A clinical study on the effect of Telitacicept on lymphocyte subsets in the treatment of moderate to severe active systemic lupus erythematosus

The Effect of Telitacicept on the Lymphocyte Subsets in Moderate to severe active systemic lupus erythematosus

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400086874

Enrollment

Unknown

Registered

2024-07-14

Start date

2022-01-06

Completion date

Unknown

Last updated

2024-07-15

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

Conditions

Systemic lupus erythematosus

Interventions

Experimental group:Conventional treatment+Telitacicept

Eligibility

Sex/Gender

All

Age

19 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age range from 18 to 65 years old, regardless of gender; 2. Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria; 3. Provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Known to be allergic to research drugs; 2. Pregnancy or breastfeeding women; 3. Receipt of treatment with belimumab; 4. Receipt of B-cell targeted therapy such as rituximab or iprazumab; 5. Participating in other drugs clinical trials; 6. Subjects who in the opinion of the investigator are not suitable to participate.

Design outcomes

Primary

Measure	Time frame
SLE Responder Index (SRI-4) [ Time Frame: Week 24 ];	—

Secondary

Measure	Time frame
Proportion of patients achieving SELENA–SLEDAI decrease of = 4 points;Changes in serum and immunological indicators (IgG, IgA, IgM, complement (C3, C4), IL-6, IL-10, TNFa, etc.);	—

Countries

China

Contacts

Public ContactSun Li

The FIrst Affiliated Hospital of Wenzhou Medical University

grassandsun@126.com+86 137 7775 0055

Outcome results

None listed

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