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Trial record 91 of 92 for:    Primary Sclerosing Cholangitis

Leflunomide for Maintenance of Remission in IgG4 Related Disease

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ClinicalTrials.gov Identifier: NCT02703194
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Jian Zhu, Chinese PLA General Hospital

Brief Summary:
The study has been designed as a 12-month, open-label, randomized, controlled study comparing the use of prednisone mono-therapy and prednisone and leflunomide combination therapy in treating patients with IgG4-related disease.

Condition or disease Intervention/treatment Phase
Immunoglobulin G4 Related Sclerosing Disease Drug: Prednisone Drug: Leflunomide Phase 4

Detailed Description:
The aim of this clinical trial is to determine the safety and efficacy of Leflunomide in treating patients with IgG4-related disease by comparing the outcomes of prednisone and leflunomide combination therapy with prednisone mono-therapy. The follow-up period will be 12 months. During the follow-up period, results of laboratory tests and image examinations, IgG4-RD RI and other parameters which can reflect treatment response as well as adverse effect events will be recorded.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease
Actual Study Start Date : March 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019


Arm Intervention/treatment
Experimental: Prednisone
Prednisone mono-therapy
Drug: Prednisone
Prednisone:A starting dose of 0. 5-0. 8mg/(kg*d) will be given. Following four-week period, the dose will be tapered gradually to 5mg/d until the end of 12 months of follow-up period.
Other Name: Prednisolone

Experimental: Prednisone and Leflunomide
Prednisone and Leflunomide combination therapy
Drug: Prednisone
Prednisone:A starting dose of 0. 5-0. 8mg/(kg*d) will be given. Following four-week period, the dose will be tapered gradually to 5mg/d until the end of 12 months of follow-up period.
Other Name: Prednisolone

Drug: Leflunomide
Leflunomide:A starting dose of 20 mg/day will be given. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor adverse effects occur(e.g., liver enzyme elevations).
Other Name: ARAVA®




Primary Outcome Measures :
  1. Relapse rate at 12 months. [ Time Frame: 12 months ]
    Relapse referred to the recurrence of previous clinical manifestations or abnormality of organ-specific imaging findings or serology tests after remission.


Secondary Outcome Measures :
  1. Relapse rate at 6 months. [ Time Frame: 6 months ]
    Relapse referred to the recurrence of previous clinical manifestations or abnormality of organ-specific imaging findings or serology tests after remission.

  2. Complete response assessed by IgG4-RD Responder Index (IgG4-RD RI) at 1, 3, 6 and 12 months. [ Time Frame: Up to 12 months ]
    Complete response (CR) is defined as IgG4-RD RI <3 at 1, 3, 6 and 12 months.

  3. Partial response assessed by IgG4-RD RI at 1, 3, 6 and 12 months. [ Time Frame: Up to 12 months ]
    Partial response (PR) is defined as IgG4-RD RI remaining ≥3 at 1, 3, 6 and 12 months.

  4. Serum IgG4 concentrations (mg/dL) measured by immunonephelometry at 1, 3, 6 and 12 months. [ Time Frame: Up to 12 months ]
  5. Number of circulating plasmablasts (cell number/mL) assessed by flow cytometry by gating peripheral blood at 1, 3, 6 and 12 months. [ Time Frame: Up to 12 months ]
  6. Adverse effect events [ Time Frame: Up to 12 months ]
    Treatment-related adverse effect, including abnormal liver function and leukopenia.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 80 years.
  2. Diagnosis of IgG4-RD according to either Consensus statement on the pathology of IgG4-related disease (for those who have undergone biopsies) or 2011 Comprehensive diagnostic criteria for IgG4-related disease. Both of the two criteria for diagnosis are specified below.

(1)Consensus statement on the pathology of IgG4-related disease

  1. Histopathologic features consisting of dense lymphoplasmacytic infiltrate, fibrosis(usually storiform in character)and/or obliterative phlebitis within involved organs.
  2. Either an elevated IgG4+/IgG+cell ratio of >40% within the affected organs or elevated IgG4-bearing plasma cells per high-power field is necessary. The cut-off number of IgG4-bearing plasma cells per high-power field is different depending upon the types of affected organs and specimens(through surgery or needle puncture biopsy).

(2)2011 Comprehensive diagnostic criteria for IgG4-related disease

  1. Clinical examination showing characteristic diffuse/localized swelling or masses in single or multiple organs.
  2. Hematological examination shows elevated serum IgG4 concentrations(135 mg/dl).
  3. Histopathologic examination shows marked lymphocyte and plasmacyte infiltration and fibrosis or Infiltration of IgG4+ plasma cells(ratio of IgG4+/IgG+ cells > 40% and >10 IgG4+ plasma cells/HPF).

    Definite: a + b + c,Probable: a + c,Possible: a + b

  4. Excluded from malignant tumors of each organ (e.g. cancer, lymphoma) and similar diseases (e.g. Sjögren's syndrome, primary sclerosing cholangitis, Castleman's disease, secondary retroperitoneal fibrosis, Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome) by additional histopathological examination.
  5. Even when patients cannot be diagnosed using the Comprehensive diagnostic criteria, they may be diagnosed using organ-specific diagnostic criteria for IgG4-RD, such as Diagnostic criteria for IgG4-Mikulicz's disease.

Exclusion Criteria:

  1. Subjects having received steroids or immunosuppressants in recent 3 months will be excluded.
  2. Subjects who were hypersensitive to leflunomide will be excluded.
  3. ALT and/or AST is more than two folds of the upper limit of relevant reference value at baseline.
  4. WBC is less than 3×10*9/L at baseline.
  5. Female patients who are pregnant or breastfeeding.
  6. Known significant concurrent medical disease.

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): NCT02703194


Locations
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China
Chinese PLA General Hospital
Beijing, China, 100000
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Jian Zhu Chinese PLA General Hospital

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Responsible Party: Jian Zhu, Deputy Director of Rheumatology, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02703194     History of Changes
Other Study ID Numbers: ChinaPLAGH-IgG4
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Keywords provided by Jian Zhu, Chinese PLA General Hospital:
IgG4-related disease
IgG4-related sclerosing cholangitis
Mikulicz disease
Pancreatitis
Retroperitoneal fibrosis
Lymphadenopathy
Additional relevant MeSH terms:
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Immunoglobulin G4-Related Disease
Autoimmune Diseases
Immune System Diseases
Prednisone
Leflunomide
Immunoglobulin G
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