The Efficacy and Safety of Telitacicept in the Treatment of Early Diffuse Cutaneous Systemic Sclerosis: a Multicenter, Open-label, Randomized Controlled Study
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Men or women aged 18-70 years old.
• Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria.
• dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria.
• Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation).
• ≥ 10 mRSS units at the screening visit.
• Negative serum pregnancy test in a woman of childbearing potential at the screening visit.
• Ability to render informed consent in accordance with institutional guidelines.
Locations
Other Locations
China
Hangzhou First People's Hospital
RECRUITING
Hangzhou
Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine
RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Changxing People's Hospital
RECRUITING
Huzhou
The First Hospital of Jiaxing
RECRUITING
Jiaxing
Ningbo First Hospital
RECRUITING
Ningbo
Huashan Hospital of Fudan University
RECRUITING
Shanghai
The First Affiliated Hospital of Wenzhou Medical University
All patients who enroll in this trial will receive mycophenolate mofetil (MMF), which is a drug commonly given to patients with systemic sclerosis in clinical practice. Participants will be treated with MMF 0.5g twice a day for 48 weeks. Telitacicept will be subcutaneously injected at a dose of 160mg per week, lasting for 48 weeks.
Active_comparator: Mycophenolate Mofetil
Participants will be treated with MMF 0.5g twice a day for 48 weeks.