Clinical and cost-effectiveness of oral versus intramuscular glucocorticoids in rheumatoid arthritis: protocol for a multicentre randomised controlled trial with economic evaluation and qualitative sub-study (LEADER trial).
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| Title: | Clinical and cost-effectiveness of oral versus intramuscular glucocorticoids in rheumatoid arthritis: protocol for a multicentre randomised controlled trial with economic evaluation and qualitative sub-study (LEADER trial). |
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| Authors: | Cook JA; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, England, UK., Wilson N; Department of Rheumatology, King's College Hospital NHS Foundation Trust, London, UK.; Centre for Rheumatic Diseases, Kings College London, London, England, UK., Wilkins K; Centre for Rheumatic Diseases, Kings College London, London, England, UK., Staniland K; Centre for Genetics and Genomics, Centre for Musculoskeletal Research, Division of Musculoskeletal & Dermatological Sciences, The University of Manchester, Manchester, UK., Ekang I; Centre for Genetics and Genomics, Centre for Musculoskeletal Research, Division of Musculoskeletal & Dermatological Sciences, The University of Manchester, Manchester, UK., Azmi S; Diabetes, Endocrinology and Metabolism, Manchester University NHS Foundation Trust, Manchester, Division of Cardiovascular Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, England, UK., Heaney L; Wellcome-Wolfson Institute for Experimental Medicine School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland, UK., Gavan SP; Manchester Centre for Health Economics, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK., Elliott RA; Manchester Centre for Health Economics, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK., Wilson RJ; Department of Rheumatology, University College London Hospitals NHS Foundation Trust, London, UK., Calvert C; Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK., Francis A; Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK., Williams JAE; Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK., Turner A; Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK., Zimmermann A; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, England, UK., Richards D; Department of Medicine, University of Cambridge, Cambridge, UK., Barton A; Centre for Genetics and Genomics, Centre for Musculoskeletal Research, Division of Musculoskeletal & Dermatological Sciences, The University of Manchester, Manchester, UK.; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, England, UK., Bluett J; Centre for Genetics and Genomics, Centre for Musculoskeletal Research, Division of Musculoskeletal & Dermatological Sciences, The University of Manchester, Manchester, UK james.bluett@manchester.ac.uk.; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, England, UK. |
| Corporate Authors: | LEADER trial network |
| Source: | BMJ open [BMJ Open] 2026 Jul 10; Vol. 16 (7), pp. e119885. Date of Electronic Publication: 2026 Jul 10. |
| Publication Type: | Journal Article; Clinical Trial Protocol |
| Journal Info: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 42431665 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Clinical and cost-effectiveness of oral versus intramuscular glucocorticoids in rheumatoid arthritis: protocol for a multicentre randomised controlled trial with economic evaluation and qualitative sub-study (LEADER trial). – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Cook+JA%22">Cook JA</searchLink>; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, England, UK.<br /><searchLink fieldCode="AU" term="%22Wilson+N%22">Wilson N</searchLink>; Department of Rheumatology, King's College Hospital NHS Foundation Trust, London, UK.; Centre for Rheumatic Diseases, Kings College London, London, England, UK.<br /><searchLink fieldCode="AU" term="%22Wilkins+K%22">Wilkins K</searchLink>; Centre for Rheumatic Diseases, Kings College London, London, England, UK.<br /><searchLink fieldCode="AU" term="%22Staniland+K%22">Staniland K</searchLink>; Centre for Genetics and Genomics, Centre for Musculoskeletal Research, Division of Musculoskeletal & Dermatological Sciences, The University of Manchester, Manchester, UK.<br /><searchLink fieldCode="AU" term="%22Ekang+I%22">Ekang I</searchLink>; Centre for Genetics and Genomics, Centre for Musculoskeletal Research, Division of Musculoskeletal & Dermatological Sciences, The University of Manchester, Manchester, UK.<br /><searchLink fieldCode="AU" term="%22Azmi+S%22">Azmi S</searchLink>; Diabetes, Endocrinology and Metabolism, Manchester University NHS Foundation Trust, Manchester, Division of Cardiovascular Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, England, UK.<br /><searchLink fieldCode="AU" term="%22Heaney+L%22">Heaney L</searchLink>; Wellcome-Wolfson Institute for Experimental Medicine School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland, UK.<br /><searchLink fieldCode="AU" term="%22Gavan+SP%22">Gavan SP</searchLink>; Manchester Centre for Health Economics, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.<br /><searchLink fieldCode="AU" term="%22Elliott+RA%22">Elliott RA</searchLink>; Manchester Centre for Health Economics, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.<br /><searchLink fieldCode="AU" term="%22Wilson+RJ%22">Wilson RJ</searchLink>; Department of Rheumatology, University College London Hospitals NHS Foundation Trust, London, UK.<br /><searchLink fieldCode="AU" term="%22Calvert+C%22">Calvert C</searchLink>; Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Francis+A%22">Francis A</searchLink>; Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Williams+JAE%22">Williams JAE</searchLink>; Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Turner+A%22">Turner A</searchLink>; Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Zimmermann+A%22">Zimmermann A</searchLink>; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, England, UK.<br /><searchLink fieldCode="AU" term="%22Richards+D%22">Richards D</searchLink>; Department of Medicine, University of Cambridge, Cambridge, UK.<br /><searchLink fieldCode="AU" term="%22Barton+A%22">Barton A</searchLink>; Centre for Genetics and Genomics, Centre for Musculoskeletal Research, Division of Musculoskeletal & Dermatological Sciences, The University of Manchester, Manchester, UK.; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, England, UK.<br /><searchLink fieldCode="AU" term="%22Bluett+J%22">Bluett J</searchLink>; Centre for Genetics and Genomics, Centre for Musculoskeletal Research, Division of Musculoskeletal & Dermatological Sciences, The University of Manchester, Manchester, UK james.bluett@manchester.ac.uk.; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, England, UK. – Name: AuthorCorporate Label: Corporate Authors Group: Au Data: <searchLink fieldCode="CA" term="%22LEADER+trial+network%22">LEADER trial network</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101552874%22">BMJ open</searchLink> [BMJ Open] 2026 Jul 10; Vol. 16 (7), pp. e119885. <i>Date of Electronic Publication: </i>2026 Jul 10. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Clinical Trial Protocol – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BMJ+Publishing+Group+Ltd%22">BMJ Publishing Group Ltd </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101552874 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2044-6055 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2220446055%22">20446055 </searchLink><i>NLM ISO Abbreviation: </i>BMJ Open <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=42431665 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1136/bmjopen-2026-119885 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: e119885 Titles: – TitleFull: Clinical and cost-effectiveness of oral versus intramuscular glucocorticoids in rheumatoid arthritis: protocol for a multicentre randomised controlled trial with economic evaluation and qualitative sub-study (LEADER trial). Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Cook JA – PersonEntity: Name: NameFull: Wilson N – PersonEntity: Name: NameFull: Wilkins K – PersonEntity: Name: NameFull: Staniland K – PersonEntity: Name: NameFull: Ekang I – PersonEntity: Name: NameFull: Azmi S – PersonEntity: Name: NameFull: Heaney L – PersonEntity: Name: NameFull: Gavan SP – PersonEntity: Name: NameFull: Elliott RA – PersonEntity: Name: NameFull: Wilson RJ – PersonEntity: Name: NameFull: Calvert C – PersonEntity: Name: NameFull: Francis A – PersonEntity: Name: NameFull: Williams JAE – PersonEntity: Name: NameFull: Turner A – PersonEntity: Name: NameFull: Zimmermann A – PersonEntity: Name: NameFull: Richards D – PersonEntity: Name: NameFull: Barton A – PersonEntity: Name: NameFull: Bluett J IsPartOfRelationships: – BibEntity: Dates: – D: 10 M: 07 Text: 2026 Jul 10 Type: published Y: 2026 Identifiers: – Type: issn-electronic Value: 2044-6055 Numbering: – Type: volume Value: 16 – Type: issue Value: 7 Titles: – TitleFull: BMJ open Type: main |
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