Clinical Trial: A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis

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

Official Title:

Brief Summary: This is a perspective, Phase IV, multi-center, single arm, open-label, interventional study in adult participants with Wegener's granulomatosis (granulomatosis with polyangiitis [GPA]) or microscopic polyangiitis. Participants will be treated with rituximab (Ristova) and glucocorticoids. Rituximab will be administered by intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) body surface area once weekly during Weeks 1 to 4. Participants will also receive one or three pulses of methylprednisolone (1000 milligram [mg] each), followed by a tapering dose of oral prednisolone (start dose of 1 mg per kilogram per day). The dose of oral prednisone will be reduced as per evaluation by the investigator till the participant is completely off the drug. The participants will be followed up for duration of 6 months from the date of starting rituximab therapy with three follow-up visits at Days 52, 112 and 172. All adverse events occurring during this period will be captured.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome:

  • Percentage of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Baseline up to 6 months ]
  • Percentage of Participants Who Achieved a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) Score of 0 and Successfully Completed Prednisone Taper at 6 Months [ Time Frame: 6 months ]


Original Primary Outcome: Percentage of patients with Wegener's Granulomatosis (GPA) and microscopic polyangiitis achieving a Birmingham Vasculitis Activity Score for GPA (BVAS/WG) score of 0 and successful completion of the prednisone taper at 6 months [ Time Frame: 6 months ]

Current Secondary Outcome:

  • Percentage of Participants Who Achieved a BVAS/WG Score of 0 During Treatment With Prednisone at a Dose of Less Than (<) 10 mg/day [ Time Frame: 6 months ]
  • Percentage of Participants With Refractory Antineutrophil Cytoplasmic Antibodies-Associated Vasculitis (AAV) Who Achieved BVAS/WG Score of 0 and Successfully Completed Prednisone Taper at 6 Months [ Time Frame: 6 months ]
  • Percentage of Participants Who Achieved and Maintained Partial Remission (Defined as Having a BVAS/WG of 1 or 2) [ Time Frame: 6 months ]
  • Number of Severe Flares [ Time Frame: At Months 2, 4, 6 ]
  • Number of Limited Flares [ Time Frame: At Months 2, 4, 6 ]


Original Secondary Outcome:

  • Percentage of patients achieving BVAS/WG score of 0 during treatment with prednisone at a dose of less than 10 mg per day [ Time Frame: 6 months ]
  • Percentage of patients with refractory antineutrophil cytoplasmic antibodies-associated vasculitis (AAV) achieving BVAS/WG score of 0 and successful completion of the prednisone taper [ Time Frame: 6 months ]
  • Percentage of patients who achieve and maintain partial remission (defined as having a BVAS/WG of 1 or 2) [ Time Frame: 6 months ]
  • Number of Severe Flares [ Time Frame: 6 months ]
  • Number of Limited Flares [ Time Frame: 6 months ]
  • Incidence of adverse events [ Time Frame: 6 months ]


Information By: Hoffmann-La Roche

Dates:
Date Received: April 14, 2014
Date Started: July 2015
Date Completion: April 2018
Last Updated: November 1, 2016
Last Verified: November 2016