The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with early stage of SLE .
This is a phase 4, multicentre, randomised, double-blind, open-labeled study to evaluate the efficacy and safety of telitacicept in adult subjects with active early stage of SLE (disease duration less than 2 years).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
160mg once a week for 48 weeks
Steroid(≤1mg/kg/d) with or without proper immunosuppressants:CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China
Proportion of LLDAS in week 24
Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials
Time frame: week 24
Proportion of LLDAS in week 12
Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials
Time frame: week 12
Improvement in SLEDAI-2K
Proportion of patients with SLEDAI-2K scores improvement ≥4 compared with baseline
Time frame: week 24 and 52
Improvement in serological indices
Improvement in anti-dsDNA antibody titers, C3, C4, T cell and B cell subsets and IgG, IgA, IgM compared with baseline
Time frame: week 24, 52
Change in PGA
PGA: physician global assesment(0-3)
Time frame: week 24, 52
Number of participants with Adverse Events
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose resulting in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant and which the investigator regards as serious based on appropriate medical judgment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peking University Third Hospital
Beijing, China
ACTIVE_NOT_RECRUITINGFuyang People's Hospital
Fuyang, China
ACTIVE_NOT_RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, China
ACTIVE_NOT_RECRUITINGNanfang Hospital, Southern Medical University
Guanzhou, China
ACTIVE_NOT_RECRUITINGQilu Hospital of Shandong University
Jinan, China
ACTIVE_NOT_RECRUITINGthe First People's Hospital of Yunnan Province
Kunming, China
ACTIVE_NOT_RECRUITINGThe Second Affiliated Hospital of Lanzhou University
Lanzhou, China
ACTIVE_NOT_RECRUITINGThe Affiliated Hospital of Nantong University
Nantong, China
ACTIVE_NOT_RECRUITINGthe Affiliated Hospital of Qingdao University
Qingdao, China
ACTIVE_NOT_RECRUITING...and 10 more locations
Time frame: up to week 52
Disease flare
Proportion of patients suffer from SLE flare
Time frame: up to week 52