Autoimmune DiseasesNCT04124861
Withdraw Drug in Stable IgG4-Related Disease
A study testing Drug free, IS monotherapy and GC combined with IS in people with Autoimmune Diseases, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Evaluation and prediction of relapse risk after glucocorticoid or immunosuppressant withdrawal in patients with stable IgG4 related disease: a prospective cohort study from china. 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?
- Drug free, IS monotherapy and GC combined with IS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2020to 30 Jun 2023
- 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
- All patients must meet the following diagnostic criteria of IgG4RD (2011): 1)Swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2)Elevated serum IgG4 (>1.35 g/L); 3)Histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD. exclusion of other diseases.
- Disease stabilized more than one year (Responder Index < 2 points)
- Dose of Glucocorticoid(GC): prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months
- Immunosuppressant: one of the following drugs, the same dose maintain at least 3 months (Mycophenolate mate <= 1g/d or Leflunomide <=20mg/d or Methotrexate <=12.5mg/w or Azathioprine <=100mg/d).
Who cannot join
- Patient was diagnosed other connective tissue diseases
- Patient with tumor
- Women during pregnancy or planning pregnancy
- Patient with active infections, including HIV, HCV, HBV, TB, etc.
- Patient with severe irreversible organ damage
- Active IgG4-RD, responder index >= 2 points
Show all 10Show fewer
- Stable condition less than one year.
- Patient with two or more immunosuppressive agents.
- Biological agents (such as CD20 monoclonal antibody and TNF-a inhibitor) have been used for half a year before admission.
- Patient with IgG4-RD recurrence during hormone reduction in the past.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Yanying Liu, MD, 13581746850, liuyanying20030801@msn.com
About this study
Official title: Evaluation and Prediction of Relapse Risk After Glucocorticoid and Immunosuppressant Withdrawal in Patients With Stable IgG4 Related Disease: An Open-labeled Multi-centric Randomized Controlled Study From China
Evaluation and prediction of relapse risk after glucocorticoid or immunosuppressant withdrawal in patients with stable IgG4 related disease: a prospective cohort study from china.
Read the detailed description
IgG4-related disease (IgG4-RD) is a chronic autoimmune disease with a relapsing-remitting course. For patients in remission, glucocorticoid (GC) and immunosuppressant are used to be maintained for a long time in fear of disease flare. Long-term GC and immunosuppressant could bring a lot of side-effects and economic burden. Whether and when patients with stable disease should withdraw GC or immunosuppressant? How about the relapse risk respectively? What are the risk factors for disease flare? All the above remain unclear. The aim of this study is to explore the relapse risk after GC or immunosuppressant withdrawal in IgG4-RD patients with stable disease and to establish a predictive model for risk stratification. Meanwhile the investigators aim to testify the effects of immunosuppressant in preventing IgG4-RD relapse. This study is a prospective cohort clinical trial.
- Conditions
- Autoimmune Diseases
- Being tested
- Drug free, IS monotherapy and GC combined with IS
- Keywords
- Immunoglobulin G4-Related Disease
- Medical subject headings
- Autoimmune Diseases, Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug free, IS monotherapy and GC combined with ISDrug
Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).
| Study group | Role | What they receive |
|---|---|---|
| Drug free | Experimental | Arm A: Drug free Glucocorticoid（GC）is tapered and stopped in 8 weeks(GCs at a dose of ≤ 2.5 mg of prednisone or equivalent for treatment of adrenal insufficiency) .
Immunosuppressant is also tapered and discontinues in 8 weeks. Receives: Drug: Drug free, IS monotherapy and GC combined with IS |
| IS monotherapy | Experimental | Arm B: Immunosuppressant only Glucocorticoid（GC）is tapered and stopped in 8 weeks. The same type and dosage of immunosuppressive agent before admission, including Mycophenolate mate(<= 1g/d) or Leflunomide (<=20mg/d) or Methotrexate (<=15mg/w) or Azathioprine (<=100mg/d) Receives: Drug: Drug free, IS monotherapy and GC combined with IS |
| GC combined with IS | Experimental | Arm C: GC+Immunosuppressant Both Glucocorticoid(GC) (no more than 7.5mg/d) and immunosuppressant are kept as maintaining dose. Receives: Drug: Drug free, IS monotherapy and GC combined with IS |
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 among three groups.
Clinical recurrence definition: any item of IgG4-RD Responder Index >=2，new organ involvement; with or without elevated serum IgG4 levels. Serum recurrence definition: Serum IgG4 level was higher than baseline level, IgG4-RD Responder Index was higher than or equal to 1 point, without clinical symptom or imaging deterioration.
Measured: One and half year
Secondary outcomes (6)
The changes of IgG4-RD Responder Index
According to IgG4-RD responder Index Validation Study (Version: 13, December, 2015)
Measured: One and half year
The changes of serum IgG4 levels
Level of serum IgG4(mg/dL)
Measured: One and half year
The changes of serum IgG level
Level of serum IgG(g/L)
Measured: One and half year
The changes of serum hsCRP level
Level of serum high-sensitivity C-reactive protein level(mg/L)
Measured: One and half year
The changes of ESR
Serum erythrocyte sedimentation rate(mm/h)
Measured: One and half year
The percentages of adverse events
Adverse effect of drugs
Measured: One and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start23 Jun 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Peking University People's Hospital, The People's Hospital of Hebei Province, Shengjing Hospital, Tongji Hospital
- Responsible party
- Principal investigator, Wen Zhang, Peking Union Medical College Hospital
- Investigators
- Wen Zhang, MD., Principal investigator, Peking Union Medical College HospitalYunyun Fei, MD, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124861
- Sponsor's protocol ID
- Withdraw drug in IgG4-RD
- Status last verified
- Jan 2022
- First submitted
- 13 Feb 2019
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peng L, Nie Y, Zhou J, Wu L, Chen X, Wang F, Li J, Peng Y, Lu H, Zhao L, Li M, Zhao Y, Zeng X, Fei Y, Zhang W. Withdrawal of immunosuppressants and low-dose steroids in patients with stable IgG4-RD (WInS IgG4-RD): an investigator-initiated, multicentre, open-label, randomised controlled trial. Ann Rheum Dis. 2024 Apr 11;83(5):651-660. doi: 10.1136/ard-2023-224487.
PubMed 38216319
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Prediction of Relapse Risk After Glucocorticoid and Immunosuppressant Withdrawal in Patients With Stable IgG4 Related Disease: An Open-labeled Multi-centric Randomized Controlled Study From China
- ClinicalTrials.gov ID
- NCT04124861
- Acronym / sponsor ID
- Withdraw drug in IgG4-RD
- Conditions
- Autoimmune Diseases
- Keywords
- Immunoglobulin G4-Related Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Peking University People's Hospital, The People's Hospital of Hebei Province, Shengjing Hospital, Tongji Hospital
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 11 Oct 2019 (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.
Evaluation and prediction of relapse risk after glucocorticoid or immunosuppressant withdrawal in patients with stable IgG4 related disease: a prospective cohort study from china.
Detailed description
IgG4-related disease (IgG4-RD) is a chronic autoimmune disease with a relapsing-remitting course. For patients in remission, glucocorticoid (GC) and immunosuppressant are used to be maintained for a long time in fear of disease flare. Long-term GC and immunosuppressant could bring a lot of side-effects and economic burden. Whether and when patients with stable disease should withdraw GC or immunosuppressant? How about the relapse risk respectively? What are the risk factors for disease flare? All the above remain unclear. The aim of this study is to explore the relapse risk after GC or immunosuppressant withdrawal in IgG4-RD patients with stable disease and to establish a predictive model for risk stratification. Meanwhile the investigators aim to testify the effects of immunosuppressant in preventing IgG4-RD relapse. This study is a prospective cohort clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug free | Experimental | Drug: Drug free, IS monotherapy and GC combined with ISArm A: Drug free Glucocorticoid（GC）is tapered and stopped in 8 weeks(GCs at a dose of ≤ 2.5 mg of prednisone or equivalent for treatment of adrenal insufficiency) . Immunosuppressant is also tapered and discontinues in 8 weeks. |
| IS monotherapy | Experimental | Drug: Drug free, IS monotherapy and GC combined with ISArm B: Immunosuppressant only Glucocorticoid（GC）is tapered and stopped in 8 weeks. The same type and dosage of immunosuppressive agent before admission, including Mycophenolate mate(<= 1g/d) or Leflunomide (<=20mg/d) or Methotrexate (<=15mg/w) or Azathioprine (<=100mg/d) |
| GC combined with IS | Experimental | Drug: Drug free, IS monotherapy and GC combined with ISArm C: GC+Immunosuppressant Both Glucocorticoid(GC) (no more than 7.5mg/d) and immunosuppressant are kept as maintaining dose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients must meet the following diagnostic criteria of IgG4RD (2011): 1)Swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2)Elevated serum IgG4 (>1.35 g/L); 3)Histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD. exclusion of other diseases.
- Disease stabilized more than one year (Responder Index < 2 points)
- Dose of Glucocorticoid(GC): prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months
- Immunosuppressant: one of the following drugs, the same dose maintain at least 3 months (Mycophenolate mate <= 1g/d or Leflunomide <=20mg/d or Methotrexate <=12.5mg/w or Azathioprine <=100mg/d).
Key exclusion criteria (10 listed)
- Patient was diagnosed other connective tissue diseases
- Patient with tumor
- Women during pregnancy or planning pregnancy
- Patient with active infections, including HIV, HCV, HBV, TB, etc.
- Patient with severe irreversible organ damage
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 |
|---|---|---|
| Drug free, IS monotherapy and GC combined with ISFollow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month). | Drug | Drug free, GC combined with IS, IS monotherapy |
Primary outcome
The difference of recurrent rate of IgG4-RD among three groups.
Time frame: One and half year
Clinical recurrence definition: any item of IgG4-RD Responder Index >=2，new organ involvement; with or without elevated serum IgG4 levels. Serum recurrence definition: Serum IgG4 level was higher than baseline level, IgG4-RD Responder Index was higher than or equal to 1 point, without clinical symptom or imaging deterioration.
6 secondary outcomes
The changes of IgG4-RD Responder Index
Time frame: One and half year
The changes of serum IgG4 levels
Time frame: One and half year
The changes of serum IgG level
Time frame: One and half year
The changes of serum hsCRP level
Time frame: One and half year
The changes of ESR
Time frame: One and half year
The percentages of adverse events
Time frame: One and half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Derived from this study: PubMed 38216319Peng L, Nie Y, Zhou J, Wu L, Chen X, Wang F, Li J, Peng Y, Lu H, Zhao L, Li M, Zhao Y, Zeng X, Fei Y, Zhang W. Withdrawal of immunosuppressants and low-dose steroids in patients with stable IgG4-RD (WInS IgG4-RD): an investigator-initiated, multicentre, open-label, randomised controlled trial. Ann Rheum Dis. 2024 Apr 11;83(5):651-660. doi: 10.1136/ard-2023-224487.
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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
Yunyun Fei, MD study director
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 Drug free, IS monotherapy and GC combined with IS 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 4 inclusion and 10 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 7 Feb 2022. 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. 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 among three groups. (time frame: One and half year). 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 NCT04124861, which also lists 1 linked publication.
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 7 Feb 2022.