Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
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<strong>Protocol</strong> Version 3 14/01/2013<br />
participation or <strong>study</strong> drug adm<strong>in</strong>istration, or which, <strong>in</strong> the judgment of the <strong>in</strong>vestigator, would<br />
make the patient <strong>in</strong>appropriate for entry <strong>in</strong>to this <strong>study</strong><br />
The PI reserves the right to exclude patients at his centre if they have concerns regard<strong>in</strong>g<br />
compliance with the <strong>study</strong> procedures or any other aspect of the <strong>study</strong> eligibility not necessarily<br />
limited to the above exclusion criteria.<br />
3.4 Criteria for Premature Withdrawal<br />
3.4.1 Subject Withdrawal Criteria<br />
A subject may withdraw from the <strong>study</strong> at any time at his/her own request, or may be withdrawn at<br />
any time at the discretion of the <strong>in</strong>vestigator for safety, behavioral or adm<strong>in</strong>istrative reasons.<br />
3.4.2 Subject Withdrawal Procedures<br />
If subjects prematurely discont<strong>in</strong>ue the <strong>study</strong>, additional subjects may be enrolled as<br />
replacement subjects and assigned to the same treatment sequence at the discretion of the<br />
Sponsor. A f<strong>in</strong>al visit assessment will be made if the patient agrees.<br />
4 INVESTIGATIONAL MEDICINAL PRODUCT<br />
4.1 List and def<strong>in</strong>ition of each IMPs<br />
Rituximab<br />
Rituximab is a genetically eng<strong>in</strong>eered chimeric mouse/human monoclonal <strong>anti</strong>body represent<strong>in</strong>g a<br />
glycosylated immunoglobul<strong>in</strong> with human IgG1 constant regions and mur<strong>in</strong>e light-cha<strong>in</strong> and heavycha<strong>in</strong><br />
variable region sequences.<br />
Tocilizumab<br />
Tocilizumab humanised IgG1 monoclonal <strong>anti</strong>body aga<strong>in</strong>st the human <strong>in</strong>terleuk<strong>in</strong>-6 (IL-6) receptor<br />
produced <strong>in</strong> Ch<strong>in</strong>ese hamster ovary (CHO) cells by recomb<strong>in</strong>ant DNA technology<br />
4.2 Formulation of IMP<br />
Rituximab<br />
Rituximab is available as 50ml s<strong>in</strong>gle-use vials conta<strong>in</strong><strong>in</strong>g 500mg rituximab for <strong>in</strong>fusion (10mg/ml)<br />
Rituximab is a clear, colourless liquid<br />
Tocilizumab<br />
Tocilizumab is available <strong>in</strong> 20mg/ml vials <strong>in</strong> a concentrate for <strong>in</strong>travenous <strong>in</strong>fusion. The vials are<br />
available <strong>in</strong> 4ml (80mg), 10ml (200mg), and 20ml (400mg).<br />
4.3 IMP Supply<br />
Rituximab<br />
Rituximab will be prescribed accord<strong>in</strong>g to NICE guidel<strong>in</strong>es and thus will be sourced from the NHS<br />
supply at each site.<br />
Tocilizumab<br />
Tocilizumab will be prescribed a accord<strong>in</strong>g to NICE guidel<strong>in</strong>es and thus will be sourced from the<br />
NHS supply at each site.<br />
4.4 Prescription of IMP<br />
Rituximab<br />
Rituximab will be prescribed by a physician as a member of the <strong>study</strong> team, us<strong>in</strong>g standardised<br />
prescription forms. A copy of all prescription forms will be provided to the monitor.<br />
Study: R4RA EudraCT: 2012-002535-28 18 / 34