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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

Rituximab versus azathioprine as therapy for maintenance of remission for anti-neutrophil cytoplasm antibody-associated vasculitis (RITAZAREM): study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Seerapani Gopaluni, Rona M. Smith, Michelle Lewin, Carol A. McAlear, Kim Mynard, Rachel B. Jones, Ulrich Specks, Peter A. Merkel, David R. W. Jayne, on behalf of the RITAZAREM Investigators
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1857-z) contains supplementary material, which is available to authorized users.

Abstract

Background

Rituximab is effective as therapy for induction of remission in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). However, the effect of rituximab is not sustained, and subsequent relapse rates are high, especially in patients with a history of relapse. There is a need to identify whether maintenance therapy with rituximab is superior to the current standard of azathioprine or methotrexate for prevention of relapse following induction with rituximab.

Methods/design

RITAZAREM is an international, multicenter, open-label, randomized controlled trial designed to demonstrate the superiority of repeated doses of intravenous rituximab compared to daily orally administered azathioprine as a relapse prevention strategy in patients with AAV with relapsing disease who undergo induction of remission with rituximab. Patients with AAV will be recruited at the time of relapse and will receive rituximab and glucocorticoid induction therapy. If the disease is controlled by 4 months, patients will be randomized in a 1:1 ratio to receive rituximab (1000 mg every 4 months for five doses) or azathioprine (2 mg/kg/day) as maintenance therapy. Patients will be followed for a minimum of 36 months. The primary outcome is the time to disease relapse. It is estimated that 190 patients will need to be recruited to ensure that at least 160 are randomized.

Discussion

The RITAZAREM trial will provide the largest trial dataset for the use of rituximab as remission-induction therapy for patients with AAV comparing two remission-maintenance strategies following induction with rituximab, and explore whether prolonged B-cell depletion leads to sustained treatment-free remissions after discontinuation of immunosuppressive therapy.

Trial registration

ClinicalTrials.gov identifier: NCT01697267. Registered on 31 August 2012.
Zusatzmaterial
Additional file 1: SPIRIT_Fillable-checklist-RITAZAREM; populated SPIRIT Checklist. (DOC 122 kb)
13063_2017_1857_MOESM1_ESM.doc
Additional file 2: Inclusion and exclusion criteria for RITAZAREM trial; full list of enrollment requirements. (DOC 34 kb)
13063_2017_1857_MOESM2_ESM.doc
Additional file 3: RITAZAREM trial flow chart; RITAZAREM study schema. (DOC 68 kb)
13063_2017_1857_MOESM3_ESM.doc
Additional file 4: SPIRIT figure: RITAZAREM schedule of events; populated SPIRIT figure. (DOC 75 kb)
13063_2017_1857_MOESM4_ESM.doc
Literatur
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