Evidence map›Paper›PMID 36637209›Full record

Trial reportRheumatology (Oxford, England)2023

A Phase II randomized controlled trial of oral prednisolone in early diffuse cutaneous systemic sclerosis (PRedSS).

Deborah J Griffiths-Jones, Yvonne Sylvestre Garcia, W David Ryder, John D Pauling, Frances Hall, Peter Lanyon, Smita Bhat, Karen Douglas, Harsha Gunawardena, Mohammed Akil and 12 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Rheumatology (Oxford, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03708718 (A Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis), which is not on this map. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
2.8field-weighted citation impact, top 10% 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.

NCT03708718 phase2completednot on this map

A Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19)

TypeinterventionalSponsorProf. Ariane herrickRan2017 to 2021Enrolled35ConditionsSystemic SclerosisArmsPrednisolone 5 mg, Placebo oral capsule, From August 2020 'no additional treatment'
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Trial
  5. Review
  6. Review
  7. 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

22 authors at 16 institutions in 1 country.

Deborah J Griffiths-JonesDivision of Musculoskeletal and Dermatological Sciences, The University of Manchester, Manchester, UK.
Yvonne Sylvestre GarciaManchester Clinical Trials Unit, The University of Manchester, Manchester, UK.
W David RyderManchester Clinical Trials Unit, The University of Manchester, Manchester, UK.
John D PaulingDepartment of Rheumatology, Royal United Hospitals Bath NHS Trust, Bath, UK.ORCID 0000-0002-2793-2364
Frances HallDepartment of Rheumatology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Peter LanyonDepartment of Rheumatology, Nottingham University Hospitals NHS Trust, and Lifespan and Population Health, School of Medicine, University of Nottingham, Nottingham, UK.
Smita BhatDepartment of Rheumatology, Ninewells Hospital and Medical School, Dundee, UK.
Karen DouglasDepartment of Rheumatology, Dudley Group NHSFT, Dudley, UK.
Harsha GunawardenaRheumatology Department, North Bristol NHS Trust, and Academic Rheumatology, University of Bristol, Bristol, UK.
Mohammed AkilDepartment of Rheumatology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Marina AndersonLancaster Medical School, Faculty of Health and Medicine, Lancaster University, Lancaster and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.
Bridget GriffithsDepartment of Rheumatology, Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Francesco Del GaldoNIHR Biomedical Research Centre and Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.ORCID 0000-0002-8528-2283
Hazem YoussefDepartment of Rheumatology, Aberdeen Royal Infirmary, Aberdeen, UK.
Rajan MadhokCentre for Rheumatic Diseases, Glasgow Royal Infirmary, Glasgow, UK.
Barbara ArthursDivision of Musculoskeletal and Dermatological Sciences, The University of Manchester, Manchester, UK.
Maya BuchDivision of Musculoskeletal and Dermatological Sciences, The University of Manchester, Manchester, UK.ORCID 0000-0002-8962-5642
Kim FligelstoneRoyal Free Hospital, London, UK.
Mohammed ZubairResearch Governance and Integrity, The University of Manchester, Manchester, UK.
Justin C MasonNational Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, UK.
Christopher P DentonCentre for Rheumatology, UCL Division of Medicine, Royal Free Campus, London, UK.ORCID 0000-0003-3975-8938
Ariane L HerrickNIHR Manchester Biomedical Research Centre, Central Manchester NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.ORCID 0000-0003-4941-7926
University of Manchester · GBManchester Academic Health Science Centre · GBThe Royal Free Hospital · GBAberdeen Royal Infirmary · GBCambridge University Hospitals NHS Foundation Trust · GBDudley Group NHS Foundation Trust · GBGlasgow Royal Infirmary · GBHammersmith Hospital · GBLancaster University · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GBNinewells Hospital · GBNorth Bristol NHS Trust · GBNottingham University Hospitals NHS Trust · GBRoyal United Hospital Bath NHS Trust · GBSheffield Teaching Hospitals NHS Foundation Trust · GBUniversity of Leeds · GB

Funding

Department of HealthVersus Arthritis 21021
6 · The paper itself

Abstract

objectivesAlthough the painful and disabling features of early diffuse cutaneous SSc (dcSSc) have an inflammatory basis and could respond to corticosteroids, corticosteroids are a risk factor for scleroderma renal crisis. Whether or not they should be prescribed is therefore highly contentious. Our aim was to examine safety and efficacy of moderate-dose prednisolone in early dcSSc.

methodsPRedSS set out as a Phase II, multicentre, double-blind randomized controlled trial, converted to open-label during the Covid-19 pandemic. Patients were randomized to receive either prednisolone (∼0.3 mg/kg) or matching placebo (or no treatment during open-label) for 6 months. Co-primary endpoints were the HAQ Disability Index (HAQ-DI) and modified Rodnan skin score (mRSS) at 3 months. Over 20 secondary endpoints included patient reported outcome measures reflecting pain, itch, fatigue, anxiety and depression, and helplessness. Target recruitment was 72 patients.

resultsThirty-five patients were randomized (17 prednisolone, 18 placebo/control). The adjusted mean difference between treatment groups at 3 months in HAQ-DI score was -0.10 (97.5% CI: -0.29, 0.10), P = 0.254, and in mRSS -3.90 (97.5% CI: -8.83, 1.03), P = 0.070, both favouring prednisolone but not significantly. Patients in the prednisolone group experienced significantly less pain (P = 0.027), anxiety (P = 0.018) and helplessness (P = 0.040) than control patients at 3 months. There were no renal crises, but sample size was small.

conclusionPRedSS was terminated early primarily due to the Covid-19 pandemic, and so was underpowered. Therefore, interpretation must be cautious and results considered inconclusive, indicating the need for a further randomized trial.

trial registrationClinicalTrials.gov, https://clinicaltrials.gov, NCT03708718.

Indexed as

COVID-19Scleroderma, DiffuseDouble-Blind MethodHumansPainPandemicsPrednisoloneTreatment OutcomePrednisolonecorticosteroidsdisabilitypainrandomized controlled trialSSc

Identifiers

PMID36637209
PMCPMC10473191
OpenAlexW4315928065

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.