An interventional study of Tofacitinib 5mg Oral Tablet and Prednisone 5mg in Immunoglobulin G4-Related Disease and Janus Kinase Inhibitors, sponsored by Peking University People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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Among 40 studies in Immunoglobulin G4-Related Disease with a site in China — 25 open to participants now, 28 under way, 5 of them phase 3. Immunoglobulin G4-Related Disease · China.
Among the 40 studies in Immunoglobulin G4-Related Disease with a site in China, this one is the 19th largest by enrollment of the 36 interventional ones that give a count, is one of 5 that started in 2023, is one of 10 with no phase, and was the 39th registered.
72 studies on the registry are indexed under Immunoglobulin G4-Related Disease; 40 are open to participants now.
Browse Immunoglobulin G4-Related Disease studies →25 of the 40 studies in Immunoglobulin G4-Related Disease with a site in China are open now. Recruiting first, the newest first:
Amgen · Sites in China, United States, Brazil and 5 more countries
Ages 2–18
Acepodia Biotech, Inc. · Sites in China, United States, Japan
Ages 18+
Sanofi · Sites in China, United States, Argentina and 16 more countries
Ages 18+
Chinese PLA General Hospital · Sites in China
Ages 18–75
Peking Union Medical College Hospital · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 28 Immunoglobulin G4-Related Disease studies recruiting now, 12 (43%) set no upper age limit and 13 (46%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 8 · Phase 3 6 · Phase 4 3
First in 2012; this study’s year is marked. 5 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 58 is above the median of 48 across 52 interventional studies indexed under Immunoglobulin G4-Related Disease.
Median enrollment 59 across the 36 interventional studies, 780 across the 4 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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7 of 40 have an industry lead sponsor. The 10 most frequent:
Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.
Peking University People's Hospital has 2 studies filed under Immunoglobulin G4-Related Disease — fewer than ten, so there is no comparison to draw.
7 of the studies in Immunoglobulin G4-Related Disease with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03023371Peking Union Medical College HospitalNational Registry of IgG4-RD in China | 2026-12 |
| NCT06285279Nanjing University School of MedicineThe BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases | 2026-12-31 |
| NCT06978738Changzhou No.2 People's HospitalUCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases | 2027-05 |
| NCT06978647China Immunotech (Beijing) Biotechnology Co., Ltd.A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases | 2027-05-19 |
| NCT06497387Tongji HospitalSafety and Efficacy of PRG-1801 for Refractory Lupus Nephritis and IgG4-Related Disease | 2027-07 |
Add all 7 to your calendar (.ics) → With an account.
Among the 40 studies in Immunoglobulin G4-Related Disease with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Tofacitinib 5mg Oral Tablet · Drug: Prednisone 5mg
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.
Drug: Prednisone 5mg
all subjects were trteated immediately after ranomized enrollment. Patients in experimental arm is treated with tofacitinib plus prednisone.
all subjects were trteated immediately with prednisone after ranomized enrollment.
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.
Time frame: 24 week
recurrence rate
compare the recurrence rates between two groups
Time frame: 24 week
serum IgG4
compare the value of serum IgG4 between two groups
Time frame: 24 week
rate of adverse events
Compare the incidence of treatment-related adverse events and treatment-related serious adverse events
Time frame: 24 week
Ran from Apr 2023 to primary completion in Jun 2026, 38 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tofacitinib
Immunoglobulin G4-Related Disease →
Peking University People's Hospital →