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A clinical study on drug reduction and withdrawal initiated by investigators in the treatment of SLE patients with belyumumab for injection

A clinical study on drug reduction and withdrawal initiated by investigators in the treatment of SLE patients with belyumumab for injection

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052342
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic lupus erythematosus

Interventions

Belimumab + standard therapy group 1:Belimumab(5mg/kg.m)+ standard therapy
Belimumab + standard therapy group 2:Belimumab(10mg/kg.m)+standard therapy
Belimumab + standard of care group 3:Belimumab(10mg/kg.2m)+standard of care group

Sponsors

Affiliated Hospital of Guilin Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Those who voluntarily sign the informed consent form, are able to comply with the plan and have the ability to carry out relevant procedures; 2. Age 16 to 65 years old, both men and women, the gender ratio is not limited; 3. Patients diagnosed with active SLE who have used belimumab for 1 course and achieved SRI-4 response. (At least 4 of the 11 criteria for SLE revised by the American College of Rheumatology in 1997 were met at the time of diagnosis)

Exclusion criteria

Exclusion criteria: Due to other circumstances, the investigator believes that it is not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
The time of the first flare;

Secondary

MeasureTime frame
Lupus Comprehensive Evaluation Index BICLA Score;Adverse events;Lupus Comprehensive Evaluation Index SRI-4 Score;

Countries

China

Contacts

Public ContactMo Hanyou

Affiliated Hospital of Guilin Medical College

mohanyou@hotmail.com+86 18007730655

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026