Evidence map›Paper›PMID 32041649›Full record

ArticleTrials2020

A randomised placebo controlled trial of anakinra for treating pustular psoriasis: statistical analysis plan for stage two of the APRICOT trial.

Suzie Cro, Prakash Patel, Jonathan Barker, David A Burden, Christopher E M Griffiths, Helen J Lachmann, Nick J Reynolds, Richard B Warren, Francesca Capon, Catherine Smith and 1 more

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

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 39% 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

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
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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 8 institutions in 1 country.

Suzie CroImperial Clinical Trials Unit, Imperial College London, W12 7RH, London, UK. s.cro@imperial.ac.uk.ORCID http://orcid.org/0000-0002-6113-1173
Prakash PatelSt. John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Jonathan BarkerSt. John's Institute of Dermatology, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.
David A BurdenInstitute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, G12 8TA, UK.
Christopher E M GriffithsCentre for Dermatology Research, University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, UK.
Helen J LachmannNational Amyloidosis Centre, University College London, NW3 2PF, London, UK.
Nick J ReynoldsTranslational and Clinical Research Institute, University of Newcastle, Newcastle upon Tyne, NE1 7RU, UK.
Richard B WarrenDermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.
Francesca CaponDepartment of Medical & Molecular Genetics, King's College London, London, SE1 9RT, UK.
Catherine SmithSt. John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Victoria CorneliusImperial Clinical Trials Unit, Imperial College London, W12 7RH, London, UK.
King's College London · GBImperial College London · GBGuy's and St Thomas' NHS Foundation Trust · GBNewcastle University · GBSalford Royal NHS Foundation Trust · GBUniversity College London · GBUniversity of Glasgow · GBUniversity of Manchester · GB

Funding

Department of Health EME/13/50/17Efficacy and Mechanism Evaluation Programme 13/50/17 APRICOTMedical Research Council MC_PC_14119Medical Research Council MC_PC_15059Medical Research Council MR/N005872/1
6 · The paper itself

Abstract

backgroundCurrent treatment options for Palmoplantar Pustulosis (PPP), a debilitating chronic skin disease which affects the hands and feet, are limited. The Anakinra for Pustular psoriasis: Response in a Controlled Trial (APRICOT) aims to determine the efficacy of anakinra in the treatment of PPP. This article describes the statistical analysis plan for the final analysis of this two-staged trial, which was determined prior to unblinding and database lock. This is an update to the published protocol and stage one analysis plan.

methodsAPRICOT is a randomised, double-blind, placebo-controlled trial of anakinra versus placebo, with two stages and an adaptive element. Stage one compared treatment arms to ensure proof-of-concept and determined the primary outcome for stage two of the trial. The primary outcome was selected to be the change in Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) at 8 weeks. Secondary outcomes include other investigator-assessed efficacy measures of disease severity, participant-reported measures of efficacy and safety measures. This manuscript describes in detail the outcomes, sample size, general analysis principles, the pre-specified statistical analysis plan for each of the outcomes, the handling of missing outcome data and the planned sensitivity and supplementary analyses for the second stage of the APRICOT trial. DISCUSSION: This statistical analysis plan was developed in compliance with international trial guidelines and is published to increase transparency of the trial analysis. The results of the trial analysis will indicate whether anakinra has a role in the treatment of PPP.

trial registrationISCRTN, ISCRTN13127147. Registered on 1 August 2016. EudraCT Number 2015-003600-23. Registered on 1 April 2016.

Indexed as

Adaptive Clinical Trials as TopicAntirheumatic AgentsDouble-Blind MethodFemaleFollow-Up StudiesHumansInterleukin 1 Receptor Antagonist ProteinMaleMedication AdherencePatient Reported Outcome MeasuresPsoriasisQuality of LifeRandomized Controlled Trials as TopicSeverity of Illness IndexTreatment OutcomeAntirheumatic AgentsInterleukin 1 Receptor Antagonist ProteinPsoriasis, Palmoplantar pustulosis, Randomised controlled trial, Anakinra, Adaptive trial,Statistical analysis plan

Identifiers

PMID32041649
PMCPMC7011285
OpenAlexW3007220632

What OpenQuestion holds

Textmetadata
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.