A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease
Overview
- Phase
- Phase 4
- Intervention
- Prednisone
- Conditions
- Immunoglobulin G4 Related Sclerosing Disease
- Sponsor
- Chinese PLA General Hospital
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Relapse rate at 12 months.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
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.
Investigators
Jian Zhu
Deputy Director of Rheumatology
Chinese PLA General Hospital
Eligibility Criteria
Inclusion Criteria
- •Age between 18 and 80 years.
- •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
- •Histopathologic features consisting of dense lymphoplasmacytic infiltrate, fibrosis(usually storiform in character)and/or obliterative phlebitis within involved organs.
- •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
- •Clinical examination showing characteristic diffuse/localized swelling or masses in single or multiple organs.
- •Hematological examination shows elevated serum IgG4 concentrations(135 mg/dl).
- •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
Exclusion Criteria
- •Subjects having received steroids or immunosuppressants in recent 3 months will be excluded.
- •Subjects who were hypersensitive to leflunomide will be excluded.
- •ALT and/or AST is more than two folds of the upper limit of relevant reference value at baseline.
- •WBC is less than 3×10\*9/L at baseline.
- •Female patients who are pregnant or breastfeeding.
- •Known significant concurrent medical disease.
Arms & Interventions
Prednisone
Prednisone mono-therapy
Intervention: Prednisone
Prednisone and Leflunomide
Prednisone and Leflunomide combination therapy
Intervention: Prednisone
Prednisone and Leflunomide
Prednisone and Leflunomide combination therapy
Intervention: Leflunomide
Outcomes
Primary Outcomes
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 Outcomes
- Relapse rate at 6 months.(6 months)
- Serum IgG4 concentrations (mg/dL) measured by immunonephelometry at 1, 3, 6 and 12 months.(Up to 12 months)
- Number of circulating plasmablasts (cell number/mL) assessed by flow cytometry by gating peripheral blood at 1, 3, 6 and 12 months.(Up to 12 months)
- Complete response assessed by IgG4-RD Responder Index (IgG4-RD RI) at 1, 3, 6 and 12 months.(Up to 12 months)
- Partial response assessed by IgG4-RD RI at 1, 3, 6 and 12 months.(Up to 12 months)
- Adverse effect events(Up to 12 months)