Evidence map›Paper›PMID 28270229›Full record

Trial reportTrials2017

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

Seerapani Gopaluni, Rona M Smith, Michelle Lewin, Carol A McAlear, Kim Mynard, Rachel B Jones, Ulrich Specks, Peter A Merkel, David R W Jayne, RITAZAREM Investigators

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01697267 (An International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated Vasculitis), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
8.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01697267 phase3completednot on this map

An International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated Vasculitis

TypeinterventionalSponsorCambridge University Hospitals NHS Foundation TrustRan2013 to 2019Enrolled188ConditionsAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Microscopic Polyangiitis, Wegener GranulomatosisArmsRituximab, Azathioprine
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 74 citations in OpenAlex.

  1. Interventions for renal vasculitis in adults.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Off-Label Uses of Rituximab in Dermatology.Current dermatology reports · 2022
    Review
  14. Review
  15. PR3-ANCAs predict relapses in ANCA-associated vasculitis patients after rituximab.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021
    Article
  16. Novel Therapies for ANCA-associated Vasculitis.Current rheumatology reports · 2021
    Review
  17. Article
  18. Article
  19. Review
  20. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 2 countries.

Seerapani GopaluniUniversity of Cambridge Hospitals NHS Foundation Trust, Cambridge, UK.
Rona M SmithUniversity of Cambridge Hospitals NHS Foundation Trust, Cambridge, UK. Ronasmith@doctors.net.uk.
Michelle LewinUniversity of Cambridge Hospitals NHS Foundation Trust, Cambridge, UK.
Carol A McAlearDivision of Rheumatology and Department of Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.
Kim MynardUniversity of Cambridge Hospitals NHS Foundation Trust, Cambridge, UK.
Rachel B JonesUniversity of Cambridge Hospitals NHS Foundation Trust, Cambridge, UK.
Ulrich SpecksDepartment of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN, USA.
Peter A MerkelDivision of Rheumatology and Department of Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.
David R W JayneUniversity of Cambridge Hospitals NHS Foundation Trust, Cambridge, UK.
RITAZAREM Investigators
University of Cambridge · GBMayo Clinic in Florida · US

Funding

VCRC-VF FellowshipU54AR057319 · NIAMS · UNIVERSITY OF PENNSYLVANIA · PI MERKEL, PETER A · 2009 to 2020
$12.5M
Arthritis Research UKNIAMS NIH HHS U54 AR057319Versus Arthritis 19706
6 · The paper itself

Abstract

backgroundRituximab 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/

designRITAZAREM 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 registrationClinicalTrials.gov identifier: NCT01697267 . Registered on 31 August 2012.

Indexed as

Administration, IntravenousAdministration, OralAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisAustraliaAzathioprineClinical ProtocolsEuropeGlucocorticoidsHumansImmunosuppressive AgentsJapanMaintenance ChemotherapyNew ZealandRecurrenceRemission InductionResearch DesignAzathioprineGlucocorticoidsImmunosuppressive AgentsRituximabANCA-associated vasculitisAzathioprineRandomized clinical trialRITAZAREMRituximab

Identifiers

PMID28270229
PMCPMC5341185
OpenAlexW2591828703

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.