Optimization of Glucocorticoid Taper Strategies for SLE-ITP

August 22, 2022 updated by: Fujian Medical University Union Hospital

Optimization of Glucocorticoid Taper Strategies for Maintenance Therapy of Systemic Lupus Erythematosus Associated Immune Thrombocytopenia (SLE-ITP)

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

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

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital

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

14 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. -

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard GCs taper group
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.
Experimental: rapid GCs taper group
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.
Procedure: rapid GCs taper
After a complete response was achieved, the GCs dose was halved from the original dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
significant relapse
Time Frame: within 12 weeks
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.
within 12 weeks
significant relapse
Time Frame: within 24 weeks
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.
within 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mild to moderate relapse
Time Frame: within 12 weeks
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.
within 12 weeks
Mild to moderate relapse
Time Frame: within 24 weeks
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.
within 24 weeks
Clinical remission
Time Frame: at 24 weeks
According to DORIS's definition of SLE remission in 2021.
at 24 weeks
a Lupus Low Disease Activity State
Time Frame: at 24 weeks
According to the definition of SLE low disease activity state formulated in 2015.
at 24 weeks

Collaborators and Investigators

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

Sponsor

Fujian Medical University Union Hospital

Investigators

  • Principal Investigator: He-Jun Li, MD, Fujian Medical University Union Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 15, 2022

Primary Completion (Anticipated)

August 20, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tanklhj@163.com

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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