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Leflunomide Treatment for IgG4-RD

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ClinicalTrials.gov Identifier: NCT03715699
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Wen Zhang, Peking Union Medical College Hospital

Brief Summary:
This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.

Condition or disease Intervention/treatment Phase
Autoimmune Disease Drug: Prednisone Drug: Prednisone and Leflunomide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Leflunomide Treatment for IgG4-RD
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Patients treated with single glucocorticoid
Drug: Prednisone
Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 7.5mg to 10mg/d to 12 months.

Drug: Prednisone and Leflunomide

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.

Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months.


Experimental: Group 2
Patients treated with Leflunomide and glucocorticoid
Drug: Prednisone
Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 7.5mg to 10mg/d to 12 months.

Drug: Prednisone and Leflunomide

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.

Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months.





Primary Outcome Measures :
  1. Response of Leflunomide treatment for IgG4-RD [ Time Frame: 1 year ]
    Complete response rate; Partial response rate; No response


Secondary Outcome Measures :
  1. Relapse of Leflunomide treatment for IgG4-RD [ Time Frame: 1 year ]
    Clinical relapse; Serological relapse



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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): NCT03715699


Contacts
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Contact: Yunyun FEI +8613681125226 feiyunyun2013@hotmail.com

Locations
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China, Beijing
Yunyun Fei Recruiting
Beijing, Beijing, China, 100032
Contact: Yunyun Fei    +8613681125226    feiyunyun2013@hotmail.com   
Sponsors and Collaborators
Peking Union Medical College Hospital

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Responsible Party: Wen Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03715699     History of Changes
Other Study ID Numbers: Treatment for IgG4-RD
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases
Prednisone
Leflunomide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors