Leflunomide Treatment for IgG4-RD

Not Applicable

• Conditions: Autoimmune Disease
• Interventions: Drug: Prednisone; Drug: Prednisone and Leflunomide

• Registration Number: NCT03715699
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-09-25
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-21
• Last Update Submitted: 2018-10-21
• Study First Posted: 2018-10-23
• Last Update Posted: 2018-10-23
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Prednisone and Leflunomide	Patients treated with single glucocorticoid
Group 2	Prednisone and Leflunomide	Patients treated with Leflunomide and glucocorticoid
Group 1	Prednisone	Patients treated with single glucocorticoid
Group 2	Prednisone	Patients treated with Leflunomide and glucocorticoid

Primary Outcome Measures

Name	Time	Method
Response of Leflunomide treatment for IgG4-RD	1 year	Complete response rate; Partial response rate; No response

Secondary Outcome Measures

Name	Time	Method
Relapse of Leflunomide treatment for IgG4-RD	1 year	Clinical relapse; Serological relapse

Trial Locations

Locations (1)

Yunyun Fei; 🇨🇳 Beijing, Beijing, China