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

Protocol Version 3 14/01/2013
• FACIT - Fatigue Questionnaire will be assessed at 0, 3, 6, 9 and 12 months
• Adverse reactions
• Concomitant medication
Data will be entered in the electronic CRF by the Investigator or designee who will also coordinate
data validation checks and query resolution.
The study visit schedule for patients recruited to this study, who successfully pass screening, will
commence from the date of first therapeutic infusion. Monthly follow up visits (+/- 1 week).
- Visit: baseline, 1, 2 3, 4, 6, 9, 12, 13 and 14 will also include an US assessment of limited joint set
- Visit: baseline, 12 and 14 will include plain x-rays of both hands and feet
- Visit: Screening, 6 months and 24 months patients will have fasting lipids and cholesterol
measured. As per normal clinical practise, patients with active Rheumatoid arthritis with an
unfavourable lipid / cholesterol profile will be initiated on a statin prior to commencing a biological
agent. Patients will have this profile repeated at 6 months and at the end of the study.
5.9.1 Unscheduled Visits
While patients will be encouraged to attend for the normal visit schedule, unscheduled visits will be
undertaken if the patient is unwell or there are any concerns as to the patient’s progress. This will
constitute data collection as per routine follow up as per visit 3
5.9.2 Withdrawal of Patients
All patients have the right to withdraw consent at any time without prejudice. At the time of
withdrawal of consent, a full efficacy and safety evaluation should be performed if patient consents.
Withdrawn trial subjects will not be replaced.
5.10 Study Outcome Measures
Clinical outcomes
Patients will be assessed clinically using the CDAI (Clinical disease activity index), DAS 28 (CRP),
Health assessment questionnaire and the Short Form 36 as described below.
• CDAI
The components of the CDAI (Clinical disease activity Index) are tender joints (28 joint count), the
number of swollen joints (28 joint count), a Patient global health index (10 cm VAS) and physician
global health index (10 cm VAS). This provides an assessment of Rheumatoid disease activity on
a scale form 0-76.
CDAI scores
High disease activity: >22
Moderate disease activity: 10.1 - 22
Low disease activity 2.8 - 10
Remission < 2.8
Non-responders – CDAI improvement of less than 50% from baseline. Patients may be deemed
non-responders at the discretion of the treating physician if they have achieved a CDAI response
of > 50% from baseline but have not reached low disease activity (CDAI of 10 or less)
Patients showing initial clinical response by 4 months may be subsequently classified as a
secondary failure at subsequent study visits if their change in CDAI from baseline is < 50% at any
subsequent follow up visit.
Patients deemed treatment failures, would be randomised to one of the either therapeutic options.
Failure of a second biological therapy after 4 months follow up, would permit the patient to receive
the last remaining treatment option.
Small response - CDAI50 ≥ 50% improvement form baseline assessment
Moderate response - CDAI ≥ 75% improvement form baseline
Good response – CDAI ≥ 85% improvement form baseline
Study: R4RA EudraCT: 2012-002535-28 25 / 34