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Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD

Primary Purpose

IgG4-related Disease With Eosinophilia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prednisolone
Baricitinib
Sponsored by
Wen Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgG4-related Disease With Eosinophilia focused on measuring IgG4-related disease, eosinophilia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Active IgG4-RD (Responder Index ≥ 2 points for each involved organ) The counts of peripheral blood eosinophil cells ≥0.75×109/L Exclusion Criteria: Patients who is not able to discontinue GC Pregnancy or breastfeeding or planning to get pregnant within 2 years Received glucocorticoids, immunosuppressants, biological agents or JAK inhibitors within 3 months Allergic to Baricitinib Concomitant other autoimmune diseases Malignancy Chronic HBV infection, latent tuberculosis, or active infection Server liver or renal dysfunction, or heart failure.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Prednisolone monotherapy

Prednisolone plus Baricitinib

Arm Description

Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.

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.

Outcomes

Primary Outcome Measures

The 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.

Secondary Outcome Measures

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.
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.
The changes of blood Eosinophil cells
Percentages (%) and counts (109) of peripheral eosinophil cells
The changes of serum IgG levels
Level of serum IgG(g/L)
The changes of serum IgG4 levels
Level of serum IgG4(mg/dL)
The changes of serum hsCRP level
Level of serum high-sensitivity C-reactive protein level(mg/L)
The changes of ESR
Serum erythrocyte sedimentation rate(mm/h)
The percentages of adverse events
Adverse effect of drugs
The changes of PGA
Changes of patient global assessment from baseline, score (0-10, higher is worse)
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.

Full Information

First Posted
March 12, 2023
Last Updated
March 23, 2023
Sponsor
Wen Zhang
Collaborators
Tongji Hospital, Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05781516
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wen Zhang
Collaborators
Tongji Hospital, Beijing Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG4-related Disease With Eosinophilia
Keywords
IgG4-related disease, eosinophilia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prednisolone monotherapy
Arm Type
Placebo Comparator
Arm Description
Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.
Arm Title
Prednisolone plus Baricitinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Intervention Description
Oral Baricitinib 2mg daily for 12 months.
Primary Outcome Measure Information:
Title
The difference of recurrent rate of IgG4-RD between the two groups
Description
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
Secondary Outcome Measure Information:
Title
The time of recurrence
Description
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
Title
The changes of IgG4-related disease Responder Index
Description
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
Title
The changes of blood Eosinophil cells
Description
Percentages (%) and counts (109) of peripheral eosinophil cells
Time Frame
52 weeks
Title
The changes of serum IgG levels
Description
Level of serum IgG(g/L)
Time Frame
52 weeks
Title
The changes of serum IgG4 levels
Description
Level of serum IgG4(mg/dL)
Time Frame
52 weeks
Title
The changes of serum hsCRP level
Description
Level of serum high-sensitivity C-reactive protein level(mg/L)
Time Frame
52 weeks
Title
The changes of ESR
Description
Serum erythrocyte sedimentation rate(mm/h)
Time Frame
52 weeks
Title
The percentages of adverse events
Description
Adverse effect of drugs
Time Frame
52 weeks
Title
The changes of PGA
Description
Changes of patient global assessment from baseline, score (0-10, higher is worse)
Time Frame
52 weeks
Title
The results of High-throughput analysis
Description
The changes of results from baseline in High-throughput analysis, including GWAS, single cell sequencing of B cell receptor.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Active IgG4-RD (Responder Index ≥ 2 points for each involved organ) The counts of peripheral blood eosinophil cells ≥0.75×109/L Exclusion Criteria: Patients who is not able to discontinue GC Pregnancy or breastfeeding or planning to get pregnant within 2 years Received glucocorticoids, immunosuppressants, biological agents or JAK inhibitors within 3 months Allergic to Baricitinib Concomitant other autoimmune diseases Malignancy Chronic HBV infection, latent tuberculosis, or active infection Server liver or renal dysfunction, or heart failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linyi Peng, MD
Phone
+8615810395901
Email
drpenglinyi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Zhang, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Bejing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linyi Peng, MD
Phone
+8615810395901
Email
drpenglinyi@163.com

12. IPD Sharing Statement

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Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD

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