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

 -  Male or non-pregnant, non-nursing female

 -  Diagnosed with Wegener's granulomatosis or Microscopic polyangiitis according to the
 definitions of the Chapel Hill Consensus Conference

 -  Participants with either newly diagnosed or relapsing disease

 -  Participants must have active disease as per the BVAS/WG greater than equal to (>/=) 3
 that would normally require treatment with cyclophosphamide (CYC)

 -  Participants willing to practice medically acceptable contraception during and 1 year
 after the completion of rituximab therapy

 -  Participants must have severe disease i.e. one or more of the major BVAS/WG items
 depicting severity or disease severe enough to require treatment with CYC.

 -  Participants must be positive for either proteinase 3-antineutrophil cytoplasmic
 antibodies (PR3-ANCA) or myeloperoxidase-antineutrophil cytoplasmic antibodies
 (MPO-ANCA) at the screening

 Exclusion Criteria:

 -  History of severe allergic or anaphylactic reactions to human, humanized, or murine
 monoclonal antibodies

 -  Participants in a severely immunocompromised state

 -  Participants with severe heart failure (New York Heart Association Class IV) or
 severe, uncontrolled cardiac disease

 -  Participants having active severe infection or history of recurrent bacterial, viral,
 fungal, mycobacterial or other infections

 -  Participants who had a live vaccine fewer than 4 weeks before first dose of rituximab

 -  Any other condition which puts the participant to undue risk for rituximab therapy as
 per local prescribing information or Investigator's judgment

 -  Participants with any previous treatment with rituximab

 -  Participants with any previous treatment with alemtuzumab

 -  Participants who have had treatment with infliximab within the previous 3 months

 -  Participants who have had treatment with adalimumab within the previous 2 months

 -  Participants who have had treatment with etanercept within the previous month

 -  Participants with any other investigational medication within the previous month