Evaluation of efficacy and safety of Baricitinib combined with glucocorticoid in patients of IgG4-related disease with eosinophilia.
This is a multicenter, 52-week prospective, randomized controlled study to compare the efficacy and safety of Baricitinib combined with glucocorticoid and glucocorticoid monotherapy in proliferative IgG4-RD patients with eosinophilia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.
Oral Baricitinib 2mg daily for 12 months.
Peking Union Medical College Hospital
Beijing, Bejing, China
RECRUITINGThe difference of recurrent rate of IgG4-RD between the two groups
Clinical recurrence definition: any item of IgG4-RD Responder Index ≥2 (without treatment), or ≥ 3 (with treatment) or new organ involvement; with or without elevated serum IgG4 levels.
Time frame: 52 weeks
The time of recurrence
Clinical recurrence definition: any item of IgG4-RD Responder Index ≥2 (without treatment), or ≥ 3 (with treatment) or new organ involvement; with or without elevated serum IgG4 levels.
Time frame: 0-52 weeks
The changes of IgG4-related disease Responder Index
According to international multispecialty validation study of IgG4-related disease Responder Index (Version: 13, December, 2015), Responder Index ≥ 0, and higher scores mean a worse outcome.
Time frame: 52 weeks
The changes of blood Eosinophil cells
Percentages (%) and counts (109) of peripheral eosinophil cells
Time frame: 52 weeks
The changes of serum IgG levels
Level of serum IgG(g/L)
Time frame: 52 weeks
The changes of serum IgG4 levels
Level of serum IgG4(mg/dL)
Time frame: 52 weeks
The changes of serum hsCRP level
Level of serum high-sensitivity C-reactive protein level(mg/L)
Time frame: 52 weeks
The changes of ESR
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Serum erythrocyte sedimentation rate(mm/h)
Time frame: 52 weeks
The percentages of adverse events
Adverse effect of drugs
Time frame: 52 weeks
The changes of PGA
Changes of patient global assessment from baseline, score (0-10, higher is worse)
Time frame: 52 weeks
The results of High-throughput analysis
The changes of results from baseline in High-throughput analysis, including GWAS, single cell sequencing of B cell receptor.
Time frame: 52 weeks