Study of Telitacicept and Mycophenolate Mofetil for Early Diffuse Cutaneous Systemic Sclerosis in Adults

What this Trial Is About

This research aims to evaluate the effectiveness and safety of Telitacicept combined with Mycophenolate Mofetil MMF in adults diagnosed with early diffuse cutaneous systemic sclerosis dcSSc. The study is a prospective, open-label, randomized, controlled, multi-center clinical trial focusing on patients with this specific form of systemic sclerosis. Participants in this trial will all receive MMF orally at 0.5 grams twice daily for 48 weeks as background treatment. In addition, one group will receive weekly subcutaneous injections of Telitacicept at a dose of 160 mg for 48 weeks. The study compares the combination therapy against MMF alone over this treatment period. Throughout the 48 weeks of treatment, participants will undergo assessments including the Modified Rodnan Skin Score mRSS to measure skin thickness and other evaluations such as lung function tests and patient and physician health assessments. Safety will be monitored through tracking adverse events up to week 52. The total participation duration includes treatment and follow-up to observe both efficacy and safety outcomes.

Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis