Clinical Trial: Leflunomide for Maintenance of Remission in IgG4 Related Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease

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 Summary: 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.
Sponsor: Chinese PLA General Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Complete response assessed by IgG4-RD Responder Index (IgG4-RD RI) at 1, 3 and 6 months. [ Time Frame: Up to 6 months ]

Complete response (CR) is defined as IgG4-RD RI <3 at 1, 3 and 6 months.


Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • Serum IgG4 concentrations (mg/dL) measured by immunonephelometry at 1, 3, 6 and 12 months. [ Time Frame: 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. [ Time Frame: Up to 12 months ]
  • Adverse effect events [ Time Frame: Up to 12 months ]
    Treatment-related adverse effect, including abnormal liver function and leukopenia.


Original Secondary Outcome:

  • Partial response assessed by IgG4-RD RI at 1, 3 and 6 months. [ Time Frame: Up to 6 months ]
    Partial response (PR) is defined as IgG4-RD RI remaining ≥3 at 1, 3 and 6 months.
  • Disease response assessed by IgG4-RD RI at 1, 3 and 6 months. [ Time Frame: Up to 6 months ]
    Disease response (DR) is defined as a decline in the IgG4-RD RI by >2 points over baseline.
  • Serum IgG4 concentrations (mg/dL) measured by immunonephelometry at 1, 3 and 6 months. [ Time Frame: Up to 6 months ]
  • Number of circulating plasmablasts (cell number/mL) assessed by flow cytometry by gating peripheral blood at 1, 3 and 6 months. [ Time Frame: Up to 6 months ]
  • Adverse effect events [ Time Frame: Up to 6 months ]
    Treatment-related adverse effect, including abnormal liver function and leukopenia.


Information By: Chinese PLA General Hospital

Dates:
Date Received: February 27, 2016
Date Started: March 2016
Date Completion: March 2019
Last Updated: March 30, 2016
Last Verified: March 2016