A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 23, 2013

Primary Completion Date

May 10, 2018

Study Completion Date

May 10, 2018

Conditions
Granulomatosis With Polyangiitis
Interventions
DRUG

Rituximab

Participants will receive rituximab 375 mg/m\^2 IV infusion on Days 1, 8, 15 and 22. Rituximab infusions will be given at a rate of 25 milligrams per hour (mg/h). This may be escalated at a rate of 25 mg/h increments every 30 minutes to a maximum of 200 mg/h.

Trial Locations (23)

10032

COLUMBIA PRESBYTERIAN MEDICAL CENTER, Research Pharmacy, William Black Medical Research Building, New York

11000

Childrens University Hospital, Belgrade

16147

Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS, Genoa

18000

Clinical Center Nis, Niš

20246

Universitätsklinikum für Kinder und Jugendmedizin Hamburg, Hamburg

34098

Istanbul University, Cerrahpasa Medical Faculty; Pediatrics Department, Istanbul

35128

Univ. Di Padova - Dip. Di Pediatria - Unita' Reumatol. Pediatrica, Padua

40202

University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit, Louisville

44195

The Cleveland Clinic Foundation; Rheumatic and Immunologic Diseases, Cleveland

45229

Cincinnati Childrens Hospital, Cincinnati

69120

KfH-Nierenzentrum fur Kinder und Jugendliche, Heidelberg

69677

Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie, Bron

75743

Hop Necker Enfants Malades;UIH, Paris

84109

University of Utah; Immunology/Rheumatology/Allergy, Salt Lake City

07601

Hackensack University Medical Center, Hackensack

T3B 6A8

Alberta Children'S Hospital, Calgary

V6H 3V4

Children's and Women's Health Center / BC Children's Hospital, Vancouver

M5G 1L7

The Hospital for Sick Children Research Institute, Toronto

00165

Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina, Rome

06100

Hacettepe University, School of Medicine; Pediatrics Department, Ankara

L12 2AP

Alder Hey Children s Hospital; Department of Pediatrics, Liverpool

WC1N 1EH

Great Ormond Street Children's Hospital; Centre of Paediatric & Adolescent Rheumatology, London

NG7 2UH

Nottingham Children's Hospital, Nottingham

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01750697 - A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis | Biotech Hunter | Biotech Hunter