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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT04127747
Phase
PHASE4
Status
Unknown

Conditions

  • Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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).

Study Details

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.

Key Dates

Start date
Aug 18, 2020
Status verified
Sep 2020
Primary completion
Dec 31, 2022
Completion
Jul 1, 2023

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard dose group
  • Experimental: Individualized dose group

Primary Outcome Measure

Disease recurrence rate within 24 months. [ Time Frame: 24 months ]

Central Contacts

Related Studies