NCT01697267 - Rituximab Vasculitis Maintenance Study | Biotech Hunter

Enrollment

188

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

November 22, 2018

Study Completion Date

November 21, 2019

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisMicroscopic PolyangiitisWegener Granulomatosis

Interventions

BIOLOGICAL

Rituximab

Rituximab IV infusion 1000 mg x 1 dose at months 4, 8, 12, 16 and 20 and glucocorticoids. Four - six hour infusion. Treatment with rituximab will cease at month 20.

DRUG

Azathioprine

"Oral dosage form. Target dose is 2mg/kg; maximum daily dose is 200mg. This should be continued until month 24. The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27.~The dose should be rounded down to the nearest 25mg. The dose may vary on alternate days e.g. 100mg one day, 150mg the next for patients on an overall dose of 125mg daily.~If patients are aged over 60 years, reduce the dose by 25%. If patients are aged over 75 years, reduce the dose by 50%."

Trial Locations (38)

1023

Auckland City Hospital, Grafton

4029

Royal Brisbane & Women's Hospital, Herston

10021

Hospital for Special Surgery, New York

15260

University of Pittsburgh, Pittsburgh

19104

University of Pennsylvania, Philadelphia

27599

University of North Carolina, Chapel Hill

43100

University Hospital of Parma, Parma

44195

Cleveland Clinic, Cleveland

48109

University of Michigan, Ann Arbor

55905

Mayo Clinic, Rochester

84112

University of Utah, Salt Lake City

90048

Cedars-Sinai Medical Center, Los Angeles

Unknown

Canberra Hospital, Garran

Royal Adelaide Hospital, Adelaide

General Faculty Hospital, Prague

Cork University Hospital, Cork

North Shore Hospital, Westlake

Karolinska University Hospital, Stockholm

L8N 4A6

St. Joseph's Healthcare, Hamilton

M5T 3L9

Mount Sinai Hospital, Toronto

700-0082

Okayama University, Kita-ku

263-8522

Chiba University, Chiba

606-8501

Kitano Hospital, Kyoto

889-2192

University of Miyazaki, Miyazaki

173-0003

Teikyo University, Tokyo

173-0015

Tokyo Metropolitan Geriatric, Tokyo

192-0005

Kyorin University school of medicine, Tokyo

LE5 4PW

Leicester General Hospital, Leicester

B15 2WB

Queen Elizabeth Hospital, Birmingham

BN2 5BE

Brighton and Sussex University Hospitals, Brighton

CB2 0QQ

Addenbrooke's Hospital, Cambridge

DY1 2HQ

Russells Hall Hospital, Dudley

IP4 5PD

Ipswich Hospital, Ipswich

LS7 4SA

Chapel Allerton Hospital, Leeds

W12 0NN

Imperial College, London

TS4 3BW

James Cook University Hospital, Middlesbrough

NG7 2UH

Queen's Medical Centre Campus, Nottingham University Hosp, Nottingham

OX1 2JD

University of Oxford, Oxford