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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Methyprednisolone will be administered 1 to 3 pulses at a dose of 1000 milligram (mg) IV at the discretion of the investigator.
Prednisone will be administered orally at tapered dose (start at 1 milligrams per kilogram per day \[mg/kg/day\]) at the discretion of investigator given daily until participants are off the drug.
Rituximab will be administered at 375 milligrams per meter square (mg/m\^2) of body surface area given by IV infusion once weekly from Week 1 to 4.
Yashoda Hospital
Hyderabad, Andhra Pradesh, India
MULJIBHAI PATEL UROLOGICAL HOSPITAL; Nephrology
Gujarat, Gujarat, India
Medanta-The Medicity
Gurgaon, Haryana, India
Fortis Memorial Research Instititute
Gurgaon, Haryana, India
Apollo BGS Hospitals
Mysuru, Karnataka, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; Department of Rheumatologz
Mumbai, Maharashtra, India
St. John's Medical College Hospital; Rheumatology
Bangalore, India
Chanre Rheumatology and Immunology Center and Research
Bangalore, India
Jasleen Hospital
Nagpur, India
Fortis Hospital
Noida, India
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
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
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