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Study of Treatment Response on IgG4 Related Disease (IgG4RD)

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ClinicalTrials.gov Identifier: NCT02458196
Recruitment Status : Unknown
Verified December 2016 by Wen Zhang, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : June 1, 2015
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Wen Zhang, Peking Union Medical College Hospital

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
Autoimmune Disease Drug: Prednisone Drug: Prednisone and Mycophenolate mofetil 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Number of participants with adverse effect [ Time Frame: Up to 12 months ]
    Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458196


Contacts
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Contact: Wen Zhang, Professor 861069158795 zhangwen91@sina.com
Contact: Yunyun Fei, Doctor 861069158797 feiyunyun2013@hotmail.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Xuan Zhang, Professor    861069155821    zxpumch2003@sina.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Wen Zhang, Professor Peking Union Medical College Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wen Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02458196    
Other Study ID Numbers: IgG4-02
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: December 2016
Keywords provided by Wen Zhang, Peking Union Medical College Hospital:
IgG4 related disease
IgG4-RD
Response rate
Relapse
Additional relevant MeSH terms:
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Autoimmune Diseases
Immunoglobulin G4-Related Disease
Immune System Diseases
Mycophenolic Acid
Prednisone
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action