Clinical Trial: A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granul
Brief Summary: This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Participants will receive rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8, 15 and 22.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome:
- Percentage of Participants With Adverse Events (AEs), Including Serious AEs [ Time Frame: Baseline up to last visit (1.5-5 years) ]
- Pharmacokinetics: Rituximab Clearance (CL) [ Time Frame: Pre-dose (0 hour) on Days 1, 8, 15, 22; 30 minutes post infusion on Days 1 and 22 and then on Day 29, Months 2, 4, 6, 9, 18, thereafter every 6 months up to approximately 1.5-5 years overall ]
- Pharmacokinetics: Volume of Distribution of Rituximab [ Time Frame: Pre-dose (0 hour) on Days 1, 8, 15, 22; 30 minutes post infusion on Days 1 and 22 and then on Day 29, Months 2, 4, 6, 9, 18, thereafter every 6 months up to approximately 1.5-5 years overall ]
Original Primary Outcome:
- Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ]
- Safety: Nature and severity of adverse events [ Time Frame: approximately 3.5 years ]
- Pharmacokinetics: Clearance (CL) [ Time Frame: up to Day 22 and at Month 1, 2, 4 and 6 ]
- Pharmacokinetics: Volume of distribution [ Time Frame: up to Day 22 and at Month 1, 2, 4 and 6 ]
Current Secondary Outcome:
- Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Rituximab [ Time Frame: Pre-dose (0 hour) on Days 1, 8, 15, 22; 30 minutes post infusion on Days 1 and 22 and then on Day 29, Months 2, 4, 6, 9, 18, thereafter every 6 months up to approximately 1.5-5 years overall ]
- Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Rituximab [ Time Frame: Pre-dose (0 hour) on Days 1, 8, 15, 22; 30 minutes post infusion on Days 1 and 22 and then on Day 29, Months 2, 4, 6, 9, 18, thereafter every 6 months up to approximately 1.5-5 years overall ]
Original Secondary Outcome:
- Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: up to Day 22 and at Month 1, 2, 4 and 6 ]
- Pharmacokinetics: Maximum concentration (Cmax) [ Time Frame: up to Day 22 and at Month 1, 2, 4 and 6 ]
Information By: Hoffmann-La Roche
Dates:
Date Received: December 13, 2012
Date Started: May 23, 2013
Date Completion: May 16, 2018
Last Updated: April 4, 2017
Last Verified: April 2017