Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Telitacicept, approved conditionally in China in March 2021, is a biologic agent targeting B lymphocyte stimulator (BLyS)and a proliferating inducing ligand (APRIL) dually for patients with active SLE patients who have not responded to conventional treatment. The investigators hope to screen predictive biomarkers of efficacy and explore the mechanism of difference in efficacy of Telitacicept with Chinese characteristics by omics.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• Patients with a clinical diagnosis of SLE according to American College of Rheumatology (ACR) classification criteria 1997 and clinically active disease.

• Patients with good compliance, will sign the informed consent before the test.

• Patients who have received conventional treatment for SLE, and the type and dose of treatment drugs have been stable for at least 30 days.

• Patients who have a positive anti-nuclear antibody test result and SELENA-SLEDAI score ≥8 at screening. If there is a low complement and/or positive anti-dsDNA antibody, the SELENA-SLEDAI score can be defined as ≥ 6 points.

Locations
Other Locations
China
Department of Rheumatology and Immunology, Xiangya Second Hospital, Central South University
RECRUITING
Changsha
Contact Information
Primary
Fen Li, doctor
lifen0731@csu.edu.cn
0086-731-85295255
Backup
Hui yu Nie, bachelor
niehuiyu2022@163.com
0086-18113519492
Time Frame
Start Date: 2022-12-31
Estimated Completion Date: 2024-06-30
Participants
Target number of participants: 30
Treatments
Experimental: Experimental Group
The treatment regimen consists of four drugs, a glucocorticoid plus Telitacicept plus hydroxychloroquine plus an immunosuppressor.~Prednisone(30mg, Qd) or Methylprednisolone(24mg, Qd) plus Telitacicept(160mg, Qw) plus Hydroxychloroquine (0.2g, Qd) plus cyclophosphamide(0.8g, Qm) or Mycophenolate Mofetil (0.5g, Bid) or Tacrolimus (1mg, Bid) The above treatment will continue for 24 weeks.
Related Therapeutic Areas
Sponsors
Leads: Fen Li

This content was sourced from clinicaltrials.gov