Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients

PHASE4RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 31, 2022

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2024

Conditions
Systemic Lupus Erythematosus
Interventions
BIOLOGICAL

Telitacicept

It is necessary and will be given by subcutaneous injection of 160mg/week for 24 weeks.

DRUG

Hydroxychloroquine

It is necessary and will be given by oral administration of 0.2g/day for 24 weeks.

DRUG

Prednisone

It is permitted which can be interchangeable with methylprednisolone. It will be given by oral administration of 30mg/day from beginning and be lowed dosage during the treatment of 24 weeks.

DRUG

Methylprednisolone

It is permitted which can be interchangeable with prednisone. It will be given by oral administration of 24mg/day from beginning and be lowed dosage during the treatment of 24 weeks.

DRUG

Cyclophosphamide

It is permitted which can be interchangeable with mycophenolate mofetil or tacrolimus. It will be given by oral administration of 0.8g/month for 24 weeks.

DRUG

Mycophenolate Mofetil

It is permitted which can be interchangeable with cyclophosphamide or tacrolimus. It will be given by oral administration of 0.5g twice a day for 24 weeks.

DRUG

Tacrolimus

It is permitted which can be interchangeable with cyclophosphamide or mycophenolate mofetil. It will be given by oral administration of 1mg twice a day for 24 weeks.

Trial Locations (1)

410000

RECRUITING

Department of Rheumatology and Immunology, Xiangya Second Hospital, Central South University, Changsha

All Listed Sponsors
lead

Fen Li

OTHER