commonly used in maintenance therapy is a gradual reduction after 1 month of adequate GCs therapy, usually by 10% of the original dose every 2 weeks. However, the side effects of this reduction method are obvious, and whether the treatment can be maintained with less cumulative dose and maintenance duration of GCs is an urgent problem to be solved.

Clinical observations show that in a small number of patients with relative contraindications to GCs, a more rapid taper can maintain an effective response. Currently, rapid dosing reduction is recommended in both Lupus nephritis(LN) and the ANCA-associated nephritis guidelines of ACR. However, SLE-ITP changes more rapidly than LN. Although similar maintenance responses have been observed in a few patients between rapid dosing reduction and conventional method, relevant clinical studies are lacking. It is necessary to explore the effectiveness of rapid GCs tapering method.

Therefore, the investigators plan to conduct a single-center, prospective, randomized design, non-blind, non-inferiority controlled study on the optimization of GCs taper strategy for SLE-ITP maintenance therapy.In this study,sustained response rate and relapse rate within 3 months and 6 months were observed to judge the effectiveness of rapid GCs taper strategy, thus providing a basis for clinical GCs taper strategy.

Detailed description: Complete response was defined as a platelet count ≥100x10\^9/L and the absence of bleeding and new other symptoms.Complete response would be confirmed by platelet counts on 2 separate occasions 7 days apart. Adequate glucocorticoids treatment was defined as at least a dose 50mg/day of prednisone (or equivalent glucocorticoids) for patients with weight less than 50kg, 60mg/day for patients with weight 50-75kg , 75mg/day for patients with weight more than 75kg. Adequate glucocorticoids were used for induction, and the total duration of adequate glucocorticoids treatment for patients enrolled was no longer than 3 weeks.Neither Thrombopoietin receptor agonist(TPO-RA) nor intravenous immunoglobulin(IVIG)were permitted in induction therapy or maintenance therapy.In addition to hydroxychloroquine(HCQ), other immunosuppressive agents are not permitted in induction therapy or maintenance therapy. After confirmation of complete response, the patients enrolled were randomly divided into two groups according to two different methods of GCs taper.

Eligibility criteria: Inclusion Criteria:

1. Men and women aged 14-75 (including 14 and 75);
2. It meets the 2012 Systemic lupus Erythematosus International Collaborative Group (SLICC) classification criteria or the 2019 ACR and European Society of Rheumatology (EULAR) classification criteria ;
3. severe SLE-ITP patients with PLT≤30x10\^9/L at onset and complete response (PLT ≥100x10\^9/L) after induction therapy within 3 weeks;
4. Prior to the commencement of any study-specific procedure, the patient or legal representative must provide signed and dated written informed consent.

Exclusion Criteria:

1. Relapse in the presence of glucocorticoid and/or immunosuppressive maintenance therapy;
2. Combined with antiphospholipid syndrome;
3. Combined with other important organ damage such as lupus nephritis, neuropsychiatric lupus;
4. Coexisting immune diseases require glucocorticoid and/or immunosuppressive therapy;
5. There are serious comorbidities affecting treatment such as diabetes, severe hypertension, coronary heart disease;
6. self-evaluation affected by poor understanding ability, vision decline and other reasons ;
7. Poor adherence and failure to adhere to treatment as prescribed. -

Primary outcomes:
measure: significant relapse
timeFrame: within 12 weeks
measure: significant relapse
timeFrame: within 24 weeks
Secondary outcomes:
measure: Mild to moderate relapse
timeFrame: within 12 weeks
measure: Mild to moderate relapse
timeFrame: within 24 weeks
measure: Clinical remission
timeFrame: at 24 weeks
measure: a Lupus Low Disease Activity State
timeFrame: at 24 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: He-Jun Li, MD
role: PRINCIPAL_INVESTIGATOR
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