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Glucocorticoids in Patients With IgG4-RD

This study is currently recruiting participants.
Verified December 2012 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Wen Zhang, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01758393
First received: December 24, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

This is a randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related Disease. Patients will be followed for three months to measure the primary outcome and secondary outcomes.


Condition Intervention Phase
IgG4-related Disease
 Drug: Prednisone
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease

Resource links provided by NLM:

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone
U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Complete Response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Complete Response(CR) is defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies.


Secondary Outcome Measures:
  • Disease Response [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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.

  • Adverse Effect [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medium Dose
Patients are treated with prednisone or equivlent at doseage of 0.5-0.6 mg/kg/d (max 40mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.
 Drug: Prednisone
Experimental: High Dose
Patients are treated with prednisone or equivlent at doseage of 0.8-1.0 mg/kg/d (max 60mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.
 Drug: Prednisone

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females
  • Age 18-70 years old with informed consent

  • Patients with IgG4-RD:

    1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, 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);
    4. exclusion of other diseases.

Exclusion Criteria:

  • Previously or currently received glucocorticoid and(or) immunomodulator
  • Pregnancy or lactating
  • Concurrent severe and/or uncontrolled and/or unstable diseases
  • Patient with malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758393

Contacts
Contact: Hua Chen, MD +86-10-69158797 chenhua@pumch.cn

Locations
China, Beijing
Deptment of Rheumatology, Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100032
Contact: Wen Zhang, MD     +86-10-69158795     zhangwen91@sina.com    
Contact: Hua Chen, MD     +86-10-69158797     chenhua@pumch.cn    
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Wen Zhang, MD Deptment of Rheumatology, Peking Union Medical College Hospital
Study Chair: Fengchun Zhang Deptment of Rheumatology, Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Wen Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01758393     History of Changes
Other Study ID Numbers: PUMCH-GC-IgG4RD
Study First Received: December 24, 2012
Last Updated: December 24, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Peking Union Medical College Hospital:
IgG4-related disease
IgG4-RD

Additional relevant MeSH terms:
Glucocorticoids
Prednisone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013