Evidence map›Paper›PMID 34210720›Full record

ArticleBMJ open2021

Prospective randomised controlled trial of adults with perianal fistulising Crohn's disease and optimised therapeutic infliximab levels: PROACTIVE trial study protocol.

Bonita Gu, Michael De Gregorio, Joseph Louis Pipicella, Niels Vande Casteele, Jane M Andrews, Jakob Begun, William Connell, Basil D'Souza, Ali Gholamrezaei, Ailsa Hart and 12 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Perianal Crohn's disease: Still more questions than answers.World journal of gastroenterology · 2024
    Article
  2. Article
  3. Review
  4. Review
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

22 authors at 11 institutions in 4 countries.

Bonita GuSouth Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.ORCID 0000-0002-9264-1854
Michael De GregorioDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
Joseph Louis PipicellaDepartment of Gastroenterology and Hepatology, Liverpool Hospital, Sydney, New South Wales, Australia.ORCID 0000-0002-1796-918X
Niels Vande CasteeleDepartment of Medicine, University of California San Diego, La Jolla, California, USA.
Jane M AndrewsDepartment of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Jakob BegunImmunity, Infection, and Inflammation Program, Mater Research Institute, Brisbane, Queensland, Australia.
William ConnellDepartment of Gastroenterology and Hepatology, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.
Basil D'SouzaDepartment of Colorectal Surgery, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.
Ali GholamrezaeiDepartment of Gastroenterology and Hepatology, Liverpool Hospital, Sydney, New South Wales, Australia.
Ailsa HartInflammatory Bowel Diseases Unit, St Mark's Hospital, Harrow, UK.
Danny LiewSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Graham Radford-SmithDepartment of Gastroenterology and Hepatology, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
Jordi RimolaInflammatory Bowel Disease Unit, Department of Radiology, Hospital Clinic de Barcelona, Barcelona, Spain.
Tom SutherlandDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
Catherine ToongSouth Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Rodney WoodsDepartment of Colorectal Surgery, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.
Yang WuSouth Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Wei XuanSouth Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Astrid-Jane WilliamsSouth Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Watson NgSouth Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Nik Sheng DingDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
Susan ConnorSouth Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia Susan.Connor1@health.nsw.gov.au.
Liverpool Hospital · AUSt Vincent's Hospital Melbourne · AUThe University of Melbourne · AUUNSW Sydney · AUHospital Clínic de Barcelona · ESMater Research · AUMonash University · AURoyal Adelaide Hospital · AURoyal Brisbane and Women's Hospital · AUSt Mark's Hospital · GBUniversity of California San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPerianal fistulising Crohn's disease (pfCD) can be somewhat treatment refractory. Higher infliximab trough levels (TLIs) may improve fistula healing rates; however, it remains unclear whether escalating infliximab therapy to meet higher TLI targets using proactive, or routine, therapeutic drug monitoring (TDM) improves outcomes. This randomised controlled trial aimed to assess whether infliximab therapy targeting higher TLIs guided by proactive TDM improves outcomes compared with standard therapy. METHODS AND ANALYSIS: Patients with active pfCD will be randomised 1:1 to either the proactive TDM arm or standard dosing arm and followed up for 54 weeks. Patients in the proactive TDM arm will have infliximab dosing optimised to target higher TLIs. The targets will be TLI ≥ 25 µg/mL at week 2, ≥ 20 µg/mL at week 6 and ≥ 10 µg/mL during maintenance therapy. The primary objective will be fistula healing at week 32. Secondary objectives will include fistula healing, fistula closure, radiological fistula healing, patient-reported outcomes and economic costs up to 54 weeks. Patients in the standard dosing arm will receive conventional infliximab dosing not guided by TLIs (5 mg/kg at weeks 0, 2 and 6, and 5 mg/kg 8 weekly thereafter). Patients aged 18-80 years with pfCD with single or multiple externally draining complex perianal fistulas who are relatively naïve to infliximab treatment will be included. Patients with diverting ileostomies or colostomies and pregnant or breast feeding will be excluded. Fifty-eight patients per arm will be required to detect a 25% difference in the primary outcome measure, with 138 patients needed to account for an estimated 6.1% primary non-response rate and 10% dropout rate. ETHICS AND DISSEMINATION: Results will be presented in peer-reviewed journals and international conferences. Ethics approval has been granted by the South Western Sydney Local Health District Human Research Ethics Committee in Australia. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12621000023853); Pre-results.

Indexed as

Crohn DiseaseRectal FistulaAdultAustraliaGastrointestinal AgentsHumansInfliximabProspective StudiesRandomized Controlled Trials as TopicTreatment OutcomeGastrointestinal AgentsInfliximabclinical trialsinflammatory bowel diseaseprotocols & guidelines

Identifiers

PMID34210720
PMCPMC8252869
OpenAlexW3175457825

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.