Study of Treatment Response on IgG4 Related Disease (IgG4RD)

Autoimmune Disease Clinical Trial

Official title:

A Randomized Trial of Treatment in Patients With IgG4-Related Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02458196
• Other study ID #: IgG4-02
• Status: Recruiting
• Phase: Phase 2
• First received: April 15, 2015
• Last updated: January 23, 2017
• Start date: April 2015
• Est. completion date: June 2018

Study information

• Verified date: December 2016
• Source: Peking Union Medical College Hospital
• Contact: Wen Zhang, Professor
• Phone: 861069158795
• Email: zhangwen91[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Autoimmune Disease
• Autoimmune Diseases

Intervention

Drug:
• Prednisone
Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 10mg/d to 12 months.
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete and partial response rate at 3, 6, 9 and 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	Up to 12 months
Secondary	Disease response at 3, 6, 9 and 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.	Up to 12 months
Secondary	Number of participants with adverse effect	Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.	Up to 12 months