Leflunomide for Maintenance of Remission in IgG4 Related Disease (NCT02703194) | Clinical Trial Compass
CompletedPhase 4
Leflunomide for Maintenance of Remission in IgG4 Related Disease
China68 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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.
✓. 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).
✓. Clinical examination showing characteristic diffuse/localized swelling or masses in single or multiple organs.
✓. 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).
✓. 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.