Leflunomide Treatment for IgG4-RD

October 21, 2018 updated by: Wen Zhang, Peking Union Medical College Hospital
This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Yunyun Fei

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Patients treated with single glucocorticoid
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.
Drug: 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.
Experimental: Group 2
Patients treated with Leflunomide and glucocorticoid
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response of Leflunomide treatment for IgG4-RD
Time Frame: 1 year
Complete response rate; Partial response rate; No response
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse of Leflunomide treatment for IgG4-RD
Time Frame: 1 year
Clinical relapse; Serological relapse
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

October 21, 2018

First Posted (Actual)

October 23, 2018

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 21, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Treatment for IgG4-RD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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