Status:
UNKNOWN
Withdraw Drug in Stable IgG4-Related Disease
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Chinese PLA General Hospital
Peking University People's Hospital
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
18-70 years
Phase:
NA
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 l...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04124861
Start Date
June 23 2020
End Date
June 30 2023
Last Update
February 7 2022
Active Locations (1)
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1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050