This document outlines the consent form for patients receiving Cladribine treatment for multiple sclerosis (MS) at Barts Health NHS Trust hospitals. It details 5 points that patients must initial to confirm their understanding of and agreement to the risks and monitoring involved with Cladribine treatment. These include being informed of the risk-benefit profile of Cladribine based on clinical trials, understanding it is not a licensed treatment for MS, discussing alternative treatments, agreeing to adhere to safety monitoring protocols, and using contraception during treatment and for 6 months after.

1. Barts Health NHS Trust: Newham University Hospital, The London Chest Hospital,
The Royal London Hospital, St Bartholomew’s Hospital and Whipps Cross Hospital.
BartsMS Consent Sheet Cladribine, drafted by Drs Monica Marta & Niall MacDougall, reviewed & edited by Dr Klaus Schmierer
5 November 2015. Scheduled review October 2016
17th
September 2015
Name:
Hospital no:
NHS no:
Date of Birth:
Cladribine for treatment of people with multiple sclerosis
Consent
Please initial as appropriate
Patient Witness Not
applicable
1.
I have read the BartsMS Patient Information Sheet “Cladribine for
treatment of people with multiple sclerosis” and have been
comprehensively informed about the risk benefit profile of
Cladribine on the basis of clinical trial evidence and the
management of potential adverse effects such as allergic reactions,
injection site reactions and infections.
2.
I am aware Cladribine is not licensed for MS, and that I receive this
treatment at the discretion of the BartsMS team on a
compassionate and voluntary basis.
3.
Currently licensed treatment alternatives for my MS have been
discussed with me. However, on the balance of their risk-benefit
profile in my individual case I refuse these alternatives in favour of
the treatment with Cladribine.
4.
I agree to adhere to the monitoring protocol to ensure the safety of
my treatment with Cladribine, including review of vital signs, blood
tests, urinalysis, etc. I am aware I need to undergo regular blood
tests and I have to notify my clinical team (neurologist, MS
Specialist Nurse, GP, other health care professional involved in my
care) of any infection to decide whether immediate treatment is
required, and of any other unexpected event.
5.
Women who may become pregnant and men who may father a
child must use safe contraception whilst on treatment with
Cladribine, and for 6 months after the last dose of Cladribine was
administered. I hereby confirm I will use appropriate contraception
measures during the treatment period and for 6 months after
receiving my last dose of Cladribine.
________________________ ________________ ____________________
Name of Patient Date Signature
_________________________ ________________ ____________________
Name of person taking consent Date Signature
Neurology Infusion and Planned Investigation Unit
Department of Neurology
The Royal London Hospital
Ward 11D, 11th
Floor, Central Tower
Whitechapel, London, E1 1BB
Switchboard: 020 3594 0000
Direct Dial Ward Number: 0203 5940637/0638
Ward Manager: Maria Espasandin
www.bartshealth.nhs.uk