Autoimmune DiseasesNCT05974683
Treatment Strategies in IgG4-RD Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period
A study testing mycophenolate mofetil in people with Autoimmune Diseases, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study has been designed as a 52-week, randomized double blind placebo controlled multicenter clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with re-elevation of serum IgG4 level during maintenance remission period: basic maintenance treatment… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- mycophenolate mofetil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to Dec 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
- 1. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria or the 2020 revised comprehensive diagnostic (RCD) criteria for IgG4-RD.
- 2. Age between 18 and 70 years.
- 3. Elevation of baseline serum IgG4 level (>1400mg/L).
- 4. Major organ involvement, including but not limited to autoimmune pancreatitis, retroperitoneal fibrosis, sclerosing cholangitis, IgG4-related Castleman disease, and involvement of the lungs, kidney, nasal sinus, and central nervous system.
- 5. Re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during maintenance remission period, with no evidence of relapse.
- 6. Written informed consent signed.
- 7. Agreed to take highly effective contraceptive procedures from signing of informed consent till 6 months after the end of last visit.
Who cannot join
- 1. Patients with an IgG4-RD Responder Index ≥ 2 points of any organ system.
- 2. IgG4-RD patients without major organ involvement.
- 3. Patients with severe or active infections, including but not limited to HIV, HCV, HBV, TB.
- 4. Patients with malignancies or a history of malignancies within 5 years, except:
- Patients with adenocarcinoma in situ (AIS) of the cervix who have received curative treatment for at least 12 months before screening.
- Patients with cutaneous basal or squamous cell carcinoma who have received curative treatment.
Show all 21Show fewer
- Patients with prostate cancer, who have received radical prostatectomy or definitive radiotherapy for over 3 years, with no sign of relapse or ongoing treatment
- 5. Patients with immunodeficiency diseases.
- 6. Patients with severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neuropsychological, or constitutional comorbidities; or at risk of unacceptable complications, or having confounding factors in safety and explanation of results according to the evaluations from investigators.
- 7. Patients with other rheumatic diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, sarcoidosis; or other mimickers of IgG4-RD, including but not limited to Rosai-Dorfman disease, Castleman disease.
- 8. Participating in any other clinical trials with drug interventions.
- 9. A history of alcohol or drug abuse, possibly harming patient's safety, compliance, or evaluation of study's safety or other necessary aspects according to the evaluations from investigators.
- 10. Women during pregnancy, lactation, or planning of pregnancy within 6 months of the last visit of the study.
- 11. Meeting any of the following blood test finding on screening:
- Hemoglobin level < 7.5g/dL.
- neutrophil count < 1.0×10^9/L.
- Platelet count < 100×10^9/L.
- Alanine aminotransferase (ALT) > 2 × upper limit number (ULN).
- Aspartate aminotransferase (AST) > 2 × ULN.
- Total Bilirubin (TBil) > 2 × ULN.
- Estimated glomerular filtration rate (eGFR) < 30ml/(min·1.73m^2), calculated using the Modification of Diet in Renal Disease (MDRD) study equation by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing
Jiaxin Zhou, ND, 86-10-69155647, pumczhou@sina.com
Linyi Peng, MD, 86-10-69155647, pumczhou@sina.com
About this study
Official title: A Study of Two Different Treatment Strategies in IgG4-related Disease Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period: a Randomized Double Blind Placebo Controlled Multicenter Study
This study has been designed as a 52-week, randomized double blind placebo controlled multicenter clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with re-elevation of serum IgG4 level during maintenance remission period: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD).
Read the detailed description
108 IgG4-RD patients with re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during maintenance remission period are to be enrolled in this study after screening period, and then double blind randomly in an 1:1 ratio into two groups: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD plus placebo) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD). The follow-up period will be 52 weeks. During the follow-up period, clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded. The primary endpoint is the difference of relapse rate between two groups at 52 weeks. Meanwhile, this study will also explore and study different biomarkers in IgG4-RD patients, to better understand the mechanisms, as well as prognostic factors of IgG4-RD.
- Conditions
- Autoimmune Diseases
- Being tested
- placebo, mycophenolate mofetil
- Keywords
- Immunoglobulin G4-Related Disease, Drug therapy, Relapse
- Medical subject headings
- Autoimmune Diseases, Immunoglobulin G4-Related Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Continue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
Use low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
| Study group | Role | What they receive |
|---|---|---|
| Basic Maintenance Treatment | Placebo comparator | Continue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52 Receives: Drug: placebo |
| Enhancement Treatment | Active comparator | Use low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52 Receives: Drug: mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of relapse rate of IgG4-RD between two groups in week 52.
The primary endpoint is the difference of relapse rate between two groups at 52 weeks. The definition of relapse: elevation of IgG4-RD Responder Index ≥ 2 points; new organ involvement or recurrence, with or without elevation of serum IgG4 levels.
Measured: 52 weeks
Secondary outcomes (11)
The difference of relapse rate of IgG4-RD between two groups in the week 12.
Measured: 12 weeks
The difference of relapse rate of IgG4-RD between two groups in the week 24
Measured: 24 weeks
The difference of relapse rate of IgG4-RD between two groups in the week 36.
Measured: 36 weeks
The time and duration of relapse
Measured: 52 weeks
The changes of IgG4-RD Responder Index at week 52
Measured: 52 weeks
The changes of serum IgG level at week 52
Measured: 52 weeks
The changes of serum IgG4 level at week 52
Measured: 52 weeks
The changes of erythrocyte sedimentation rate at week 52
Measured: 52 weeks
The changes of serum C-reactive protein level at week 52
Measured: 52 weeks
Adverse effect events
Measured: 52 weeks
The changes of Physician Global Assessment score at week 52
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 posted3 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, Tongji Hospital
- Responsible party
- Principal 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
- NCT05974683
- Sponsor's protocol ID
- IgG4 re-elevation treatment
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhang W, Stone JH. Management of IgG4-related disease. Lancet Rheumatol. 2019 Sep;1(1):e55-e65. doi: 10.1016/S2665-9913(19)30017-7. Epub 2019 Aug 28.
PubMed 38229361Wallace ZS, Naden RP, Chari S, Choi HK, Della-Torre E, Dicaire JF, Hart PA, Inoue D, Kawano M, Khosroshahi A, Lanzillotta M, Okazaki K, Perugino CA, Sharma A, Saeki T, Schleinitz N, Takahashi N, Umehara H, Zen Y, Stone JH; Members of the ACR/EULAR IgG4-RD Classification Criteria Working Group. The 2019 American College of Rheumatology/European League Against Rheumatism classification criteria for IgG4-related disease. Ann Rheum Dis. 2020 Jan;79(1):77-87. doi: 10.1136/annrheumdis-2019-216561. Epub 2019 Dec 3.
PubMed 31796497Lin W, Lu S, Chen H, Wu Q, Fei Y, Li M, Zhang X, Tian X, Zheng W, Leng X, Xu D, Wang Q, Shen M, Wang L, Li J, Wu D, Zhao L, Wu C, Yang Y, Peng L, Zhou J, Wang Y, Sha Y, Huang X, Jiao Y, Zeng X, Shi Q, Li P, Zhang S, Hu C, Deng C, Li Y, Zhang S, Liu J, Su J, Hou Y, Jiang Y, You X, Zhang H, Yan L, Zhang W, Zhao Y, Zeng X, Zhang F, Lipsky PE. Clinical characteristics of immunoglobulin G4-related disease: a prospective study of 118 Chinese patients. Rheumatology (Oxford). 2015 Nov;54(11):1982-90. doi: 10.1093/rheumatology/kev203. Epub 2015 Jun 22.
PubMed 26106212Umehara H, Okazaki K, Kawa S, Takahashi H, Goto H, Matsui S, Ishizaka N, Akamizu T, Sato Y, Kawano M; Research Program for Intractable Disease by the Ministry of Health, Labor and Welfare (MHLW) Japan.. The 2020 revised comprehensive diagnostic (RCD) criteria for IgG4-RD. Mod Rheumatol. 2021 May;31(3):529-533. doi: 10.1080/14397595.2020.1859710. Epub 2021 Jan 28.
PubMed 33274670Khosroshahi A, Wallace ZS, Crowe JL, Akamizu T, Azumi A, Carruthers MN, Chari ST, Della-Torre E, Frulloni L, Goto H, Hart PA, Kamisawa T, Kawa S, Kawano M, Kim MH, Kodama Y, Kubota K, Lerch MM, Lohr M, Masaki Y, Matsui S, Mimori T, Nakamura S, Nakazawa T, Ohara H, Okazaki K, Ryu JH, Saeki T, Schleinitz N, Shimatsu A, Shimosegawa T, Takahashi H, Takahira M, Tanaka A, Topazian M, Umehara H, Webster GJ, Witzig TE, Yamamoto M, Zhang W, Chiba T, Stone JH; Second International Symposium on IgG4-Related Disease. International Consensus Guidance Statement on the Management and Treatment of IgG4-Related Disease. Arthritis Rheumatol. 2015 Jul;67(7):1688-99. doi: 10.1002/art.39132. No abstract available.
PubMed 25809420Yunyun F, Yu P, Panpan Z, Xia Z, Linyi P, Jiaxin Z, Li Z, Shangzhu Z, Jinjing L, Di W, Yamin L, Xiaowei L, Huadan X, Xuan Z, Xiaofeng Z, Fengchun Z, Yan Z, Wen Z. Efficacy and safety of low dose Mycophenolate mofetil treatment for immunoglobulin G4-related disease: a randomized clinical trial. Rheumatology (Oxford). 2019 Jan 1;58(1):52-60. doi: 10.1093/rheumatology/key227.
PubMed 30124952Peng Y, Li JQ, Zhang PP, Zhang X, Peng LY, Chen H, Zhou JX, Zhang SZ, Yang HX, Liu JJ, Guo HF, Li J, Zhang X, Zhao Y, Zeng XF, Zhang FC, Fei YY, Zhang W. Clinical outcomes and predictive relapse factors of IgG4-related disease following treatment: a long-term cohort study. J Intern Med. 2019 Nov;286(5):542-552. doi: 10.1111/joim.12942. Epub 2019 Jun 17.
PubMed 31121062Liu Z, Peng Y, Li J, Lu H, Peng L, Zhou J, Zhou S, Huang C, Wang M, Zhu L, Chen H, Wang L, Fei Y, Zhao Y, Zeng X, Zhang W. Prediction of new organ onset in recurrent immunoglobulin G4-related disease during 10 years of follow-up. J Intern Med. 2022 Jul;292(1):91-102. doi: 10.1111/joim.13477. Epub 2022 Apr 13.
PubMed 35419810Zhang J, Nie Y, Peng L, Fei Y, Liu Y, Dong L, Kong X, Fu M, Zhang X, Liu C, Chen Y, Li M, Zhou J, Zhang W. Efficacy and safety of mycophenolate mofetil in preventing relapse of IgG4-related disease with re-elevation of serum IgG4 level during maintenance therapy: a protocol for a multicentre, randomised, double-blind, placebo-controlled study in China. BMJ Open. 2026 Sep 11;16(9):e113850. doi: 10.1136/bmjopen-2025-113850.
PubMed 42731845
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Two Different Treatment Strategies in IgG4-related Disease Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period: a Randomized Double Blind Placebo Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT05974683
- Acronym / sponsor ID
- IgG4 re-elevation treatment
- Conditions
- Autoimmune Diseases
- Keywords
- Immunoglobulin G4-Related Disease, Drug therapy, Relapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, Tongji Hospital
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Aug 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.
This study has been designed as a 52-week, randomized double blind placebo controlled multicenter clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with re-elevation of serum IgG4 level during maintenance remission period: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD).
Detailed description
108 IgG4-RD patients with re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during maintenance remission period are to be enrolled in this study after screening period, and then double blind randomly in an 1:1 ratio into two groups: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD plus placebo) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD). The follow-up period will be 52 weeks. During the follow-up period, clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded. The primary endpoint is the difference of relapse rate between two groups at 52 weeks. Meanwhile, this study will also explore and study different biomarkers in IgG4-RD patients, to better understand the mechanisms, as well as prognostic factors of IgG4-RD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic Maintenance Treatment | Placebo comparator | Drug: placeboContinue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52 |
| Enhancement Treatment | Active comparator | Drug: mycophenolate mofetilUse low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria or the 2020 revised comprehensive diagnostic (RCD) criteria for IgG4-RD.
- 2. Age between 18 and 70 years.
- 3. Elevation of baseline serum IgG4 level (>1400mg/L).
- 4. Major organ involvement, including but not limited to autoimmune pancreatitis, retroperitoneal fibrosis, sclerosing cholangitis, IgG4-related Castleman disease, and involvement of the lungs, kidney, nasal sinus, and central nervous system.
- 5. Re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during maintenance remission period, with no evidence of relapse.
Key exclusion criteria (21 listed)
- 1. Patients with an IgG4-RD Responder Index ≥ 2 points of any organ system.
- 2. IgG4-RD patients without major organ involvement.
- 3. Patients with severe or active infections, including but not limited to HIV, HCV, HBV, TB.
- 4. Patients with malignancies or a history of malignancies within 5 years, except:
- 5. Patients with immunodeficiency 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 |
|---|---|---|
| placeboContinue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52 | Drug | Basic Maintenance Treatment |
| mycophenolate mofetilUse low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52 | Drug | Enhancement Treatment |
Primary outcome
The difference of relapse rate of IgG4-RD between two groups in week 52.
Time frame: 52 weeks
The primary endpoint is the difference of relapse rate between two groups at 52 weeks. The definition of relapse: elevation of IgG4-RD Responder Index ≥ 2 points; new organ involvement or recurrence, with or without elevation of serum IgG4 levels.
11 secondary outcomes
The difference of relapse rate of IgG4-RD between two groups in the week 12.
Time frame: 12 weeks
The difference of relapse rate of IgG4-RD between two groups in the week 24
Time frame: 24 weeks
The difference of relapse rate of IgG4-RD between two groups in the week 36.
Time frame: 36 weeks
The time and duration of relapse
Time frame: 52 weeks
The changes of IgG4-RD Responder Index at week 52
Time frame: 52 weeks
The changes of serum IgG level at week 52
Time frame: 52 weeks
The changes of serum IgG4 level at week 52
Time frame: 52 weeks
The changes of erythrocyte sedimentation rate at week 52
Time frame: 52 weeks
The changes of serum C-reactive protein level at week 52
Time frame: 52 weeks
Adverse effect events
Time frame: 52 weeks
The changes of Physician Global Assessment score at week 52
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 3 Aug 2023.
- Background: PubMed 38229361Zhang W, Stone JH. Management of IgG4-related disease. Lancet Rheumatol. 2019 Sep;1(1):e55-e65. doi: 10.1016/S2665-9913(19)30017-7. Epub 2019 Aug 28.
- Background: PubMed 31796497Wallace ZS, Naden RP, Chari S, Choi HK, Della-Torre E, Dicaire JF, Hart PA, Inoue D, Kawano M, Khosroshahi A, Lanzillotta M, Okazaki K, Perugino CA, Sharma A, Saeki T, Schleinitz N, Takahashi N, Umehara H, Zen Y, Stone JH; Members of the ACR/EULAR IgG4-RD Classification Criteria Working Group. The 2019 American College of Rheumatology/European League Against Rheumatism classification criteria for IgG4-related disease. Ann Rheum Dis. 2020 Jan;79(1):77-87. doi: 10.1136/annrheumdis-2019-216561. Epub 2019 Dec 3.
- Background: PubMed 26106212Lin W, Lu S, Chen H, Wu Q, Fei Y, Li M, Zhang X, Tian X, Zheng W, Leng X, Xu D, Wang Q, Shen M, Wang L, Li J, Wu D, Zhao L, Wu C, Yang Y, Peng L, Zhou J, Wang Y, Sha Y, Huang X, Jiao Y, Zeng X, Shi Q, Li P, Zhang S, Hu C, Deng C, Li Y, Zhang S, Liu J, Su J, Hou Y, Jiang Y, You X, Zhang H, Yan L, Zhang W, Zhao Y, Zeng X, Zhang F, Lipsky PE. Clinical characteristics of immunoglobulin G4-related disease: a prospective study of 118 Chinese patients. Rheumatology (Oxford). 2015 Nov;54(11):1982-90. doi: 10.1093/rheumatology/kev203. Epub 2015 Jun 22.
- Background: PubMed 33274670Umehara H, Okazaki K, Kawa S, Takahashi H, Goto H, Matsui S, Ishizaka N, Akamizu T, Sato Y, Kawano M; Research Program for Intractable Disease by the Ministry of Health, Labor and Welfare (MHLW) Japan.. The 2020 revised comprehensive diagnostic (RCD) criteria for IgG4-RD. Mod Rheumatol. 2021 May;31(3):529-533. doi: 10.1080/14397595.2020.1859710. Epub 2021 Jan 28.
- Background: PubMed 25809420Khosroshahi A, Wallace ZS, Crowe JL, Akamizu T, Azumi A, Carruthers MN, Chari ST, Della-Torre E, Frulloni L, Goto H, Hart PA, Kamisawa T, Kawa S, Kawano M, Kim MH, Kodama Y, Kubota K, Lerch MM, Lohr M, Masaki Y, Matsui S, Mimori T, Nakamura S, Nakazawa T, Ohara H, Okazaki K, Ryu JH, Saeki T, Schleinitz N, Shimatsu A, Shimosegawa T, Takahashi H, Takahira M, Tanaka A, Topazian M, Umehara H, Webster GJ, Witzig TE, Yamamoto M, Zhang W, Chiba T, Stone JH; Second International Symposium on IgG4-Related Disease. International Consensus Guidance Statement on the Management and Treatment of IgG4-Related Disease. Arthritis Rheumatol. 2015 Jul;67(7):1688-99. doi: 10.1002/art.39132. No abstract available.
- Background: PubMed 30124952Yunyun F, Yu P, Panpan Z, Xia Z, Linyi P, Jiaxin Z, Li Z, Shangzhu Z, Jinjing L, Di W, Yamin L, Xiaowei L, Huadan X, Xuan Z, Xiaofeng Z, Fengchun Z, Yan Z, Wen Z. Efficacy and safety of low dose Mycophenolate mofetil treatment for immunoglobulin G4-related disease: a randomized clinical trial. Rheumatology (Oxford). 2019 Jan 1;58(1):52-60. doi: 10.1093/rheumatology/key227.
- Background: PubMed 31121062Peng Y, Li JQ, Zhang PP, Zhang X, Peng LY, Chen H, Zhou JX, Zhang SZ, Yang HX, Liu JJ, Guo HF, Li J, Zhang X, Zhao Y, Zeng XF, Zhang FC, Fei YY, Zhang W. Clinical outcomes and predictive relapse factors of IgG4-related disease following treatment: a long-term cohort study. J Intern Med. 2019 Nov;286(5):542-552. doi: 10.1111/joim.12942. Epub 2019 Jun 17.
- Background: PubMed 35419810Liu Z, Peng Y, Li J, Lu H, Peng L, Zhou J, Zhou S, Huang C, Wang M, Zhu L, Chen H, Wang L, Fei Y, Zhao Y, Zeng X, Zhang W. Prediction of new organ onset in recurrent immunoglobulin G4-related disease during 10 years of follow-up. J Intern Med. 2022 Jul;292(1):91-102. doi: 10.1111/joim.13477. Epub 2022 Apr 13.
- Derived from this study: PubMed 42731845Zhang J, Nie Y, Peng L, Fei Y, Liu Y, Dong L, Kong X, Fu M, Zhang X, Liu C, Chen Y, Li M, Zhou J, Zhang W. Efficacy and safety of mycophenolate mofetil in preventing relapse of IgG4-related disease with re-elevation of serum IgG4 level during maintenance therapy: a protocol for a multicentre, randomised, double-blind, placebo-controlled study in China. BMJ Open. 2026 Sep 11;16(9):e113850. doi: 10.1136/bmjopen-2025-113850.
- Individual participant dataSharing planned: Yes
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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.
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 mycophenolate mofetil in people with Autoimmune Diseases, run by Peking Union Medical College 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 7 inclusion and 21 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 3 Aug 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 Jiaxin Zhou, MD (86-10-69155647, pumczhou@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of relapse rate of IgG4-RD between two groups in week 52. (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05974683, which also lists 9 linked publications.
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 3 Aug 2023.