Study of Treatment Response on IgG4 Related Disease (IgG4RD)

NCT02458196 | Unknown Phase 2 DMC

• 1 other identifier: IgG4-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Disease

Keywords

IgG4 related disease; IgG4-RD; Response rate; Relapse

Outcome Measures

Primary Outcomes (1)

• Complete and partial response rate at 3, 6, 9 and 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 Outcomes (2)

• Disease response at 3, 6, 9 and 12 months.

  Up to 12 months

• Number of participants with adverse effect

  Up to 12 months

Study Arms (2)

Prednisone

EXPERIMENTAL

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 and Mycophenolate mofetil

EXPERIMENTAL

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

Interventions

Prednisone DRUG

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.

Also known as: Pred, Prednisolone

Prednisone

Prednisone and Mycophenolate mofetil DRUG

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.

Also known as: MMF, Mycophenolate mofetil Dispersible Tablets

Prednisone and Mycophenolate mofetil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• Aged 18 to 70 years old with informed consent
• All patients must meet the following diagnostic criteria of IgG4RD (2011):
• 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;
• elevated serum IgG4 (\>1.35 g/L);
• 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;

You may not qualify if:

• Patients will not be included if meets any of the following criteria:
• Patients who were diagnosed as other autoimmune diseases;
• Patients who were diagnosed as malignant diseases;
• Pregnant and lactating women；
• Active infection: HIV, HCV, HBV, TB；
• Serious organ function failure, expected life time less than 6 months.
• Presenting with Mikulicz disease without other manifestations.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• Yunyun F, Yu P, Panpan Z, Xia Z, Linyi P, Jiaxin Z, Li Z, Shangzhu Z, Jinjing L, Di W, Yamin L, Xiaowei L, Huadan X, Xuan Z, Xiaofeng Z, Fengchun Z, Yan Z, Wen Z. Efficacy and safety of low dose Mycophenolate mofetil treatment for immunoglobulin G4-related disease: a randomized clinical trial. Rheumatology (Oxford). 2019 Jan 1;58(1):52-60. doi: 10.1093/rheumatology/key227.

  PMID: 30124952 DERIVED

MeSH Terms

Conditions

Autoimmune Diseases; Immunoglobulin G4-Related Disease; Recurrence

Interventions

Prednisone; prednylidene; Prednisolone; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Wen Zhang, Professor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Zhang, Professor

CONTACT

861069158795; zhangwen91@sina.com

Yunyun Fei, Doctor

CONTACT

861069158797; feiyunyun2013@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: June 1, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: January 24, 2017

Record last verified: 2016-12

Locations

CN (1)