Rituximab in GPA / MPA paediatric patients

• Research type

  Research Study

• Full title

  WA25615 - A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 intravenous rituximab in paediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis.

• IRAS ID

  112721

• Contact name

  Paul Brogan

• Sponsor organisation

  Hoffmann La-Roche Ltd

• Eudract number

  2012-002062-13

• Research summary

  This study is being carried out to find out whether rituximab is safe and tolerable in children with severe granulomatosis with polyangiitis (Wegeners) or microscopic polyangiitis. Children should be aged 2 to <18 years. This is a one arm study consisting of 4 phases: *Screening where all children will be screened for eligibility. *Remission induction phase where all children will be given at least 3 and no more than 6 courses of IV methylprednisolone at least one day apart and prior to study drug dosing on day 1. All children will then receive 4 doses of rituximab one week apart starting on day 1. All children will also be given daily oral prednisone which will be tapered to a minimum of 0.2mg/kg/day by month 6. *Follow-up phase where all children will attend every 3 months for a minimum of 12 months. After month 18 all patients will continue to be seen 3 monthly until the common close out date. *Extended follow up where all children whose b-cells and/or immunoglobulins remain depleted will continue to be seen every 3 months until their counts have returned to the normal limits or baseline levels. Recruitment is expected to last until end of 2014.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  13/LO/0010

• Date of REC Opinion

  18 Jan 2013

• REC opinion

  Favourable Opinion