Leflunomide Treatment for IgG4-RD

Autoimmune Disease Clinical Trial

Official title:

Leflunomide Treatment for IgG4-RD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03715699
• Other study ID #: Treatment for IgG4-RD
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2018
• Source: Peking Union Medical College Hospital
• Contact: Yunyun FEI
• Phone: +8613681125226
• Email: feiyunyun2013[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• 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 7.5mg to 10mg/d to 12 months.
• Prednisone and Leflunomide
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. Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months.

Locations

Country	Name	City	State
China	Yunyun Fei	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	Response of Leflunomide treatment for IgG4-RD	Complete response rate; Partial response rate; No response	1 year
Secondary	Relapse of Leflunomide treatment for IgG4-RD	Clinical relapse; Serological relapse	1 year