IgG4-related DiseaseNCT06663618
Short-term Glucocorticoid Combined with MMF for IgG4-RD
A study testing prednison and Mycophenolate mofetil in people with IgG4-related Disease, run by Wen Zhang at 1 site in China.
Trial summary
Comparison of short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- IgG4-related Disease
- What is being tested?
- prednison and Mycophenolate mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old;
- All patients must meet the comprehensive diagnostic criteria of IgG4-RD revised in Japan in 2020 or the classification criteria of IgG4-RD formulated by ACR/EULAR in 2019;
- Active IgG4-RD (at least one organ has an IgG4-RD reaction score >=2 at the time of enrollment.)；
- No previous medication or recurrence after withdrawal.
Who cannot join
- Combined with other autoimmune diseases as the main diagnosis.
- Pregnant or lactating women
- Patients with malignant tumor
- Active bacterial, fungal, viral or mycobacterial infections.
- Severe complications of important organs, and the expected survival time is less than 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100050
Linyi Peng, MD, 8615810395901, drpenglinyi@163.com
Wen Zhang, MD
About this study
Official title: Comparison of Short-term Glucocorticoid Monotherapy and Short-term Glucocorticoid Combined with Mycophenolate Mofetil in the Treatment of IgG4 Related Disease
Comparison of short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease
Read the detailed description
This is a monocenter, 72-week prospective, randomized controlled study to compare short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease.
- Conditions
- IgG4-related Disease
- Being tested
- prednison, Mycophenolate mofetil
- Keywords
- IgG4-related disease
- 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.
prednisonDrug
Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months.
Oral Mycophenolate mofetil 0.75g bid for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| short-term glucocorticoid monotherapy | Placebo comparator | Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. Receives: Drug: prednison |
| short-term glucocorticoid combined with Mycophenolate mofetil | Experimental | Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. Oral Mycophenolate mofetil 0.75g bid for 6 months. Receives: Drug: prednison; Drug: Mycophenolate mofetil |
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 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels.
Measured: 72 weeks
Secondary outcomes (6)
The time of recurrence
Clinical recurrence definition: any item of IgG4-RD Responder Index >=2 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels.
Measured: 0-72 weeks
The changes of IgG4-related disease Responder Index
According to international multispecialty validation study of IgG4-related disease Responder Index (November, 2018), Responder Index ≥ 0, and higher scores mean a worse outcome.
Measured: 72 weeks
The changes of serum IgG4 levels
Level of serum IgG4(mg/dL)
Measured: 72 weeks
The percentages of adverse events
Adverse effect of drugs
Measured: 72 weeks
The changes of PGA
Changes of patient global assessment from baseline, score (0-10, higher is worse)
Measured: 72 weeks
The difference of remission rate of IgG4-RD between the two groups
Including complete remission rate, partial remission rate and total response rate.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Sep 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Sep 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 DiseaseStudies 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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen Zhang
- Sponsor type
- University, hospital or other
- 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
- NCT06663618
- Sponsor's protocol ID
- MMF for IgG4-RD
- Status last verified
- Sep 2024
- First submitted
- 23 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short-term Glucocorticoid Monotherapy and Short-term Glucocorticoid Combined with Mycophenolate Mofetil in the Treatment of IgG4 Related Disease
- ClinicalTrials.gov ID
- NCT06663618
- Acronym / sponsor ID
- MMF for IgG4-RD
- Conditions
- IgG4-related Disease
- Keywords
- IgG4-related disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Wen ZhangUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 29 Oct 2024 (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.
Comparison of short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease
Detailed description
This is a monocenter, 72-week prospective, randomized controlled study to compare short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short-term glucocorticoid monotherapy | Placebo comparator | Drug: prednisonOral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. |
| short-term glucocorticoid combined with Mycophenolate mofetil | Experimental | Drug: prednison, Drug: Mycophenolate mofetilOral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. Oral Mycophenolate mofetil 0.75g bid for 6 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-80 years old;
- All patients must meet the comprehensive diagnostic criteria of IgG4-RD revised in Japan in 2020 or the classification criteria of IgG4-RD formulated by ACR/EULAR in 2019;
- Active IgG4-RD (at least one organ has an IgG4-RD reaction score >=2 at the time of enrollment.)；
- No previous medication or recurrence after withdrawal.
Key exclusion criteria (5 listed)
- Combined with other autoimmune diseases as the main diagnosis.
- Pregnant or lactating women
- Patients with malignant tumor
- Active bacterial, fungal, viral or mycobacterial infections.
- Severe complications of important organs, and the expected survival time is less than 6 months.
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 |
|---|---|---|
| prednisonOral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. | Drug | short-term glucocorticoid combined with Mycophenolate mofetil, short-term glucocorticoid monotherapy |
| Mycophenolate mofetilOral Mycophenolate mofetil 0.75g bid for 6 months. | Drug | short-term glucocorticoid combined with Mycophenolate mofetil |
Primary outcome
The difference of recurrent rate of IgG4-RD between the two groups
Time frame: 72 weeks
Clinical recurrence definition: any item of IgG4-RD Responder Index >=2 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels.
6 secondary outcomes
The time of recurrence
Time frame: 0-72 weeks
The changes of IgG4-related disease Responder Index
Time frame: 72 weeks
The changes of serum IgG4 levels
Time frame: 72 weeks
The percentages of adverse events
Time frame: 72 weeks
The changes of PGA
Time frame: 72 weeks
The difference of remission rate of IgG4-RD between the two groups
Time frame: 72 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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 prednison and Mycophenolate mofetil in people with IgG4-related Disease, 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 5 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 29 Oct 2024. 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: 72 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 29 Oct 2024.