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

Autoimmune Diseases Clinical Trial

Official title:

A Multicenter, Randomized Controlled Clinical Study About Efficacy and Safety of Standard Dose and Individualized Dose of Rituximab in Maintaining Remission in Patients With Moderate to Severe Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127747
• Other study ID #: 2019-233
• Status: Recruiting
• Phase: Phase 4
• Start date: August 18, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jing Xue
• Phone: 13858121751
• Email: jingxue[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Lupus Erythematosus, Systemic

Intervention

Drug:
• 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.
• 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).

Locations

Country	Name	City	State
China	Second affiliated hospital of zhejiang university,school of medical	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease recurrence rate within 24 months.	Evaluate the efficacy of individualized and standard dose rituximab in maintaining remission in moderate to severe SLE patients	24 months
Secondary	Times of use of rituximab in 2 years		24 months