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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STUDY SUMMARY/SYNOPSIS<br />
TITLE Develop<strong>in</strong>g a novel, biopsy-based diagnostic for patient<br />
stratification: “A <strong>Randomised</strong>, <strong>open</strong> <strong>labelled</strong> <strong>study</strong><strong>in</strong> <strong>anti</strong>-<br />
TNFa <strong>in</strong>adequate responders to <strong>in</strong>vestigate the<br />
mechanisms for Response - Resistance to Rituximab<br />
versus Tocilizumab <strong>in</strong> RA (R4-RA)”.<br />
SHORT TITLE R4-RA<br />
<strong>Protocol</strong> Version<br />
Number and Date<br />
<strong>Protocol</strong> 1, 18/08/2012<br />
Methodology Type of <strong>study</strong>: s<strong>in</strong>gle-bl<strong>in</strong>d, randomised controlled cl<strong>in</strong>ical<br />
trial<br />
Study Duration 4 years<br />
Study Centre Barts and The Royal London NHS Trust<br />
Objectives This <strong>study</strong> will aim to develop a diagnostic tool<br />
(immunohistochemical analysis of synovial tissue) for<br />
patient stratification <strong>in</strong>to responsive/non-responsive<br />
categories with respect to Rituximab therapy <strong>in</strong> patients<br />
who have had an <strong>in</strong>adequate response to <strong>anti</strong>-TNF<br />
therapy. Specifically, can a diagnostic synovial biopsy<br />
show<strong>in</strong>g a B-cell “rich/poor pathotype” def<strong>in</strong>e specific<br />
disease responsive/resistant subsets for patient<br />
stratification and help rationalize biologic drug choice?<br />
Phase of the Trial Phase IV <strong>study</strong><br />
Number of Subjects/ 180<br />
Patients<br />
Ma<strong>in</strong> Inclusion Criteria Patients will be recruited with active RA:<br />
1. Patients who have failed <strong>anti</strong>-TNF therapy<br />
(<strong>in</strong>adequate responders – ir).<br />
2. Patients who are seropositive for Rheumatoid<br />
Factor and/ or Anti-CCP <strong>anti</strong>bodies.<br />
3. Who are eligible for Rituximab therapy accord<strong>in</strong>g<br />
NICE guidl<strong>in</strong>es<br />
4. Patients should be receiv<strong>in</strong>g a stable dose<br />
Methotrexate for at least 4 weeks prior to<br />
screen<strong>in</strong>g.<br />
5. 2010 ACR / EULAR Rheumatoid Arthritis<br />
classification criteria for a diagnosis of<br />
Rheumatoid Arthritis.<br />
6. Over 18 years of age<br />
7. Patient must be capable of giv<strong>in</strong>g <strong>in</strong>formed<br />
consent<br />
8. Will<strong>in</strong>gness and ability to comply with scheduled<br />
visits, treatment plans and laboratory tests and<br />
other <strong>study</strong> procedures<br />
Study: R4RA EudraCT: 2012-002535-28 6 / 34