Protocol Title : A Randomised, open labelled study in anti ... - EME

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Protocol Version 3 14/01/2013 TITLE OF THE PROTOCOL: Developing a novel, biopsy-based diagnostic for patient stratification: “A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA”. Short title/Acronym: R4-RA Sponsor: Barts Health NHS Trust Representative of the Sponsor: Gerry Leonard Head of Resources Joint R&D Office 5 Walden Street London E1 2EF Phone: 020 7882 7260 Email: sponsorsrep@bartshealth.nhs.uk Study: R4RA EudraCT: 2012-002535-28 2 / 34
Protocol Version 3 14/01/2013 Chief Investigator Agreement Page The clinical study as detailed within this research protocol (Version 3, dated 14/JANUARY/2013), or any subsequent amendments, involves the use of an investigational medicinal product and will be conducted in accordance with the Research Governance Framework for Health & Social Care (2005), the World Medical Association Declaration of Helsinki (1996), Principles of ICH-GCP, and the current regulatory requirements, as detailed in the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK S.I. 2004/1031) and any subsequent amendments of the clinical trial regulations. Chief Investigator Name: Professor Costantino Pitzalis Professor of Experimental Medicine and Rheumatology Director Musculoskeletal Clinical Academic Unit Barts Health NHS Trust Chief Investigator Site: Centre for Experimental Medicine and Rheumatology Signature and Date: 2nd Floor, John Vane Science Centre William Harvey Research Institute Barts and the London School of Medicine and Dentistry Charterhouse Square London EC1M 6BQ Study: R4RA EudraCT: 2012-002535-28 3 / 34
Page 1 and 2: Protocol Title : A Randomised, open
Page 3 and 4: Chief Investigator Agreement Page T
Page 5 and 6: Contact details: CPTU Contact: Beno
Page 7 and 8: Statistical Methodology and Analysi
Page 9 and 10: Contents ! 1. INTRODUCTION 11 1.1.
Page 11 and 12: 1 INTRODUCTION ! 1.1 Background Rhe
Page 13 and 14: 1.3 Clinical Data 1.3.1 Rituximab C
Page 15 and 16: ! response is associated with absen
Page 17 and 18: ! 3 STUDY POPULATION 3.1 Number of
Page 19 and 20: ! • Slowly add the total volume o
Page 21 and 22: 4.4 IMP Stability Rituximab RIituxi
Page 23 and 24: ! A baseline synovial biopsy is man
Page 25 and 26: ! Small response - CDAI50 ≥ 50% i
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Page 29 and 30: ! 6.3 Investigators Assessment 6.3.
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Page 33 and 34: ! completed screening procedures an
Page 35 and 36: 9 TRIAL COMMITTEES ! 9.1 Trial Mana
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Protocol Title : A Randomised, open labelled study in anti ... - EME

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