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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|ClinicalTrials.gov Identifier: NCT02115997|
Recruitment Status : Recruiting
First Posted : April 16, 2014
Last Update Posted : December 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Wegener's Granulomatosis or Microscopic Polyangiitis||Drug: Methylprednisolone Drug: Prednisone Drug: Rituximab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||July 6, 2015|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
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.
Methyprednisolone will be administered 1 to 3 pulses at a dose of 1000 milligram (mg) IV at the discretion of the investigator.
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 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 Name: Ristova
- Percentage of Participants With Adverse Events and Serious Adverse Events [ Time Frame: 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 ]
- 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 ]
- 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 ]
- Percentage of Participants Who Achieved and Maintained Partial Remission (Defined as Having a BVAS/WG of 1 or 2) [ Time Frame: 6 months ]
- Number of Severe Flares [ Time Frame: At Months 2, 4, 6 ]
- Number of Limited Flares [ Time Frame: At Months 2, 4, 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115997
|Contact: Reference Study ID Number: ML28550 https://forpatients.roche.com/||888-662-6728 (U.S. and Canada)||email@example.com|
|Study Director:||Clinical Trials||Hoffmann-La Roche|