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Optimization of Glucocorticoid Taper Strategies for SLE-ITP

Primary Purpose

Lupus Erythematosus, Systemic, Purpura, Thrombocytopenic, Idiopathic, Glucocorticoids

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rapid GCs taper
Sponsored by
Fujian Medical University Union Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring GCs taper strategy, Lupus Erythematosus, Systemic, Purpura, Thrombocytopenic, Idiopathic

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Fujian Medical University Union Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard GCs taper group

rapid GCs taper group

Arm Description

After a complete response (PLT ≥100x10^9/L) was confirmed, the dose of prednisone (or equivalent dose of glucocorticoids) would be reduced by 2 tablets every two weeks. When it reaches 6 tablets /d, the dose would be reduced by 1 tablet every 2 weeks, and when it reaches 15mg/d, the dose would be reduced by half tablet every 2 weeks.

After a complete response (PLT ≥100x10^9/L) was confirmed, the dose of prednisone (or equivalent dose of glucocorticoids) would be cut in half (25mg/d for weight less than 50kg, 30mg/d for weight 50-75kg , 40mg/d for weight more than 75kg ). After that, the dose would be reduced by 2 tablets every two weeks. When it reaches 6 tablets /d, the dose would be reduced by 1 tablet every 2 weeks, and when it reaches 15mg/d, the dose would be reduced by half tablet every 2 weeks.

Outcomes

Primary Outcome Measures

significant relapse
significant relapse were defined as 1 or more of the following: 1)a platelet count<30x10^9/L or less than 2-fold increase of the baseline platelet count or bleeding;2)new damage to important organs(renal, central nervous system, cardiopulmonary, vasculitis, myositis,fever, active hemolytic anemia or gastrointestinal activity);3)manifestations requiring an increase in prednisone(or equivalent) to >0.5mg/kg/day;4)SLEDAI-2K instrument score greater than 12;5) change in physician's global assessment score from baseline to greater than 2.5.
significant relapse
significant relapse were defined as 1 or more of the following: 1)a platelet count<30x10^9/L or less than 2-fold increase of the baseline platelet count or bleeding;2)new damage to important organs(renal, central nervous system, cardiopulmonary, vasculitis, myositis,fever, active hemolytic anemia or gastrointestinal activity);3)manifestations requiring an increase in prednisone(or equivalent) to >0.5mg/kg/day;4)SLEDAI-2K instrument score greater than 12;5) change in physician's global assessment score from baseline to greater than 2.5.

Secondary Outcome Measures

Mild to moderate relapse
Mild to moderate relapse were defined as 1 or more of the following: 1)30x10^9/L≤ a platelet count <100x10^9/L and at least 2-fold increase of the baseline count and absence of bleeding and new damage to important organs(renal, central nervous system, cardiopulmonary, vasculitis, fever, active hemolytic anemia or gastrointestinal activity);2)any manifestations requiring an increase in prednisone(or equivalent) not greater than 0.5mg/kg/day;3)greater than 3-point change in SLEDAI-2K instrument score, with total score of 12 or less;4)or change in the physician's global assessment score of 1.0 or more but remaining 2.5 or less.
Mild to moderate relapse
Mild to moderate relapse were defined as 1 or more of the following: 1)30x10^9/L≤ a platelet count <100x10^9/L and at least 2-fold increase of the baseline count and absence of bleeding and new damage to important organs(renal, central nervous system, cardiopulmonary, vasculitis, fever, active hemolytic anemia or gastrointestinal activity);2)any manifestations requiring an increase in prednisone(or equivalent) not greater than 0.5mg/kg/day;3)greater than 3-point change in SLEDAI-2K instrument score, with total score of 12 or less;4)or change in the physician's global assessment score of 1.0 or more but remaining 2.5 or less.
Clinical remission
According to DORIS's definition of SLE remission in 2021.
a Lupus Low Disease Activity State
According to the definition of SLE low disease activity state formulated in 2015.

Full Information

First Posted
August 16, 2022
Last Updated
August 22, 2022
Sponsor
Fujian Medical University Union Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05506033
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
August 20, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Medical University Union Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic, Purpura, Thrombocytopenic, Idiopathic, Glucocorticoids, Adverse Effect of Glucocorticoids
Keywords
GCs taper strategy, Lupus Erythematosus, Systemic, Purpura, Thrombocytopenic, Idiopathic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard GCs taper group
Arm Type
No Intervention
Arm Description
After a complete response (PLT ≥100x10^9/L) was confirmed, the dose of prednisone (or equivalent dose of glucocorticoids) would be reduced by 2 tablets every two weeks. When it reaches 6 tablets /d, the dose would be reduced by 1 tablet every 2 weeks, and when it reaches 15mg/d, the dose would be reduced by half tablet every 2 weeks.
Arm Title
rapid GCs taper group
Arm Type
Experimental
Arm Description
After a complete response (PLT ≥100x10^9/L) was confirmed, the dose of prednisone (or equivalent dose of glucocorticoids) would be cut in half (25mg/d for weight less than 50kg, 30mg/d for weight 50-75kg , 40mg/d for weight more than 75kg ). After that, the dose would be reduced by 2 tablets every two weeks. When it reaches 6 tablets /d, the dose would be reduced by 1 tablet every 2 weeks, and when it reaches 15mg/d, the dose would be reduced by half tablet every 2 weeks.
Intervention Type
Procedure
Intervention Name(s)
rapid GCs taper
Intervention Description
After a complete response was achieved, the GCs dose was halved from the original dose.
Primary Outcome Measure Information:
Title
significant relapse
Description
significant relapse were defined as 1 or more of the following: 1)a platelet count<30x10^9/L or less than 2-fold increase of the baseline platelet count or bleeding;2)new damage to important organs(renal, central nervous system, cardiopulmonary, vasculitis, myositis,fever, active hemolytic anemia or gastrointestinal activity);3)manifestations requiring an increase in prednisone(or equivalent) to >0.5mg/kg/day;4)SLEDAI-2K instrument score greater than 12;5) change in physician's global assessment score from baseline to greater than 2.5.
Time Frame
within 12 weeks
Title
significant relapse
Description
significant relapse were defined as 1 or more of the following: 1)a platelet count<30x10^9/L or less than 2-fold increase of the baseline platelet count or bleeding;2)new damage to important organs(renal, central nervous system, cardiopulmonary, vasculitis, myositis,fever, active hemolytic anemia or gastrointestinal activity);3)manifestations requiring an increase in prednisone(or equivalent) to >0.5mg/kg/day;4)SLEDAI-2K instrument score greater than 12;5) change in physician's global assessment score from baseline to greater than 2.5.
Time Frame
within 24 weeks
Secondary Outcome Measure Information:
Title
Mild to moderate relapse
Description
Mild to moderate relapse were defined as 1 or more of the following: 1)30x10^9/L≤ a platelet count <100x10^9/L and at least 2-fold increase of the baseline count and absence of bleeding and new damage to important organs(renal, central nervous system, cardiopulmonary, vasculitis, fever, active hemolytic anemia or gastrointestinal activity);2)any manifestations requiring an increase in prednisone(or equivalent) not greater than 0.5mg/kg/day;3)greater than 3-point change in SLEDAI-2K instrument score, with total score of 12 or less;4)or change in the physician's global assessment score of 1.0 or more but remaining 2.5 or less.
Time Frame
within 12 weeks
Title
Mild to moderate relapse
Description
Mild to moderate relapse were defined as 1 or more of the following: 1)30x10^9/L≤ a platelet count <100x10^9/L and at least 2-fold increase of the baseline count and absence of bleeding and new damage to important organs(renal, central nervous system, cardiopulmonary, vasculitis, fever, active hemolytic anemia or gastrointestinal activity);2)any manifestations requiring an increase in prednisone(or equivalent) not greater than 0.5mg/kg/day;3)greater than 3-point change in SLEDAI-2K instrument score, with total score of 12 or less;4)or change in the physician's global assessment score of 1.0 or more but remaining 2.5 or less.
Time Frame
within 24 weeks
Title
Clinical remission
Description
According to DORIS's definition of SLE remission in 2021.
Time Frame
at 24 weeks
Title
a Lupus Low Disease Activity State
Description
According to the definition of SLE low disease activity state formulated in 2015.
Time Frame
at 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged 14-75 (including 14 and 75); 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 ; severe SLE-ITP patients with PLT≤30x10^9/L at onset and complete response (PLT ≥100x10^9/L) after induction therapy within 3 weeks; Prior to the commencement of any study-specific procedure, the patient or legal representative must provide signed and dated written informed consent. Exclusion Criteria: Relapse in the presence of glucocorticoid and/or immunosuppressive maintenance therapy; Combined with antiphospholipid syndrome; Combined with other important organ damage such as lupus nephritis, neuropsychiatric lupus; Coexisting immune diseases require glucocorticoid and/or immunosuppressive therapy; There are serious comorbidities affecting treatment such as diabetes, severe hypertension, coronary heart disease; self-evaluation affected by poor understanding ability, vision decline and other reasons ; Poor adherence and failure to adhere to treatment as prescribed. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He-Jun Li, MD
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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30926722
Citation
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Results Reference
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Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. No abstract available.
Results Reference
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Results Reference
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Results Reference
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Jung JH, Soh MS, Ahn YH, Um YJ, Jung JY, Suh CH, Kim HA. Thrombocytopenia in Systemic Lupus Erythematosus: Clinical Manifestations, Treatment, and Prognosis in 230 Patients. Medicine (Baltimore). 2016 Feb;95(6):e2818. doi: 10.1097/MD.0000000000002818.
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Results Reference
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Optimization of Glucocorticoid Taper Strategies for SLE-ITP

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