Withdraw Drug in Stable IgG4-Related Disease

Autoimmune Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04124861
• Other study ID #: Withdraw drug in IgG4-RD
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2022
• Source: Peking Union Medical College Hospital
• Contact: linyi peng, MD.
• Phone: +8615810395901
• Email: drpenglinyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Disease stabilized more than one year (Responder Index < 2 points)

3. Dose of Glucocorticoid(GC): prednisone (or equivalent) = 7.5mg/d for more than 6 months

4. 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).

Exclusion Criteria:

1. Patient was diagnosed other connective tissue diseases

2. Patient with tumor

3. Women during pregnancy or planning pregnancy

4. Patient with active infections, including HIV, HCV, HBV, TB, etc.

5. Patient with severe irreversible organ damage

6. Active IgG4-RD, responder index >= 2 points

7. Stable condition less than one year.

8. Patient with two or more immunosuppressive agents.

9. Biological agents (such as CD20 monoclonal antibody and TNF-a inhibitor) have been used for half a year before admission.

10. Patient with IgG4-RD recurrence during hormone reduction in the past.

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

Drug:
• Drug free, IS monotherapy and GC combined with IS
Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Chinese PLA General Hospital, Peking University People's Hospital, Shengjing Hospital, The People's Hospital of Hebei Province, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One and half year
Secondary	The changes of IgG4-RD Responder Index	According to IgG4-RD responder Index Validation Study (Version: 13, December, 2015)	One and half year
Secondary	The changes of serum IgG4 levels	Level of serum IgG4(mg/dL)	One and half year
Secondary	The changes of serum IgG level	Level of serum IgG(g/L)	One and half year
Secondary	The changes of serum hsCRP level	Level of serum high-sensitivity C-reactive protein level(mg/L)	One and half year
Secondary	The changes of ESR	Serum erythrocyte sedimentation rate(mm/h)	One and half year
Secondary	The percentages of adverse events	Adverse effect of drugs	One and half year