Clincosm LogoSign in Get a demo

Study of Treatment Response on IgG4 Related Disease (IgG4RD)

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02458196
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
38
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of Treatment in Patients With IgG4-Related Disease
Study Start Date :
Apr 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

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:
  • Pred
  • Prednisolone

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complete and partial response rate at 3, 6, 9 and 12 months. [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

    Secondary Outcome Measures

    1. Disease response at 3, 6, 9 and 12 months. [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.

    2. Number of participants with adverse effect [Up to 12 months]

      Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wen Zhang, Professor, Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT02458196
    Other Study ID Numbers:
    • IgG4-02
    First Posted:
    Jun 1, 2015
    Last Update Posted:
    Jan 24, 2017
    Last Verified:
    Dec 1, 2016
    Keywords provided by Wen Zhang, Professor, Peking Union Medical College Hospital
    IgG4 related disease
    IgG4-RD
    Response rate
    Relapse
    Additional relevant MeSH terms:
    Autoimmune Diseases
    Immunoglobulin G4-Related Disease
    Mycophenolic Acid
    Prednisone
    Prednisolone

    Study Results

    No Results Posted as of Jan 24, 2017