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

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! components, the erosion score and joint space narrowing score. Inhibition of joint structural damage was shown with significantly less radiographic progression in patients receiving tocilizumab compared to control. In the open-label extension of this study the inhibition of progression of structural joint damage in tocilizumab plus MTX-treated patients was maintained in the second year of treatment. The mean change from baseline at week 104 in total Sharp-Genant score was significantly lower for patients randomised to tocilizumab plus MTX (p
! response is associated with absence/scarce B cells (chi squared p
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: 1.3 Clinical Data 1.3.1 Rituximab C
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
Page 27 and 28: ! (the former usually precedes the
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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