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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04127747
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : November 17, 2020
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Autoimmune Diseases Drug: Standard dose of rituximab Drug: Individualized dose of rituximab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Rituximab

Arm Intervention/treatment
Active Comparator: Standard dose group 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.

Experimental: Individualized dose group 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).

Primary Outcome Measures :
  1. Disease recurrence rate within 24 months. [ Time Frame: 24 months ]
    Evaluate the efficacy of individualized and standard dose rituximab in maintaining remission in moderate to severe SLE patients

Secondary Outcome Measures :
  1. Times of use of rituximab in 2 years [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04127747

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Contact: Jing Xue 13858121751

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China, Zhejiang
Second affiliated hospital of zhejiang university,school of medical Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Jing Xue    13858121751   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
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Principal Investigator: Fei Han Zhejiang University
Principal Investigator: Zhichun Liu The second affiliated hospital of Suzhou University, school of medicine
Principal Investigator: Wenfeng Tan The people's hospital of Jiangsu province
Principal Investigator: Xiudi Wu The first hospital of Ningbo
Principal Investigator: Hongzhi Wang The First Hospital of Jiaxing
Principal Investigator: Hongwei Du Jinhua Central Hospital
Principal Investigator: Yongmei Han Sir Run Run Shaw Hospital
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University Identifier: NCT04127747    
Other Study ID Numbers: 2019-233
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
Systemic lupus erythematosus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents