Evidence map›Paper›PMID 28619061›Full record

Trial reportTrials2017

Rituximab versus cyclophosphamide for the treatment of connective tissue disease-associated interstitial lung disease (RECITAL): study protocol for a randomised controlled trial.

Peter Saunders, Vicky Tsipouri, Gregory J Keir, Deborah Ashby, Marcus D Flather, Helen Parfrey, Daphne Babalis, Elisabetta A Renzoni, Christopher P Denton, Athol U Wells and 1 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 NCT01862926 (A Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung Disease), which is not on this map. Cited by 61 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 4 pooled it
15.7field-weighted citation impact, top 1% 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.

NCT01862926 phase2 / phase3completednot on this map

A Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung Disease

TypeinterventionalSponsorRoyal Brompton & Harefield NHS Foundation TrustRan2014 to 2021Enrolled104ConditionsInterstitial Lung Disease, Scleroderma, Idiopathic Inflammatory Myositis, Mixed Connective Tissue DiseaseArmsRituximab, Cyclophosphamide
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 4 syntheses or guidelines pooled it, 155 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. [What is certain in the treatment of interstitial lung diseases?]Innere Medizin (Heidelberg, Germany) · 2025
    Review
  7. Article
  8. Observational
  9. Article
  10. Machine Learning of Plasma Proteomics Classifies Diagnosis of Interstitial Lung Disease.American journal of respiratory and critical care medicine · 2024
    Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Systemic sclerosis.Lancet (London, England) · 2023
    Review
  16. Article
  17. Current advances in the treatment of systemic sclerosis.Current opinion in pharmacology · 2022
    Review
  18. Review
  19. Review
  20. Antibody Therapies in Autoimmune Inflammatory Myopathies: Promising Treatment Options.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review

1 more citing papers are in PubMed but not listed here.

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

11 authors at 6 institutions in 2 countries.

Peter SaundersNIHR Biomedical Research Unit, Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK.
Vicky TsipouriNIHR Biomedical Research Unit, Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK.
Gregory J KeirPrincess Alexandra Hospital, Brisbane, QLD, Australia.
Deborah AshbyImperial Clinical Trials Unit, School of Public Health, Imperial College London, St. Mary's Campus, Norfolk Place, London, W2 1PG, UK.
Marcus D FlatherNorwich Medical School, University of East Anglia, Norfolk and Norwich University Hospital, Norwich, UK.
Helen ParfreyRespiratory Medicine Division, Department of Medicine, University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, CUHNHSFT and Papworth Hospital NHS Foundation Trust, Cambridge, UK.
Daphne BabalisImperial Clinical Trials Unit, School of Public Health, Imperial College London, St. Mary's Campus, Norfolk Place, London, W2 1PG, UK.
Elisabetta A RenzoniNIHR Biomedical Research Unit, Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK.
Christopher P DentonCentre for Rheumatology and Connective Tissue Diseases, Royal Free Campus, University College London, London, NW3 2PF, UK.
Athol U WellsNIHR Biomedical Research Unit, Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK.
Toby M MaherNIHR Biomedical Research Unit, Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK. t.maher@imperial.ac.uk.
Imperial College London · GBRoyal Brompton Hospital · GBAddenbrooke's Hospital · GBPrincess Alexandra Hospital · AUUniversity College London · GBUniversity of East Anglia · GB

Funding

Department of Health 11/116/03Medical Research CouncilVersus Arthritis 20719
6 · The paper itself

Abstract

backgroundInterstitial lung disease (ILD) frequently complicates systemic autoimmune disorders resulting in considerable morbidity and mortality. The connective tissue diseases (CTDs) most frequently resulting in ILD include: systemic sclerosis, idiopathic inflammatory myositis (including dermatomyositis, polymyositis and anti-synthetase syndrome) and mixed connective tissue disease. Despite the development, over the last two decades, of a range of biological therapies which have resulted in significant improvements in the treatment of the systemic manifestations of CTD, the management of CTD-associated ILD has changed little. At present there are no approved therapies for CTD-ILD. Following trials in scleroderma-ILD, cyclophosphamide is the accepted standard of care for individuals with severe or progressive CTD-related ILD. Observational studies have suggested that the anti-CD20 monoclonal antibody, rituximab, is an effective rescue therapy in the treatment of refractory CTD-ILD. However, before now, there have been no randomised controlled trials assessing the efficacy of rituximab in this treatment population. METHODS/

designRECITAL is a UK, multicentre, prospective, randomised, double-blind, double-dummy, controlled trial funded by the Efficacy and Mechanism Evaluation Programme of the Medical Research Council and National Institute for Health Research. The trial will compare rituximab 1 g given intravenously, twice at an interval of 2 weeks, with intravenously administered cyclophosphamide given monthly at a dose of 600 mg/m DISCUSSION: This is the first randomised control trial to study the efficacy of rituximab as first-line treatment in CTD-associated ILD. The results generated should provide important information on the treatment of a life-threatening complication affecting a rare group of CTDs.

trial registrationClinicalTrials.gov, NCT01862926. Registered on 22 May 2013.

Indexed as

Administration, IntravenousAdrenal Cortex HormonesClinical ProtocolsConnective Tissue DiseasesCyclophosphamideDouble-Blind MethodDrug Administration ScheduleHumansImmunosuppressive AgentsLungLung Diseases, InterstitialOxygen Inhalation TherapyProspective StudiesRecovery of FunctionResearch DesignRituximabAdrenal Cortex HormonesCyclophosphamideImmunosuppressive AgentsRituximabBiomarkersMixed connective tissue diseaseMyositisPulmonary fibrosisRespiratory failureScleroderma

Identifiers

PMID28619061
PMCPMC5471887
OpenAlexW2625915911

What OpenQuestion holds

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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.