Clinical trial NCT05781516: Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD
Official title: A 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
Overall status: UNKNOWN
Phase: NA
Conditions: IgG4-related Disease With Eosinophilia
Keywords: IgG4-related disease
eosinophilia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Tongji Hospital
name: Beijing Friendship Hospital
First posted: 2023-03-23
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. All patients must meet the following diagnostic criteria of IgG4RD (2020): 1) and radiological features: One or more organs show diffuse or localized swelling or a mass or nodule characteristic of IgG4-RD. In single organ involvement, lymph node swelling is omitted. 2) serological diagnosis: Serum IgG4 levels greater than 135 mg/dl. 3) diagnosis diagnosis: Positivity for two of the following three criteria: a. Dense lymphocyte and plasma cell infiltration with fibrosis. b. Ratio of IgG4-positive plasma cells /IgG-positive cells greater than 40% and the number of IgG4-positive plasma cells greater than 10 per high powered field. c. Typical tissue fibrosis, particularly storiform fibrosis, or obliterative phlebitis.

   Patients fulfill (1) + (2) + (3) are diagnosed as definite IgD4RD; (1) + (2): possible IgG4RD; (1) + (3): probable IgG4RD. exclusion of other diseases.
2. Active IgG4-RD (Responder Index ≥ 2 points for each involved organ)
3. The counts of peripheral blood eosinophil cells ≥0.75×109/L

Exclusion Criteria:

1. Patients who is not able to discontinue GC
2. Pregnancy or breastfeeding or planning to get pregnant within 2 years
3. Received glucocorticoids, immunosuppressants, biological agents or JAK inhibitors within 3 months
4. Allergic to Baricitinib
5. Concomitant other autoimmune diseases
6. Malignancy
7. Chronic HBV infection, latent tuberculosis, or active infection
8. Server liver or renal dysfunction, or heart failure.

Primary outcomes:
measure: The difference of recurrent rate of IgG4-RD between the two groups
timeFrame: 52 weeks
Secondary outcomes:
measure: The time of recurrence
timeFrame: 0-52 weeks
measure: The changes of IgG4-related disease Responder Index
timeFrame: 52 weeks
measure: The changes of blood Eosinophil cells
timeFrame: 52 weeks
measure: The changes of serum IgG levels
timeFrame: 52 weeks
measure: The changes of serum IgG4 levels
timeFrame: 52 weeks
measure: The changes of serum hsCRP level
timeFrame: 52 weeks
measure: The changes of ESR
timeFrame: 52 weeks
measure: The percentages of adverse events
timeFrame: 52 weeks
measure: The changes of PGA
timeFrame: 52 weeks
measure: The results of High-throughput analysis
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Bejing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wen Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: