Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-07-01

Brief Summary

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Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.

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Detailed Description

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Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of steroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Rituximab has been shown to partly improve the complete remission rate of ITP. The small molecule compound iguratimod is widely used as a novel antirheumatic drug to treat several autoimmune diseases. According to studies involving ITP mice, iguratimod may represent a new approach for the prevention and treatment of anti-platelet antibody-mediated ITP by modulating T-cell differentiation.

A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to the low-dose rituximab+iguratimod and the low-dose rituximab monotherapy groups. Platelet count, bleeding and other symptoms were evaluated before and after treatment.Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and iguratimod in patients with steroid-resistant/relapsed ITP.

Conditions

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Immune Thrombocytopenia (ITP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomly assigned at a 1:1 ratio to receive Iguratimod plus low-dose rituximab or high-dose rituximab alone. Each group requires 60 patients.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Iguratimod plus low-dose rituximab

Low-dose rituximab was used in combination with Iguratimod

Group Type EXPERIMENTAL

Iguratimod

Intervention Type DRUG

oral iguratimod at 25mg twice daily for 26 weeks

low-dose rituximab

Intervention Type DRUG

rituximab 100mg once weekly for 6 weeks

Low-dose rituximab

Low-dose rituximab alone

Group Type ACTIVE_COMPARATOR

low-dose rituximab

Intervention Type DRUG

rituximab 100mg once weekly for 6 weeks

Interventions

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Iguratimod

oral iguratimod at 25mg twice daily for 26 weeks

Intervention Type DRUG

low-dose rituximab

rituximab 100mg once weekly for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ITP confirmed by excluding other supervened causes of thrombocytopenia;
* Platelet count of less than 30×10\^9/L at enrollment;
* Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;

Exclusion Criteria

* Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus);
* Congestive heart failure;
* Severe arrhythmia;
* Nursing or pregnant women;
* Aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria;
* Creatinine or serum bilirubin levels each 1•5 times or more than the normal range;
* Active or previous malignancy;
* Patients with other diseases were undergoing treatment with immunosuppressants;
* Patients with ITP had received rituximab;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No