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

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Protocol Version 3 14/01/2013 18. Haupl T, Stuhlmuller B, Grutzkau A, Radbruch A, Burmester GR. Does gene expression analysis inform us in rheumatoid arthritis? Annals of the rheumatic diseases 2010;69 Suppl 1:i37-42. 19. van Baarsen LG, Wijbrandts CA, Gerlag DM, et al. Pharmacogenomics of infliximab treatment using peripheral blood cells of patients with rheumatoid arthritis. Genes Immun 2010;11:622-9. 20. Kaufmann M, Pusztai L. Use of standard markers and incorporation of molecular markers into breast cancer therapy: Consensus recommendations from an International Expert Panel. Cancer 2011;117:1575-82. Study: R4RA EudraCT: 2012-002535-28 38 / 34
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Protocol Title : A Randomised, open
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Chief Investigator Agreement Page T
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Contact details: CPTU Contact: Beno
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Statistical Methodology and Analysi
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Contents ! 1. INTRODUCTION 11 1.1.
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1 INTRODUCTION ! 1.1 Background Rhe
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1.3 Clinical Data 1.3.1 Rituximab C
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! response is associated with absen
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! 3 STUDY POPULATION 3.1 Number of
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! • Slowly add the total volume o
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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.
Page 31 and 32: ! 7.2 Secondary Endpoint Efficacy A
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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