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 />
Log) of the <strong>study</strong> drug must be ma<strong>in</strong>ta<strong>in</strong>ed. Accountability will be assessed by ma<strong>in</strong>ta<strong>in</strong><strong>in</strong>g<br />
adequate drug dispens<strong>in</strong>g and return records. This will be delegated to the local site pharmacy.<br />
The IMP will be stored by the local pharmacy.<br />
Accurate records must be kept for each <strong>study</strong> drug provided. These records must conta<strong>in</strong> the<br />
follow<strong>in</strong>g:<br />
• Documentation of drug shipments received from the sponsor (date received and<br />
qu<strong>anti</strong>ty)<br />
• Disposition of unused <strong>study</strong> drug not dispensed to patient<br />
When the <strong>study</strong> is completed, the <strong>in</strong>vestigator will return all completed Drug Dispens<strong>in</strong>g<br />
Logs to the trial co-ord<strong>in</strong>ator. Also, any unused <strong>study</strong> drug and Drug Return Records should be<br />
returned to the Monitor. The <strong>in</strong>vestigator's copy of the Drug Return Record(s) must accurately<br />
document the return of all <strong>study</strong> drug supplied.<br />
4.3 Dispens<strong>in</strong>g of IMP<br />
A Drug Dispens<strong>in</strong>g Log will be kept current and will conta<strong>in</strong> the follow<strong>in</strong>g<br />
<strong>in</strong>formation:<br />
• the identification of the patient to whom the <strong>study</strong> medication was dispensed<br />
• the date[s], qu<strong>anti</strong>ty of the <strong>study</strong> medication dispensed to the patient<br />
• the date[s] and qu<strong>anti</strong>ty of the <strong>study</strong> medication returned by the patient.<br />
All records and drug supplies must be available for <strong>in</strong>spection by the Monitor at every<br />
monitor<strong>in</strong>g visit.<br />
When the <strong>study</strong> is completed, the <strong>in</strong>vestigator will return all completed Drug Dispens<strong>in</strong>g<br />
Logs to the monitors.<br />
4.4 IMP Stability<br />
Rituximab<br />
RIituximab solutions for <strong>in</strong>fusion may be stored at 2 -8 o C (36-46 o F) for 24 hours. RIituximab<br />
solutions for <strong>in</strong>fusion have been shown to be stable for an additional 24 hours at room<br />
temperature. However, s<strong>in</strong>ce Rituximab solutions do not conta<strong>in</strong> a preservative, diluted solutions<br />
should be stored refrigerated (2-8 o C) with temperature log. No <strong>in</strong>compatibilities between Rituximab<br />
and polyv<strong>in</strong>ylchloride or polyethylene bags have been observed.<br />
Tocilizumab<br />
All Tocilizumab vials must be stored at a controlled temperature of 2-8°C, and handled accord<strong>in</strong>g<br />
to GMP and GCP procedures. The <strong>in</strong>fusion bag of Tocilizumab <strong>in</strong> sal<strong>in</strong>e may be made up with<strong>in</strong> 24<br />
hours of dos<strong>in</strong>g and must be stored <strong>in</strong> a refrigerator at 2-8°C, provided the site takes precautions to<br />
prepare the <strong>in</strong>fusion aseptically. A temperature log must be kept, on which the storage temperature<br />
of the Tocilizumab and <strong>in</strong>fusion bags is recorded at least once a day.<br />
4.5 Prior and Concomitant Anit-Rheumatic Therapies<br />
Patients Enrolled <strong>in</strong>to this <strong>study</strong> will have received <strong>anti</strong>-TNF therapy <strong>in</strong> accordance with NICE<br />
guidel<strong>in</strong>es. Patients may also have received or cont<strong>in</strong>ue to receive Disease Modify<strong>in</strong>g Anti-<br />
Rheumatic Drugs (DMARD’s). If patients must be stable on 1 or more DMARDS for at least 4<br />
weeks prior to <strong>study</strong> commencement. Patients may also receive corticosteriod therapy but at a<br />
steady does for at least 4 weeks prior to recruitment.<br />
4.6 Dose modification/reduction/ delay<br />
Adherence to the planned dose regimen of <strong>study</strong> medication is required unless an adjustment is<br />
necessary for safety reasons. For patients receiv<strong>in</strong>g Tocilizumab 8 mg/kg dur<strong>in</strong>g the period of this<br />
<strong>study</strong>, the dose may be lowered to 4 mg/kg to manage safety events.<br />
Study: R4RA EudraCT: 2012-002535-28 21 / 34