A phase IIa, International, Multicenter, Open-label, Uncontrolled Study to Evaluate the Safety and Pharmacokinetics of 4x 375mh/m2 Intravenous Rituximab in Pediatric Patients with Severe Granulomatosis with Polyangiitis (Wegener's) or Microscopic Polyangiitis
Sponsor: |
Hoffmann-La Roche |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAO3002 |
U.S. Govt. ID: |
NCT01750697 |
Contact: |
Lisa Imundo: 212-305-4308 / lfi1@columbia.edu |
The purpose of this study is to evaluate the safety and tolerability of a study drug called rituximab in pediatric patients with sever granulomatosis with polyangiitis (GPA) microscopic polyangiitis (MPA). Rituximab is used to treat people with cancer or arthritis. It has also been shown toimprove GPA (previously known as Wegeners granulomatosis) and MPA (microscopic polyangiitis)in adults, and we want to find out whether this medicine is also okay to use in children andadolescents with GPA or MPA.
This study is closed
Investigator
Lisa Imundo, MD
Does your child have a diagnosis of granulomatosis with polyangiitis or diagnosis of microscopic polyangiitis? |
Yes |
No |
Does your child have history of serious or chronic infection? |
Yes |
No |
Does your child have a history of cancer? |
Yes |
No |