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

NCT ID: NCT02115997

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-06
• Study Completion Date: 2022-06-07

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.

Conditions

Wegener's Granulomatosis or Microscopic Polyangiitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab

Participants will receive IV infusion of rituximab once weekly from Week 1 to 4. Participants will also receive one pulse of methylprednisolone, followed by a tapering dose of oral prednisolone at the discretion of the investigator. Methylprednisolone may be repeated up to total of 3 pulses at the discretion of the investigator.

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: DRUG

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

Prednisone

Intervention Type: DRUG

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

Intervention Type: 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.

Interventions

Methylprednisolone

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ristova

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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

Countries

India

Other Identifiers

ML28550

Identifier Type: -

Identifier Source: org_study_id