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

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Statistician Agreement Page The clinical study as detailed within this research protocol (Version 2, dated 18/JULY/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. Statistician Name: Professor Peter Sasieni Professor of Biostatistics & Cancer Epidemiology Deputy Director, Centre for Cancer Prevention Site: Wolfson Institute of Preventive Medicine Signature and Date: ! Barts and The London School of Medicine and Dentistry Charterhouse Square London EC1M 6BQ Study: R4RA EudraCT: 2012-002535-28 4 / 34
Contact details: CPTU Contact: Benoit Aigret Tel: 02078823509 Email: b.aigret@qmul.ac.uk Address: Wolfson Institute of Preventive Medicine Barts and The London School of Medicine and Dentistry Charterhouse Square London EC1M 6BQ Central Laboratory 1 Contact: Prof. J. Martin Tel: 0203 246 0198 Email: j.e.martin@qmul.ac.uk Address: Barts Health NHS Trust c/o specimen collection 3rd floor pharmacy and pathology building 80 Newark St Whitechapel, London E1 2ES Central Laboratory 2 Contact: Dr. Rebecca Hands (Laboratory Manager) Tel: 0207 882 8194 Email: r.e.hands@qmul.ac.uk Address: Centre for Experimental Medicine and Rheumatology 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 5 / 34
Page 1 and 2: Protocol Title : A Randomised, open
Page 3: Chief Investigator Agreement Page T
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
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Page 21 and 22: 4.4 IMP Stability Rituximab RIituxi
Page 23 and 24: ! A baseline synovial biopsy is man
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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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