Study of Treatment Response on IgG4 Related Disease (IgG4RD)

Phase 2

• Conditions: Autoimmune Disease
• Interventions: Drug: Prednisone and Mycophenolate mofetil; Drug: Prednisone

• Registration Number: NCT02458196
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This is an open-label randomized controlled trial to compare the efficacy of Prednisone alone and combination therapy of Prednisone and Mycophenolate mofetil in IgG4RD patients.

Detailed Description

Patients with IgG4-RD will be randomized in two therapeutic groups: Prednisone alone and combination therapy with Prednisone and Mycophenolate mofetil. These patients will be followed in 12 months. Treatment response and relapse will be recorded, as well as side effects.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-06-01
• Status Verified: 2016-12
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24
• Primary Completion: 2017-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Males and females

• Aged 18 to 70 years old with informed consent

• 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;
  4. exclusion of other diseases.

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Exclusion Criteria

• Patients will not be included if meets any of the following criteria:

  1. Patients who were diagnosed as other autoimmune diseases;
  2. Patients who were diagnosed as malignant diseases;
  3. Pregnant and lactating women；
  4. Active infection: HIV, HCV, HBV, TB；
  5. Serious organ function failure, expected life time less than 6 months.
  6. Presenting with Mikulicz disease without other manifestations.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone and Mycophenolate mofetil	Prednisone and Mycophenolate mofetil	Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months. Immunosuppressive drugs: Mycophenolate mofetil 1g/d-1.5g/d for 6 months and 0.5/d-1.0g/d for 6 months.
Prednisone	Prednisone	Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.

Primary Outcome Measures

Name	Time	Method
Complete and partial response rate at 3, 6, 9 and 12 months.	Up to 12 months	Complete and partial response are defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse effect	Up to 12 months	Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.
Disease response at 3, 6, 9 and 12 months.	Up to 12 months	Disease response is measured by IgG4-RD Responder Index(IgG4-RD RI) and defined as: * Improvement of \>2 points in the IgG4-RD RI over baseline; * No disease flares, as assessed by the IgG4-RD RI.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China