Study of Treatment Response on IgG4 Related Disease (IgG4RD)

January 23, 2017 updated by: Wen Zhang, Peking Union Medical College Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.
Other Names:
  • Prednisolone
  • Pred
EXPERIMENTAL: 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.
Drug: 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.

Other Names:
  • MMF
  • Mycophenolate mofetil Dispersible Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete and partial response rate at 3, 6, 9 and 12 months.
Time Frame: 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
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease response at 3, 6, 9 and 12 months.
Time Frame: 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.
Up to 12 months
Number of participants with adverse effect
Time Frame: Up to 12 months
Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.
Up to 12 months

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Wen Zhang, Professor, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (ESTIMATE)

June 1, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IgG4-02

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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