A Study Evaluating the Efficacy and Safety of Baricitinib in Systemic Sclerosis

Sponsor
Tongji Hospital
Study ID
NCT05300932
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Orally take Baricitinib 4mg everyday for 48 weeks
  • Cyclophosphamide — DRUG
    Subject received cyclophosphamide 400mg intravenous drip every 2 weeks combined with oral Prednisone 10-15 mg/d （standard of care）through the 24 weeks double blind period. Subsequently, subject were administered oral Baricitinib 4mg everyday through the 24-48 weeks open label period.

Study Details

Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the musculoskeletal, cardiac, pulmonary, and gastrointestinal systems. Patients may experience many symptoms such as pain, fatigue, dyspnea, impaired hand function, dry mouth, and difficulty sleeping. As a result of these symptoms, these patients may experience a decrease in activities of daily living, physical activity level and quality of life, while psychological problems such as anxiety and depression may increase.

Key Dates

Start date
Mar 8, 2022
Status verified
Jan 2026
Primary completion
Aug 1, 2026
Completion
Nov 12, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib 4mg
    4mg of oral Baricitinib everyday for 48 weeks.
  • Active Comparator: Cyclophosphamide
    Subject received cyclophosphamide 400mg intravenous drip every 2 weeks combined with oral Prednisone 10-15 mg/d （standard of care）through the 24 weeks double blind period. Subsequently, subject were administered oral Baricitinib 4mg everyday through the 24-48 weeks open label period.

Primary Outcome Measure

Change in modified Rodnan skin score (mRSS) at week 24 [ Time Frame: 24 weeks ]

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