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Efficacy and safety of low-dose CTX combined with belimumab based on B/T cell balance in the treatment of moderate to severe systemic lupus erythematosus: a medical record-based study

Efficacy and safety of low-dose CTX combined with belimumab based on B/T cell balance in the treatment of moderate to severe systemic lupus erythematosus

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055471
Enrollment
Unknown
Registered
2022-01-10
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Systemic Lupus Erythematosus (SLE)

Interventions

belimumab group:Low-dose cyclophosphamide combined with belimumab
cyclophosphamide group:Standard dose cyclophosphamide

Sponsors

The Second Hospital of Shanxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. SLE patients admitted to the Second Hospital of Shanxi Medical University from January 2021 to June 2022; 2. All patients eligible participants are >=18 years old and meet the diagnostic criteria for systemic lupus erythematosus by the American College of Rheumatology or the systemic lupus erythematosus international cooperative clinic for systemic lupus erythematosus criteria; 3. Seropositive antinuclear antibodies (ANAs) and/or anti-double-stranded DNA (anti-dsDNA) antibody screening are required; 4. Some people have active serious disease. Defined as having a British Isles Lupus Assessment (BILAG) organ system score of >=1 (severe disease activity) or having a BILAGB score (moderate disease activity); 5. From April 2014 to June 2016, a total of 42 patients who received conventional treatment were included as historical controls.

Exclusion criteria

Exclusion criteria: 1. Coexistence of another autoimmune disease; 2. Any known intolerance or contraindication to CTX and other DMARDs, acute infection, cancer or other malignant disease, other connective tissue disease.

Design outcomes

Primary

MeasureTime frame
BILAG;

Countries

China

Contacts

Public ContactWen Hongyan

The Second Hospital of Shanxi Medical University

wenhongyan0509@aliyun.com+86 13835142566

Outcome results

None listed

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