Immunoglobulin G4-Related DiseaseNCT07827469
Tofacitinib in the Treatment of IgG4 Related Diseases
A study testing Tofacitinib 5mg Oral Tablet and Prednisone 5mg in people with Immunoglobulin G4-Related Disease and Janus Kinase Inhibitors, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study is a single centre, open label, randomized controlled study to compare the efficacy and safety between steroids plus tofacitinib and steroids alone in active IgG4-related diseases patients. It is expected to enroll a total of 58 IgG4 RD patients. The sample size of two groups is 1:1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Immunoglobulin G4-Related Disease, Janus Kinase Inhibitors
- What is being tested?
- Tofacitinib 5mg Oral Tablet and Prednisone 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 3 Jun 2026
- 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
- 18 ≤ Age ≤ 70 years old;
- Complies with the 2019 ACR/EULAR IgG4 RD classification criteria
- Patients with initial or recurrent active IgG4 RD (IgG4 RD RI ≥ 3 points).
- Voluntary signing of informed consent: Patients must be given a written consent form when participating in the trial, and it is hoped that patients can comply with the requirements of the study follow-up plan and other protocols;
- Female participants of childbearing age agreed to use effective contraceptive measures during the study period.
Who cannot join
- Participants in other trials or those who have participated in clinical trials of other drugs within 2 months;
- Individuals who have received live vaccine immunization within 2 weeks prior to enrollment, or who require live vaccine immunization during the trial period;
- Merge other autoimmune diseases
- Active infected individuals need to be excluded. Latent tuberculosis requires prevention with isoniazid 0.3g/d one month in advance; People with hepatitis B HBsAg+and HBV-DNA negative need to take anti hepatitis B virus drugs one month in advance.
- Pregnant and lactating women, or women of childbearing age who have fertility requirements during the study period and within 6 months after the last dose of medication;
- Patients with a history of thromboembolism, or severe diseases such as coronary heart disease and other important organs such as the heart, brain, liver, lung, kidney, and hematopoietic system, malignant tumors, and psychiatric disorders;
- Other researchers believe that it is not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Univercity, People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Randomized Open Label Clinical Study on the Efficacy of Tofacitinib in the Treatment of IgG4 Related Diseases
This study is a single centre, open label, randomized controlled study to compare the efficacy and safety between steroids plus tofacitinib and steroids alone in active IgG4-related diseases patients. It is expected to enroll a total of 58 IgG4 RD patients. The sample size of two groups is 1:1.
The primary end points of this study is to compare the IgG4-RD response rate between two groups at 24 weeks.
- Being tested
- Tofacitinib 5mg Oral Tablet, Prednisone 5mg
- Keywords
- IgG4-related Disease, Tofacitinib,efficacy, safety
- Medical subject headings
- Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 5mg Oral TabletDrug
all subjects were trteated immediately after ranomized enrollment. Patients in experimental arm is treated with tofacitinib plus prednisone.
Prednisone 5mgDrug
all subjects were trteated immediately with prednisone after ranomized enrollment.
| Study group | Role | What they receive |
|---|---|---|
| steroids plus tofacitinib | Experimental | Prednisone (or equivalent drug) 0.6mg/kg/d orally. When the calculated values of two groups of prednisone are not multiples of 5, the dose of prednisone less than 5mg is rounded off. The initial dose should not exceed 60mg/day. If it exceeds 60mg/day, the medication should be administered at a rate of 60mg/day. Reduce the dosage by 5 mg every 2 weeks until reaching the maintenance dose of 5 mg/d.
Tofacitinib: 5mg,bid Receives: Drug: Tofacitinib 5mg Oral Tablet; Drug: Prednisone 5mg |
| steroids alone | Placebo comparator | Prednisone (or equivalent drug) 0.6mg/kg/d orally. When the calculated values of two groups of prednisone are not multiples of 5, the dose of prednisone less than 5mg is rounded off. The initial dose should not exceed 60mg/day. If it exceeds 60mg/day, the medication should be administered at a rate of 60mg/day. Reduce the dosage by 5 mg every 2 weeks until reaching the maintenance dose of 5 mg/d. Receives: Drug: Prednisone 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG4-RD remission rate
Evaluate treatment response by assessing changes in the IgG4 RD RI score and categorize it into three types: complete response (CR), partial response (PR), and no effect (NE, including no improvement or deterioration). IgG4 RD RI score<3 and a decrease of ≥ 2 is considered CR; A decrease of ≥ 2 in IgG4 RD RI score but a maintenance of ≥ 3 is considered PR. If the patient's IgG4 RD RI score is initially 3 points, a decrease of 1 point after treatment is considered PR. Patients with no significant changes in tumor size and/or clinical presentation and a decrease in IgG4 RD RI score<2 are considered NE.
Measured: 24 week
Secondary outcomes (3)
recurrence rate
compare the recurrence rates between two groups
Measured: 24 week
serum IgG4
compare the value of serum IgG4 between two groups
Measured: 24 week
rate of adverse events
Compare the incidence of treatment-related adverse events and treatment-related serious adverse events
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Apr 2023
- Primary completion3 Jun 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin G4-Related DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Hua, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827469
- Sponsor's protocol ID
- TIRED
- Status last verified
- Jan 2024
- First submitted
- 15 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Clinical Study on the Efficacy of Tofacitinib in the Treatment of IgG4 Related Diseases
- ClinicalTrials.gov ID
- NCT07827469
- Acronym / sponsor ID
- TIRED
- Keywords
- IgG4-related Disease, Tofacitinib,efficacy, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 3 Jun 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 18 Sep 2026 (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.
This study is a single centre, open label, randomized controlled study to compare the efficacy and safety between steroids plus tofacitinib and steroids alone in active IgG4-related diseases patients. It is expected to enroll a total of 58 IgG4 RD patients. The sample size of two groups is 1:1.
The primary end points of this study is to compare the IgG4-RD response rate between two groups at 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| steroids plus tofacitinib | Experimental | Drug: Tofacitinib 5mg Oral Tablet, Drug: Prednisone 5mgPrednisone (or equivalent drug) 0.6mg/kg/d orally. When the calculated values of two groups of prednisone are not multiples of 5, the dose of prednisone less than 5mg is rounded off. The initial dose should not exceed 60mg/day. If it exceeds 60mg/day, the medication should be administered at a rate of 60mg/day. Reduce the dosage by 5 mg every 2 weeks until reaching the maintenance dose of 5 mg/d. Tofacitinib: 5mg,bid |
| steroids alone | Placebo comparator | Drug: Prednisone 5mgPrednisone (or equivalent drug) 0.6mg/kg/d orally. When the calculated values of two groups of prednisone are not multiples of 5, the dose of prednisone less than 5mg is rounded off. The initial dose should not exceed 60mg/day. If it exceeds 60mg/day, the medication should be administered at a rate of 60mg/day. Reduce the dosage by 5 mg every 2 weeks until reaching the maintenance dose of 5 mg/d. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 ≤ Age ≤ 70 years old;
- Complies with the 2019 ACR/EULAR IgG4 RD classification criteria
- Patients with initial or recurrent active IgG4 RD (IgG4 RD RI ≥ 3 points).
- Voluntary signing of informed consent: Patients must be given a written consent form when participating in the trial, and it is hoped that patients can comply with the requirements of the study follow-up plan and other protocols;
- Female participants of childbearing age agreed to use effective contraceptive measures during the study period.
Key exclusion criteria (7 listed)
- Participants in other trials or those who have participated in clinical trials of other drugs within 2 months;
- Individuals who have received live vaccine immunization within 2 weeks prior to enrollment, or who require live vaccine immunization during the trial period;
- Merge other autoimmune diseases
- Active infected individuals need to be excluded. Latent tuberculosis requires prevention with isoniazid 0.3g/d one month in advance; People with hepatitis B HBsAg+and HBV-DNA negative need to take anti hepatitis B virus drugs one month in advance.
- Pregnant and lactating women, or women of childbearing age who have fertility requirements during the study period and within 6 months after the last dose of medication;
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 |
|---|---|---|
| Tofacitinib 5mg Oral Tabletall subjects were trteated immediately after ranomized enrollment. Patients in experimental arm is treated with tofacitinib plus prednisone. | Drug | steroids plus tofacitinib |
| Prednisone 5mgall subjects were trteated immediately with prednisone after ranomized enrollment. | Drug | steroids alone, steroids plus tofacitinib |
Primary outcome
IgG4-RD remission rate
Time frame: 24 week
Evaluate treatment response by assessing changes in the IgG4 RD RI score and categorize it into three types: complete response (CR), partial response (PR), and no effect (NE, including no improvement or deterioration). IgG4 RD RI score<3 and a decrease of ≥ 2 is considered CR; A decrease of ≥ 2 in IgG4 RD RI score but a maintenance of ≥ 3 is considered PR. If the patient's IgG4 RD RI score is initially 3 points, a decrease of 1 point after treatment is considered PR. Patients with no significant changes in tumor size and/or clinical presentation and a decrease in IgG4 RD RI score<2 are considered NE.
3 secondary outcomes
recurrence rate
Time frame: 24 week
serum IgG4
Time frame: 24 week
rate of adverse events
Time frame: 24 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tofacitinib 5mg Oral Tablet and Prednisone 5mg in people with Immunoglobulin G4-Related Disease and Janus Kinase Inhibitors, run by Peking University People's Hospital 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 18 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG4-RD remission rate (time frame: 24 week). 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 18 Sep 2026.