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

Primary Purpose

Autoimmune Diseases

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Standard dose of rituximab

Individualized dose of rituximab

About this trial

This is an interventional treatment trial for Autoimmune Diseases focused on measuring Systemic lupus erythematosus, rituximab

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age, 18-65 years old, weight ≥ 40 kg, sex unlimited.
Clearly diagnosed with systemic lupus erythematosus.
There was at least one BILAG B or above score in the kidney, blood system and nervous system.
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).
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.
Subjects are willing to participate in this study and sign informed consent voluntarily.
Prospective subjects agreed to use effective contraception throughout the study period.

Exclusion Criteria:

Abnormal liver function: ALT or AST >2ULN，or ALP or TBil >1.5ULN
Severe cardiopulmonary disease;
Severe blood system disease
Patient with malignant tumor;
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 ;
Pregnant patients or patients with recent fertility requirements;
Received cyclophosphamide treatment within 30 days before random;
For any other reason, the investigator believes that it is inappropriate to participate in the trial.

Sites / Locations

Second affiliated hospital of zhejiang university，school of medicalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard dose group

Individualized dose group

Arm Description

Outcomes

Primary Outcome Measures

Disease recurrence rate within 24 months.

Evaluate the efficacy of individualized and standard dose rituximab in maintaining remission in moderate to severe SLE patients

Secondary Outcome Measures

Times of use of rituximab in 2 years

Full Information

NCT ID

NCT04127747

First Posted

October 14, 2019

Last Updated

November 15, 2020

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04127747

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 18, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Diseases

Keywords

Systemic lupus erythematosus, rituximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard dose group

Arm Type

Active Comparator

Arm Title

Individualized dose group

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Standard dose of rituximab

Intervention Description

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

Intervention Name(s)

Individualized dose of rituximab

Intervention Description

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).

Primary Outcome Measure Information:

Title

Disease recurrence rate within 24 months.

Description

Evaluate the efficacy of individualized and standard dose rituximab in maintaining remission in moderate to severe SLE patients

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Times of use of rituximab in 2 years

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age, 18-65 years old, weight ≥ 40 kg, sex unlimited. Clearly diagnosed with systemic lupus erythematosus. There was at least one BILAG B or above score in the kidney, blood system and nervous system. 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). 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. Subjects are willing to participate in this study and sign informed consent voluntarily. Prospective subjects agreed to use effective contraception throughout the study period. Exclusion Criteria: Abnormal liver function: ALT or AST >2ULN，or ALP or TBil >1.5ULN Severe cardiopulmonary disease; Severe blood system disease Patient with malignant tumor; 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 ; Pregnant patients or patients with recent fertility requirements; Received cyclophosphamide treatment within 30 days before random; For any other reason, the investigator believes that it is inappropriate to participate in the trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jing Xue

Phone

13858121751

jingxue@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fei Han

Organizational Affiliation

Zhejiang University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zhichun Liu

Organizational Affiliation

The second affiliated hospital of Suzhou University, school of medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wenfeng Tan

Organizational Affiliation

The people's hospital of Jiangsu province

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiudi Wu

Organizational Affiliation

The first hospital of Ningbo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hongzhi Wang

Organizational Affiliation

Affiliated Hospital of Jiaxing University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hongwei Du

Organizational Affiliation

Jinhua Central Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yongmei Han

Organizational Affiliation

Sir Run Run Shaw Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Second affiliated hospital of zhejiang university，school of medical

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jing Xue

Phone

13858121751

jingxue@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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