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

NCT04127747 | Unknown Phase 4

• 1 other identifier: 2019-233
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Times of use of rituximab in 2 years

  24 months

Study Arms (2)

Standard dose group

ACTIVE COMPARATOR

Drug: Standard dose of rituximab

Individualized dose group

EXPERIMENTAL

Drug: Individualized dose of rituximab

Interventions

Standard dose of rituximab 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.

Standard dose group

Individualized dose of rituximab 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).

Individualized dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second affiliated hospital of zhejiang university，school of medical

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases; Lupus Erythematosus, Systemic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Immune System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• 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

  Affiliated Hospital of Jiaxing University

  PRINCIPAL INVESTIGATOR

• Hongwei Du

  Jinhua Central Hospital

  PRINCIPAL INVESTIGATOR

• Yongmei Han

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Xue

CONTACT

13858121751; jingxue@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: August 18, 2020
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: November 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)