ClinicalTrials.gov record NCT05789030
Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement
Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a 12-month, open-label randomized trial enrolling 60 people with IgG4-related disease affecting superficial organs. It compares two drug strategies: prednisone plus iguratimod versus prednisone plus leflunomide. The main measure is the difference in relapse rates between the two groups at 12 months.
What it is studying. The study is testing whether relapse rates at 12 months differ between two treatment strategies for IgG4-related disease with superficial organ involvement: prednisone combined with iguratimod versus prednisone combined with leflunomide. It also records time to relapse, response rates, and side effects during the 12-month follow-up.
What the researchers hope to learn. Determine whether relapse rates differ between the two drug combinations at 12 months; compare time to relapse, response rates (complete/partial/no response), and side effects between groups.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This study has been designed as a 12-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with superficial organ involvement: prednisone plus iguratimod and prednisone plus leflunomide.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- glucocorticoid plus iguratimod
- glucocorticoid plus leflunomide
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria; 2. Newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment; 3. The addition of glucocorticoids was started at lower than 10 mg/d.
Exclusion criteria
- Patients who were diagnosed as other autoimmune diseases; 2. Patients who were diagnosed as malignant diseases; 3. Pregnant and lactating women； 4. Active infection: HIV, HCV, HBV, TB； 5. Severe irreversible damage of organ function; 6. Receipt of any biologic therapy or immunosuppressive agent other than GCs.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
60 IgG4-RD patients with superficial organ involvement are enrolled in this study and randomly divided into two groups at a 1:1 ratio: Patients in Group I are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≤5mg in 3 months) and iguratimod (25 mg bid). Patients in Group II are treated with prednisone (≤20 mg qd, or equivalent glucocorticoid, taper to ≤5mg in 3 months ) and leflunomide (10-20 mg qd).All patients will be followed up for 12 months, and clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded during follow up. The primary endpoint is the difference of relapse rate between two groups at 12 months. The secondary endpoints are relapse time, response rate and side effects.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are randomly assigned to one of two drug strategies for 12 months: prednisone (≤20 mg daily, tapered to ≤5 mg within 3 months) plus iguratimod (25 mg twice daily), or prednisone (≤20 mg daily, tapered to ≤5 mg within 3 months) plus leflunomide (10–20 mg daily). During 12 months of follow-up there will be regular clinic visits with clinical evaluations, laboratory tests, imaging examinations, and recording of the IgG4‑RD Responder Index. The study team will record relapses, time to relapse, response rates, and any side effects. The registry lists these tests and visits; it does not add other procedures beyond clinical exams, labs, imaging, and the responder‑index assessments.
How the study is structured. Participants (total 60) are randomly assigned 1:1 to one of two treatment groups in an open-label, parallel design. Group I receives prednisone (up to 20 mg daily, tapered to ≤5 mg within 3 months) plus iguratimod 25 mg twice daily. Group II receives prednisone (same taper) plus leflunomide 10–20 mg daily. There is no masking; patients are followed for 12 months with clinical checks, laboratory tests, imaging, and recording of the IgG4-RD Responder Index.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on IgG4-related disease
Important dates
- Study start
- Jul 1, 2022
- Primary completion
- Apr 30, 2026 (estimated)
- Study completion
- Apr 30, 2026 (estimated)
- Target enrollment
- 60 participants (estimated)
- Last updated on registry
- Apr 7, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Peking Union Medical College Hospital
- Principal investigator
- Wen Zhang, Professor
Peking Union Medical College Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Yunyun Fei, MD 📞 01069159953 ✉ feiyunyun@pumch.cn
Participating sites (1)
- Peking Union Medical College HospitalRecruiting
Beijing · China
- Yunyun Fei, MD · 01069159953 · feiyunyun@pumch.cn
- Wen Zhang, MD
Terms used on this page · explanations by MedicalUpdates.ai
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- prednisone
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- relapsed
- A condition that improved with treatment and has since returned or worsened.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- 1:1
- How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
- follow up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- primary endpoint
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- endpoints
- Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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