Evidence map›Paper›PMID 29016646›Full record

Trial reportPloS one2017

Methotrexate versus cyclophosphamide for remission maintenance in ANCA-associated vasculitis: A randomised trial.

Federica Maritati, Federico Alberici, Elena Oliva, Maria L Urban, Alessandra Palmisano, Francesca Santarsia, Simeone Andrulli, Laura Pavone, Alberto Pesci, Chiara Grasselli and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00751517 (Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.), which is not on this map. Cited by 23 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 7 pooled it
3.5field-weighted citation impact, top 7% 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.

NCT00751517 phase2unknown statusnot on this map

Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.

TypeinterventionalSponsorUniversity of ParmaConditionsWegener's Granulomatosis, Churg-Strauss Syndrome, Microscopic Polyangiitis, Polyarteritis NodosaArmsMethotrexate, Cyclophosphamide
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 7 syntheses or guidelines pooled it, 80 citations in OpenAlex.

  1. [Diagnosis and treatment of ANCA-associated vasculitis : SHORT VERSION of the S3 guideline of the German Society for Rheumatology and Clinical Immunology e. V. (DGRh) and German Society for Internal Medicine e. V. (DGIM), German Society for Nephrology e. V. (DGfN), German Society for Otorhinolaryngology and Head and Neck Surgery e. V. (DGHNO-KHC), German Ophthalmological Society e. V. (DOG), German Society for Neurology e. V. (DGN), German Society for Pneumology and Respiratory Medicine e. V. (DGP), German Society for Pathology e. V. (DGP), German Radiological Society, Society for Medical Radiology e. V. (DRG), Federal Association of German Pathologists, Federal Kidney Association e. V., German Rheumatism League Federal Association e. V.]Zeitschrift fur Rheumatologie · 2025
    Guideline
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Guideline
  6. Guideline
  7. Interventions for renal vasculitis in adults.The Cochrane database of systematic reviews · 2020
    Pooled it
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. Eosinophilic Vasculitis.Current rheumatology reports · 2020
    Review
  20. Effectiveness and safety of methotrexateTherapeutic advances in chronic disease · 2020
    Article
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

15 authors at 5 institutions in 1 country.

Federica MaritatiNephrology Unit, University Hospital of Parma, Italy.
Federico AlbericiNephrology and Immunology Unit, ASST Santi Paolo e Carlo, San Carlo Borromeo Hospital, Milano, Italy.
Elena OlivaNephrology Unit, University Hospital of Parma, Italy.
Maria L UrbanNephrology Unit, University Hospital of Parma, Italy.
Alessandra PalmisanoNephrology Unit, University Hospital of Parma, Italy.
Francesca SantarsiaNephrology Unit, University Hospital of Parma, Italy.
Simeone AndrulliNephrology and Dialysis Unit, A. Manzoni Hospital, Lecco, Italy.
Laura PavoneNephrology Unit, IRCCS Fondazione Cà Granda Maggiore Policlinico Hospital, Milano, Italy.
Alberto PesciPneumology, Bicocca University, Milano, Italy.
Chiara GrasselliInternal Medicine, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy.
Rosaria SantiInternal Medicine, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy.
Bruno TumiatiInternal Medicine, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy.
Lucio ManentiNephrology Unit, University Hospital of Parma, Italy.
Carlo BuzioNephrology Unit, University Hospital of Parma, Italy.
Augusto VaglioNephrology Unit, University Hospital of Parma, Italy.ORCID http://orcid.org/0000-0002-3814-9172
University of Parma · ITAlessandro Manzoni Hospital · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITOspedale San Carlo · ITUniversity of Milano-Bicocca · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is based on remission-induction and remission-maintenance. Methotrexate is a widely used immunosuppressant but only a few studies explored its role for maintenance in AAV. This trial investigated the efficacy and safety of methotrexate as maintenance therapy for AAV.

methodsIn this single-centre, open-label, randomised trial we compared methotrexate and cyclophosphamide for maintenance in AAV. We enrolled patients with granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA), the latter with poor-prognosis factors and/or peripheral neuropathy. Remission was induced with cyclophosphamide. At remission, the patients were randomised to receive methotrexate or to continue with cyclophosphamide for 12 months; after treatment, they were followed for another 12 months. The primary end-point was relapse; secondary end-points included renal outcomes and treatment-related toxicity.

resultsOf the 94 enrolled patients, 23 were excluded during remission-induction or did not achieve remission; the remaining 71 were randomised to cyclophosphamide (n = 33) or methotrexate (n = 38). Relapse frequencies at months 12 and 24 after randomisation were not different between the two groups (p = 1.00 and 1.00). Relapse-free survival was also comparable (log-rank test p = 0.99). No differences in relapses were detected between the two treatments when GPA+MPA and EGPA were analysed separately. There were no differences in eGFR at months 12 and 24; proteinuria declined significantly (from diagnosis to month 24) only in the cyclophosphamide group (p = 0.0007). No significant differences in adverse event frequencies were observed.

conclusionsMTX may be effective and safe for remission-maintenance in AAV.

trial registrationclinicaltrials.gov NCT00751517.

Indexed as

AdolescentAdultAgedAntibodies, Antineutrophil CytoplasmicAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisChurg-Strauss SyndromeCyclophosphamideFemaleGranulomatosis with PolyangiitisHumansImmunosuppressive AgentsMaleMethotrexateMicroscopic PolyangiitisMiddle AgedPatient SafetyAntibodies, Antineutrophil CytoplasmicCyclophosphamideImmunosuppressive AgentsMethotrexate

Identifiers

PMID29016646
PMCPMC5634660
OpenAlexW2762815886

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.