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

Withdraw Drug in Stable IgG4-Related Disease

Sponsors

Lead sponsor: Peking Union Medical College Hospital

Collaborator: Chinese PLA General Hospital
Peking University People's Hospital
The People's Hospital of Hebei Province
Shengjing Hospital
Tongji Hospital

Source Peking Union Medical College Hospital
Brief 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.

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.

Overall Status Not yet recruiting
Start Date October 15, 2019
Completion Date October 15, 2022
Primary Completion Date April 15, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent of recurrence of IgG4-RD. One and half year
Secondary Outcome
Measure Time Frame
IgG4-RD Responder Index One and half year
Serum IgG4 level One and half year
Serum IgG level One and half year
Serum hsCRP level One and half year
ESR One and half year
Adverse effect One and half year
Enrollment 138
Condition
Intervention

Intervention type: Drug

Intervention name: Drug free, IS monotherapy and GC combined with IS

Description: Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Wen Zhang, MD. Principal Investigator Peking Union Medical College Hospital
Overall Contact

Last name: linyi peng, MD.

Phone: +8615810395901

Email: [email protected]

Verification Date

October 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Peking Union Medical College Hospital

Investigator full name: Wen Zhang

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Drug free

Arm group type: Experimental

Description: Drug:free Glucocorticoid(GC)is tapered and stopped in 8 weeks. Immunosuppressant treatment is also stopped after admission.

Arm group label: IS monotherapy

Arm group type: Experimental

Description: Drug: Immunosuppressant 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 (<=12.5mg/w) or Azathioprine (<=100mg/d)

Arm group label: GC combined with IS

Arm group type: Experimental

Description: Drug: GC+Immunosuppressant Both Glucocorticoid(GC) (no more than 7.5mg/d) and immunosuppressant are kept as maintaining dose.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov