Back to resultsA Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis
Primary Purpose
Wegener's Granulomatosis or Microscopic Polyangiitis
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Methylprednisolone
Prednisone
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Wegener's Granulomatosis or Microscopic Polyangiitis
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
Sites / Locations
- Yashoda Hospital
- Medanta-The Medicity
- Fortis Memorial Research Instititute
- Apollo BGS Hospitals
- Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; Department of Rheumatologz
- St. John's Medical College Hospital; Rheumatology
- Chanre Rheumatology and Immunology Center and Research
- MULJIBHAI PATEL UROLOGICAL HOSPITAL; Nephrology
- Jasleen Hospital
- Fortis Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rituximab
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Participants With Adverse Events and Serious Adverse Events
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
Secondary Outcome Measures
Percentage of Participants Who Achieved a BVAS/WG Score of 0 During Treatment With Prednisone at a Dose of Less Than (<) 10 mg/day
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
Percentage of Participants Who Achieved and Maintained Partial Remission (Defined as Having a BVAS/WG of 1 or 2)
Number of Severe Flares
Number of Limited Flares
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02115997
Brief Title
A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 6, 2015 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wegener's Granulomatosis or Microscopic Polyangiitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
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
Intervention Name(s)
Prednisone
Intervention Description
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
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Ristova
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events and Serious Adverse Events
Time Frame
Baseline up to 6 months
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Percentage of Participants Who Achieved and Maintained Partial Remission (Defined as Having a BVAS/WG of 1 or 2)
Time Frame
6 months
Title
Number of Severe Flares
Time Frame
At Months 2, 4, 6
Title
Number of Limited Flares
Time Frame
At Months 2, 4, 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Yashoda Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Medanta-The Medicity
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Fortis Memorial Research Instititute
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122002
Country
India
Facility Name
Apollo BGS Hospitals
City
Mysuru
State/Province
Karnataka
ZIP/Postal Code
570023
Country
India
Facility Name
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; Department of Rheumatologz
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400053
Country
India
Facility Name
St. John's Medical College Hospital; Rheumatology
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
Chanre Rheumatology and Immunology Center and Research
City
Bangalore
ZIP/Postal Code
560079
Country
India
Facility Name
MULJIBHAI PATEL UROLOGICAL HOSPITAL; Nephrology
City
Gujarat
ZIP/Postal Code
387001
Country
India
Facility Name
Jasleen Hospital
City
Nagpur
ZIP/Postal Code
440010
Country
India
Facility Name
Fortis Hospital
City
Noida
ZIP/Postal Code
201 301
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis
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