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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A basel<strong>in</strong>e synovial biopsy is mandatory as part of the patient stratification process however<br />
subsequent synovial biopsies will rema<strong>in</strong> optional. Patients not receiv<strong>in</strong>g a subsequent biopsy at 6<br />
months will cont<strong>in</strong>ue with<strong>in</strong> the <strong>study</strong> as per protocol.<br />
The <strong>in</strong>itial biopsy visit may be comb<strong>in</strong>ed with completion of the <strong>study</strong> screen<strong>in</strong>g visit if all screen<strong>in</strong>g<br />
procedures are available and the patients is eligible for enrolment <strong>in</strong>to the <strong>study</strong>. Patients must be<br />
randomised prior to the biopsy be<strong>in</strong>g performed. If the completion of the screen<strong>in</strong>g and biopsy visit<br />
occur on the same day, there is no need to repeat the procedures for vital signs, Pregnancy test,<br />
DAS28, CDAI, VAS pa<strong>in</strong> score. The results for theses procedures should be duplicated and<br />
entered <strong>in</strong>to both the screen<strong>in</strong>g and biopsy visit on the eCRF.<br />
5.8 Basel<strong>in</strong>e visit<br />
Patients at basel<strong>in</strong>e will have the follow<strong>in</strong>g assessments:<br />
• Cl<strong>in</strong>ical exam<strong>in</strong>ation<br />
• Cl<strong>in</strong>ical Disease Activity Index (CDAI)<br />
• Disease activity core data set, DAS28<br />
• Physical function us<strong>in</strong>g the Health Assessment Questionnaire<br />
• Pa<strong>in</strong> score us<strong>in</strong>g the VAS system<br />
• Physical function (HAQ)<br />
• SF-36<br />
• FACIT - Fatigue Questionnaire<br />
• Cardiovascular risk assessment<br />
• Vital signs<br />
• Adverse reactions<br />
• Concomitant medication<br />
• Study specific and rout<strong>in</strong>e bloods<br />
• Pregnancy test <strong>in</strong> women of child bear<strong>in</strong>g age.<br />
• Pla<strong>in</strong> X-rays of hands and feet<br />
• Ultrasound jo<strong>in</strong>t exam<strong>in</strong>ation<br />
Patients will receive either Tocilizumab or Rituximab at their basel<strong>in</strong>e visit depend<strong>in</strong>g upon<br />
randomisation. All assessments should be performed prior to commencement of <strong>in</strong>fusion of<br />
therapy.<br />
5.9 Follow up visits<br />
Patients will be monitored on a monthly basis as shown <strong>in</strong> the <strong>study</strong> visit schedule (Section 5.5).<br />
The DAS 28, a validated composited end po<strong>in</strong>t, will be used to assess response to therapy as the<br />
primary outcome measure. The Health Assessment Questionnaire and SF-36 will be used to<br />
gauge functional ability and improvement <strong>in</strong> other aspects of the patients life e.g. vitality, emotional<br />
role function<strong>in</strong>g, social role function<strong>in</strong>g and mental health.<br />
The pr<strong>in</strong>cipal <strong>in</strong>vestigator (or deputy) will be responsible for collect<strong>in</strong>g, record<strong>in</strong>g and<br />
report<strong>in</strong>g data on adverse events, drug therapy and direct NHS costs (<strong>in</strong>vestigations, rout<strong>in</strong>e<br />
blood monitor<strong>in</strong>g, community and outpatient appo<strong>in</strong>tments, and <strong>in</strong>patient stays) at each <strong>study</strong><br />
visit.<br />
All jo<strong>in</strong>t assessments will be performed by the bl<strong>in</strong>ded <strong>study</strong> nurse. Data will be collected as<br />
follows:<br />
• Demographic data <strong>in</strong>clud<strong>in</strong>g age, gender<br />
• Diagnostic <strong>in</strong>formation <strong>in</strong>clud<strong>in</strong>g the 1987 criteria of the ACR classification criteria for a<br />
diagnosis of RA and the EULAR / ACR jo<strong>in</strong>t classification criteria 2010, titre of rheumatoid<br />
factor and disease duration<br />
• Disease activity <strong>in</strong>clud<strong>in</strong>g ACR/EULAR core set, DAS28<br />
• Cl<strong>in</strong>ical Disease Activity Index (CDAI)<br />
• Physical function us<strong>in</strong>g the Health Assessment Questionnaire<br />
Study: R4RA EudraCT: 2012-002535-28 23 / 34