IgG4-related Disease With EosinophiliaNCT05781516
Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD
A study testing Prednisolone and Baricitinib in people with IgG4-related Disease With Eosinophilia, run by Wen Zhang at 1 site in China.
Trial summary
Evaluation of efficacy and safety of Baricitinib combined with glucocorticoid in patients of IgG4-related disease with eosinophilia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IgG4-related Disease With Eosinophilia
- What is being tested?
- Prednisolone and Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Bejing, 100050
Linyi Peng, MD, +8615810395901, drpenglinyi@163.com
About this study
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
Evaluation of efficacy and safety of Baricitinib combined with glucocorticoid in patients of IgG4-related disease with eosinophilia.
Read the 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.
- Conditions
- IgG4-related Disease With Eosinophilia
- Being tested
- Prednisolone, Baricitinib
- Keywords
- IgG4-related disease, eosinophilia
- Medical subject headings
- Immunoglobulin G4-Related Disease, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.
BaricitinibDrug
Oral Baricitinib 2mg daily for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone monotherapy | Placebo comparator | Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. Receives: Drug: Prednisolone |
| Prednisolone plus Baricitinib | Experimental | 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. Receives: Drug: Prednisolone; Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 52 weeks
The changes of blood Eosinophil cells
Percentages (%) and counts (109) of peripheral eosinophil cells
Measured: 52 weeks
The changes of serum IgG levels
Level of serum IgG(g/L)
Measured: 52 weeks
The changes of serum IgG4 levels
Level of serum IgG4(mg/dL)
Measured: 52 weeks
The changes of serum hsCRP level
Level of serum high-sensitivity C-reactive protein level(mg/L)
Measured: 52 weeks
The changes of ESR
Serum erythrocyte sedimentation rate(mm/h)
Measured: 52 weeks
The percentages of adverse events
Adverse effect of drugs
Measured: 52 weeks
The changes of PGA
Changes of patient global assessment from baseline, score (0-10, higher is worse)
Measured: 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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start20 Jan 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgG4-related Disease With EosinophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, Beijing Friendship Hospital
- Responsible party
- Sponsor-investigator, Wen Zhang, Peking Union Medical College Hospital
- Investigators
- Wen Zhang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781516
- Sponsor's protocol ID
- Baricitinib for Eosinophilia
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05781516
- Acronym / sponsor ID
- Baricitinib for Eosinophilia
- Conditions
- IgG4-related Disease With Eosinophilia
- Keywords
- IgG4-related disease, eosinophilia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Wen ZhangUniversity, hospital or other
- Collaborators
- Tongji Hospital, Beijing Friendship Hospital
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone monotherapy | Placebo comparator | Drug: PrednisoloneOral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. |
| Prednisolone plus Baricitinib | Experimental | Drug: Prednisolone, Drug: BaricitinibOral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. Oral Baricitinib 2mg daily for 12 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoloneOral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. | Drug | Prednisolone monotherapy, Prednisolone plus Baricitinib |
| BaricitinibOral Baricitinib 2mg daily for 12 months. | Drug | Prednisolone plus Baricitinib |
Primary outcome
The difference of recurrent rate of IgG4-RD between the two groups
Time frame: 52 weeks
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.
10 secondary outcomes
The time of recurrence
Time frame: 0-52 weeks
The changes of IgG4-related disease Responder Index
Time frame: 52 weeks
The changes of blood Eosinophil cells
Time frame: 52 weeks
The changes of serum IgG levels
Time frame: 52 weeks
The changes of serum IgG4 levels
Time frame: 52 weeks
The changes of serum hsCRP level
Time frame: 52 weeks
The changes of ESR
Time frame: 52 weeks
The percentages of adverse events
Time frame: 52 weeks
The changes of PGA
Time frame: 52 weeks
The results of High-throughput analysis
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Zhang, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone and Baricitinib in people with IgG4-related Disease With Eosinophilia, run by Wen Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linyi Peng, MD (+8615810395901, drpenglinyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of recurrent rate of IgG4-RD between the two groups (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.