Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD

Sponsor
Wen Zhang
Study ID
NCT05781516
Status
Unknown

Conditions

  • IgG4-related Disease With Eosinophilia

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Prednisolone — DRUG
    Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.
  • Baricitinib — DRUG
    Oral Baricitinib 2mg daily for 12 months.

Study Details

Evaluation of efficacy and safety of Baricitinib combined with glucocorticoid in patients of IgG4-related disease with eosinophilia.

Key Dates

Start date
Jan 20, 2023
Status verified
Mar 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Prednisolone monotherapy
    Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.
  • Experimental: Prednisolone plus Baricitinib
    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.

Primary Outcome Measure

The difference of recurrent rate of IgG4-RD between the two groups [ Time Frame: 52 weeks ]

Central Contacts