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
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
<strong>Protocol</strong> Version 3 14/01/2013<br />
2.2 Trial design<br />
This is a s<strong>in</strong>gle-bl<strong>in</strong>ded, randomised cl<strong>in</strong>ical trial. Patients recruited to this <strong>study</strong> will undergo a<br />
synovial biopsy at basel<strong>in</strong>e, prior to randomisation. Patients will subsequently be stratified <strong>in</strong> to 3<br />
groups (B Cell Poor, B Cell Rich, Germ<strong>in</strong>al Centres (GC) Rich)accord<strong>in</strong>g to the follow<strong>in</strong>g B-cell<br />
score prior to therapeutic <strong>in</strong>tervention.<br />
2.3 Study Scheme Diagram<br />
Study: R4RA EudraCT: 2012-002535-28 16 / 34