Follow up of patients taking part in FTY720D2201
Research type
Research Study
Full title
Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II programme in relapsing multiple sclerosis
IRAS ID
173705
Contact name
Martin Duddy
Contact email
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
This is a UK single-centre follow-up study of patients originally enrolled in the Phase II FTY720D2201 study which was a double-blind placebo-controlled study in patients with relapsing-remitting MS. The original FTY720D2201 site in Newcastle upon Tyne will be required to locate their patients who were randomised in D2201 and ask them if they are willing to return for a Year-10 assessment, regardless of their current treatment status. Patients who participated in the original study and who are currently being followed within the FTY720D2399 protocol will be asked to participate in D2201E2 and will be enrolled concurrently in both studies. The study will consist of up to two visits, up to eight weeks apart:
During Visit 1, patients will be consented to FTY720D2201E2 and the investigations planned for Visit 1 will be performed. These include one MRI scan and the completion of the Mutliple Sclerosis Functional Composite and the Expanded Disability Stauts Scale, both of which will be performed by the Principal Investigator. Patients not under the continuous care of the study site will be asked for permission to obtain external medical records.
• During Visit 2, investigations not completed at Visit 1 will be performed. For
patients not under the continuous care of the study site, historic information will be
reconciled with the obtained external medical records and gaps in historic information will be filled by interviewing these patients.
Both visits may be condensed into one.
Patients will not receive any study treatment; this study does not involve any use of an investigational medicinal product.REC name
HSC REC B
REC reference
15/NI/0122
Date of REC Opinion
21 Jul 2015
REC opinion
Further Information Favourable Opinion