Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iguratimod, low-dose rituximab.
- Who it may be relevant to
- Registry conditions: Immune Thrombocytopenia (ITP). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Drug Iguratimod
oral iguratimod at 25mg twice daily for 26 weeks - Drug low-dose rituximab
rituximab 100mg once weekly for 6 weeks
Primary outcome measures
- overall response [Time frame: From the start of study treatment (Day 1) up to the end of Year 1]
Secondary outcome measures (7)
- sustained response [Time frame: From the start of study treatment (Day 1) up to the end of Year 1]
- complete response [Time frame: From the start of study treatment (Day 1) up to the end of Year 1]
- time to response [Time frame: From the start of study treatment (Day 1) up to the end of Year 1]
- duration of response [Time frame: From the start of study treatment (Day 1) up to the end of Year 1]
- incidence of adverse events [Time frame: All patients were assessed for adverse events every week during the first 4 weeks of treatment, and at 2-weeks interval for the following 5 months, and monthly thereafter. Adverse events were scaled according to CTCAE 5.0]
- Bleeding events [Time frame: From the start of study treatment (Day 1) up to the end of Year 1]
- Health-related quality of life (HRQoL) [Time frame: From the start of study treatment (Day 1) up to the end of Year 1]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Insititute of Hematology — Beijing
Identifiers
NCT: NCT07057778 · Pku-IGU-ITP-03