Protocol Title : A Randomised, open labelled study in anti ... - EME

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A baseline synovial biopsy is mandatory as part of the patient stratification process however
subsequent synovial biopsies will remain optional. Patients not receiving a subsequent biopsy at 6
months will continue within the study as per protocol.
The initial biopsy visit may be combined with completion of the study screening visit if all screening
procedures are available and the patients is eligible for enrolment into the study. Patients must be
randomised prior to the biopsy being performed. If the completion of the screening and biopsy visit
occur on the same day, there is no need to repeat the procedures for vital signs, Pregnancy test,
DAS28, CDAI, VAS pain score. The results for theses procedures should be duplicated and
entered into both the screening and biopsy visit on the eCRF.
5.8 Baseline visit
Patients at baseline will have the following assessments:
• Clinical examination
• Clinical Disease Activity Index (CDAI)
• Disease activity core data set, DAS28
• Physical function using the Health Assessment Questionnaire
• Pain score using the VAS system
• Physical function (HAQ)
• SF-36
• FACIT - Fatigue Questionnaire
• Cardiovascular risk assessment
• Vital signs
• Adverse reactions
• Concomitant medication
• Study specific and routine bloods
• Pregnancy test in women of child bearing age.
• Plain X-rays of hands and feet
• Ultrasound joint examination
Patients will receive either Tocilizumab or Rituximab at their baseline visit depending upon
randomisation. All assessments should be performed prior to commencement of infusion of
therapy.
5.9 Follow up visits
Patients will be monitored on a monthly basis as shown in the study visit schedule (Section 5.5).
The DAS 28, a validated composited end point, will be used to assess response to therapy as the
primary outcome measure. The Health Assessment Questionnaire and SF-36 will be used to
gauge functional ability and improvement in other aspects of the patients life e.g. vitality, emotional
role functioning, social role functioning and mental health.
The principal investigator (or deputy) will be responsible for collecting, recording and
reporting data on adverse events, drug therapy and direct NHS costs (investigations, routine
blood monitoring, community and outpatient appointments, and inpatient stays) at each study
visit.
All joint assessments will be performed by the blinded study nurse. Data will be collected as
follows:
• Demographic data including age, gender
• Diagnostic information including the 1987 criteria of the ACR classification criteria for a
diagnosis of RA and the EULAR / ACR joint classification criteria 2010, titre of rheumatoid
factor and disease duration
• Disease activity including ACR/EULAR core set, DAS28
• Clinical Disease Activity Index (CDAI)
• Physical function using the Health Assessment Questionnaire
Study: R4RA EudraCT: 2012-002535-28 23 / 34