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

Protocol Version 3 14/01/2013
Log) of the study drug must be maintained. Accountability will be assessed by maintaining
adequate drug dispensing and return records. This will be delegated to the local site pharmacy.
The IMP will be stored by the local pharmacy.
Accurate records must be kept for each study drug provided. These records must contain the
following:
• Documentation of drug shipments received from the sponsor (date received and
quantity)
• Disposition of unused study drug not dispensed to patient
When the study is completed, the investigator will return all completed Drug Dispensing
Logs to the trial co-ordinator. Also, any unused study drug and Drug Return Records should be
returned to the Monitor. The investigator's copy of the Drug Return Record(s) must accurately
document the return of all study drug supplied.
4.3 Dispensing of IMP
A Drug Dispensing Log will be kept current and will contain the following
information:
• the identification of the patient to whom the study medication was dispensed
• the date[s], quantity of the study medication dispensed to the patient
• the date[s] and quantity of the study medication returned by the patient.
All records and drug supplies must be available for inspection by the Monitor at every
monitoring visit.
When the study is completed, the investigator will return all completed Drug Dispensing
Logs to the monitors.
4.4 IMP Stability
Rituximab
RIituximab solutions for infusion may be stored at 2 -8 o C (36-46 o F) for 24 hours. RIituximab
solutions for infusion have been shown to be stable for an additional 24 hours at room
temperature. However, since Rituximab solutions do not contain a preservative, diluted solutions
should be stored refrigerated (2-8 o C) with temperature log. No incompatibilities between Rituximab
and polyvinylchloride or polyethylene bags have been observed.
Tocilizumab
All Tocilizumab vials must be stored at a controlled temperature of 2-8°C, and handled according
to GMP and GCP procedures. The infusion bag of Tocilizumab in saline may be made up within 24
hours of dosing and must be stored in a refrigerator at 2-8°C, provided the site takes precautions to
prepare the infusion aseptically. A temperature log must be kept, on which the storage temperature
of the Tocilizumab and infusion bags is recorded at least once a day.
4.5 Prior and Concomitant Anit-Rheumatic Therapies
Patients Enrolled into this study will have received anti-TNF therapy in accordance with NICE
guidelines. Patients may also have received or continue to receive Disease Modifying Anti-
Rheumatic Drugs (DMARD’s). If patients must be stable on 1 or more DMARDS for at least 4
weeks prior to study commencement. Patients may also receive corticosteriod therapy but at a
steady does for at least 4 weeks prior to recruitment.
4.6 Dose modification/reduction/ delay
Adherence to the planned dose regimen of study medication is required unless an adjustment is
necessary for safety reasons. For patients receiving Tocilizumab 8 mg/kg during the period of this
study, the dose may be lowered to 4 mg/kg to manage safety events.
Study: R4RA EudraCT: 2012-002535-28 21 / 34