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

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 6, 2015

Primary Completion Date

June 7, 2022

Study Completion Date

June 7, 2022

Conditions
Wegener's Granulomatosis or Microscopic Polyangiitis
Interventions
DRUG

Methylprednisolone

Methyprednisolone will be administered 1 to 3 pulses at a dose of 1000 milligram (mg) IV at the discretion of the investigator.

DRUG

Prednisone

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.

DRUG

Rituximab

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.

Trial Locations (10)

122001

Medanta-The Medicity, Gurgaon

122002

Fortis Memorial Research Instititute, Gurgaon

387001

MULJIBHAI PATEL UROLOGICAL HOSPITAL; Nephrology, Gujarat

400053

Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; Department of Rheumatologz, Mumbai

440010

Jasleen Hospital, Nagpur

500082

Yashoda Hospital, Hyderabad

560034

St. John's Medical College Hospital; Rheumatology, Bangalore

560079

Chanre Rheumatology and Immunology Center and Research, Bangalore

570023

Apollo BGS Hospitals, Mysuru

201 301

Fortis Hospital, Noida

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02115997 - A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis | Biotech Hunter | Biotech Hunter