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

July 4, 2022 updated by: Hoffmann-La Roche
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India, 560034
        • St. John's Medical College Hospital; Rheumatology
      • Bangalore, India, 560079
        • ChanRe Rheumatology And Immunology Center And Research
      • Gujarat, India, 387001
        • MULJIBHAI PATEL UROLOGICAL HOSPITAL; Nephrology
      • Nagpur, India, 440010
        • Jasleen Hospital
      • Noida, India, 201 301
        • Fortis Hospital
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500082
        • Yashoda Hospital
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Medanta-The Medicity
      • Gurgaon, Haryana, India, 122002
        • Fortis Memorial Research Instititute
    • Karnataka
      • Mysuru, Karnataka, India, 570023
        • Apollo BGS Hospitals
    • Maharashtra
      • Mumbai, Maharashtra, India, 400053
        • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; Department of Rheumatologz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Ristova

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events and Serious Adverse Events
Time Frame: Baseline up to 6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
6 months
Number of Severe Flares
Time Frame: At Months 2, 4, 6
At Months 2, 4, 6
Number of Limited Flares
Time Frame: At Months 2, 4, 6
At Months 2, 4, 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2015

Primary Completion (Actual)

June 7, 2022

Study Completion (Actual)

June 7, 2022

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 4, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28550

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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