Clinical trial NCT04127747: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Autoimmune Diseases
Keywords: Systemic lupus erythematosus
rituximab
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Disease recurrence rate within 24 months.
timeFrame: 24 months
Secondary outcomes:
measure: Times of use of rituximab in 2 years
timeFrame: 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated hospital of zhejiang university，school of medical
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Fei Han
role: PRINCIPAL_INVESTIGATOR
affiliation: The second affiliated hospital of Suzhou University, school of medicine
name: Zhichun Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: The people's hospital of Jiangsu province
name: Wenfeng Tan
role: PRINCIPAL_INVESTIGATOR
affiliation: The first hospital of Ningbo
name: Xiudi Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Jiaxing University
name: Hongzhi Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinhua Central Hospital
name: Hongwei Du
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Run Run Shaw Hospital
name: Yongmei Han
role: PRINCIPAL_INVESTIGATOR
References: