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

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! 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 REC reference: 12/WA/0307 EudraCT reference: 2012-002535-28 Protocol Version: 2 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 Protocol Date: 18 / OCTOBER / 2012 Study: R4RA EudraCT: 2012-002535-28 2 / 34
Chief Investigator Agreement Page The clinical study as detailed within this research protocol (Version 2, dated 18/OCTOBER/2012), 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: Protocol Title : A Randomised, open
Page 5 and 6: Contact details: CPTU Contact: Beno
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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
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Page 17 and 18: ! 3 STUDY POPULATION 3.1 Number of
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Page 21 and 22: 4.4 IMP Stability Rituximab RIituxi
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Protocol Title : A Randomised, open labelled study in anti ... - EME

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