Study of Treatment Response on IgG4 Related Disease (IgG4RD)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02458196
• Date of registration: 15/04/2015
• Prospective Registration: No
• Primary sponsor: Peking Union Medical College Hospital
• Public title: Study of Treatment Response on IgG4 Related Disease (IgG4RD)
• Scientific title: A Randomized Trial of Treatment in Patients With IgG4-Related Disease
• Date of first enrolment: April 2015
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02458196
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Wen Zhang, Professor
• Affiliation: Peking Union Medical College Hospital

• Name: Xuan Zhang, Professor

• Name: Wen Zhang, Professor

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Autoimmune Disease

Intervention(s)

Drug: Prednisone and Mycophenolate mofetil

Drug: Prednisone

Primary Outcome(s)

Complete and partial response rate at 3, 6, 9 and 12 months. [Time Frame: Up to 12 months]

Secondary Outcome(s)

Number of participants with adverse effect [Time Frame: Up to 12 months]

Disease response at 3, 6, 9 and 12 months. [Time Frame: Up to 12 months]

Secondary ID(s)

IgG4-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors