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 />
a - IGRA may not be performed depend<strong>in</strong>g upon local guidel<strong>in</strong>es with respect to Latent TB screen<strong>in</strong>g for Rituximab and Tocilizumab.<br />
b - a pregnancy test will be performed at each <strong>study</strong> visit for female patients of child bear<strong>in</strong>g age irrespective of the use of contraceptive methods.<br />
c - a basel<strong>in</strong>e synovial biopsy is mandatory as part of the patient stratification process however subsequent synovial biopsies will require consent and will<br />
rema<strong>in</strong> optional. Patients not receiv<strong>in</strong>g a subsequent biopsy will cont<strong>in</strong>ue with<strong>in</strong> the <strong>study</strong> as per protocol.<br />
5.6 Screen<strong>in</strong>g<br />
Dur<strong>in</strong>g the screen<strong>in</strong>g visit, written <strong>in</strong>formed consent will be obta<strong>in</strong>ed from all patients by the<br />
pr<strong>in</strong>cipal <strong>in</strong>vestigator or his/her designee before any protocol-specific procedure is performed.<br />
Study details, risks and benefits will all be reviewed and subjects will be encouraged to ask<br />
questions and clarify any concerns.<br />
A chest radiograph will be performed prior to start<strong>in</strong>g any biological therapy, <strong>in</strong> keep<strong>in</strong>g with local<br />
guidel<strong>in</strong>es (unless a chest x-ray had been done <strong>in</strong> the preced<strong>in</strong>g 3 months and the patient has not<br />
had any pulmonary symptoms s<strong>in</strong>ce then).<br />
5.7 Biopsy visit<br />
Patients will receive a synovial biopsy between 1 to 3 weeks prior to their basel<strong>in</strong>e visit. Patients<br />
will have the follow<strong>in</strong>g assessments recorded prior to the synovial biopsy at this visit:<br />
• DAS 28<br />
• CDAI<br />
• Pa<strong>in</strong> VAS<br />
• Rout<strong>in</strong>e cl<strong>in</strong>ical bloods<br />
• Study specific bloods<br />
• Vital signs<br />
• Physical function us<strong>in</strong>g the Health Assessment Questionnaire<br />
• A pregnancy test performed will be performed <strong>in</strong> female patients of child bear<strong>in</strong>g age<br />
• A Ultrasound exam<strong>in</strong>ation of the patients jo<strong>in</strong>ts will be performed prior to the synovial biopsy<br />
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 />
Study: R4RA EudraCT: 2012-002535-28 23 / 34