Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus Erythematosus

NCT ID: NCT04127747

Last Updated: 2020-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-18
• Study Completion Date: 2023-07-01

Brief Summary

Several clinical studies have shown that rituximab is safe and effective for the induction of remission in moderate to severe systemic lupus erythematosus, and has been recommended by several guidelines for the induction of remission in refractory lupus with important organ involvement. However, there are few studies on the use of rituximab in the long-term maintenance and remission of the disease. There is no recognized scheme for the dose, interval and course of treatment of the drug. In this study, patients with moderate and severe systemic lupus erythematosus who achieved remission after standardized treatment were randomly divided into two groups at 1:1 and followed up every 3 months for 24 months. The basic situation and disease activity score of each subject were recorded. The recurrence rate of each observation group was calculated, the influencing factors of disease recurrence were analyzed, and a more reasonable drug use scheme was explored.

Conditions

Autoimmune Diseases

Keywords

Systemic lupus erythematosus; rituximab

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard dose group

Group Type: ACTIVE_COMPARATOR

Standard dose of rituximab

Intervention Type: DRUG

Patients in this group will accept RTX 500mg treatment on the first day and on the 6th, 12th,18th and 24th month after that.

Individualized dose group

Group Type: EXPERIMENTAL

Individualized dose of rituximab

Intervention Type: DRUG

Patients in this group will accept RTX 500mg treatment on the first day of admission. Patients will be followed-up every 3 months, and will receive one RTX 500mg treatment, if CD19 B cell count ≥ 1%, or dsDNA titer increased (dsDNA antibody positive, and increased more than 100% compared with the previous time), or complement C3 level decreased (lower than normal value, and decreased more than 50% compared with the previous time).

Interventions

Standard dose of rituximab

Patients in this group will accept RTX 500mg treatment on the first day and on the 6th, 12th,18th and 24th month after that.

Intervention Type: DRUG

Individualized dose of rituximab

Patients in this group will accept RTX 500mg treatment on the first day of admission. Patients will be followed-up every 3 months, and will receive one RTX 500mg treatment, if CD19 B cell count ≥ 1%, or dsDNA titer increased (dsDNA antibody positive, and increased more than 100% compared with the previous time), or complement C3 level decreased (lower than normal value, and decreased more than 50% compared with the previous time).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age, 18-65 years old, weight ≥ 40 kg, sex unlimited.

2. Clearly diagnosed with systemic lupus erythematosus.

3. There was at least one BILAG B or above score in the kidney, blood system and nervous system.

4. After standardized treatment with high dose glucocorticoid combined with immunosuppressants such as CTX,MMF or RTX, complete or partial remission of the disease was achieved (up to 1 BILAG B score, and at least 1 BILAG A or BILAG B score less than before).

5. Glucocorticoid: prednisone or the equivalent of prednisone less than or equal to 20 mg daily dose, and can be increased or decreased within 20 mg during the study.

6. Subjects are willing to participate in this study and sign informed consent voluntarily.

7. Prospective subjects agreed to use effective contraception throughout the study period.

Exclusion Criteria

1. Abnormal liver function: ALT or AST >2ULN，or ALP or TBil >1.5ULN

2. Severe cardiopulmonary disease;

3. Severe blood system disease

4. Patient with malignant tumor;

5. Concurrent infection：Subjects were hospitalized for infection or treated with parenteral antibiotics within 30 days before random; Hepatitis B surface antigen positive or active hepatitis, not treated with hepatitis B antivirus; T-SPOT positive or active tuberculosis, not treated with antituberculous therapy; Any positive in HCV-Ab, HIV-Ab, or TPPA ;

6. Pregnant patients or patients with recent fertility requirements;

7. Received cyclophosphamide treatment within 30 days before random;

8. For any other reason, the investigator believes that it is inappropriate to participate in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fei Han

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Zhichun Liu

Role: PRINCIPAL_INVESTIGATOR

The second affiliated hospital of Suzhou University, school of medicine

Wenfeng Tan

Role: PRINCIPAL_INVESTIGATOR

The people's hospital of Jiangsu province

Xiudi Wu

Role: PRINCIPAL_INVESTIGATOR

The first hospital of Ningbo

Hongzhi Wang

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Jiaxing University

Hongwei Du

Role: PRINCIPAL_INVESTIGATOR

Jinhua Central Hospital

Yongmei Han

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Locations

Second affiliated hospital of zhejiang university，school of medical

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Xue

Role: CONTACT

Phone: 13858121751

Email: jingxue@zju.edu.cn

Facility Contacts

Jing Xue

Role: primary

Other Identifiers

2019-233

Identifier Type: -

Identifier Source: org_study_id