The TOPIC study - Multiple Sclerosis Society

The TOPIC study
A trial comparing teriflunomide to a placebo in people newly diagnosed
with multiple sclerosis
Multiple sclerosis (MS) is caused by the immune system attacking the
brain and spinal cord. Teriflunomide is a drug that may decrease the level
of this attack in people with MS. Results of a previous trial in 179 people
with MS showed that teriflunomide reduced the number of brain lesions
detected by MRI. Teriflunomide is similar to the drug leflunomide, also
known as Arava®, which is already approved in many countries for the
treatment of rheumatoid arthritis.
This trial aims to test the safety and effectiveness of teriflunomide to see
whether early treatment can reduce the severity of symptoms associated
with MS.
Phase
Phase III
Recruitment
Start: February 2008
End: April 2011
Who can enter the trial
You can take part in this trial if:
• You have had a first acute or subacute, well-defined neurological event
consistent with demyelination (i.e.optic neuritis confirmed by an
ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes)
• You have had an onset of MS symptoms occurring within 60 days after
being allocated at random to the treatment groups in the trial
(randomisation)
• You have a MRI scan showing two or more T2 lesions at least 3mm in
diameter that are characteristic of MS.
Exclusion Criteria
You cannot take part in this study if:
• You have a clinically relevant cardiovascular, hepatic, neurological,
endocrine or other major systemic disease
• You have significantly impaired bone marrow function
• You are pregnant or nursing
• You have a history of alcohol or drug abuse
• You have been treated with any of the following medications or
procedures prior to taking part in the study:
Cladribine, mitoxantrone, or other immunosuppressant agents such as
azathioprine, cyclophosphamide, cyclosporin, methotrexate or
mycophenolate
• There are any other reasons that, in the opinion of the Investigator and/or
the Sponsor, you are determined to be unsuitable for enrolment in this
study
• Other criteria apply which your doctor will discuss with you. Trial design
This is a randomised, parallel-group, double blind, parallel arm trial
comparing two doses (7mg or 14mg) of teriflunomide with a placebo.
People in both the placebo and treatment groups of the trial will take 1
tablet a day in the morning. The study aims to enroll 780 people with MS.
How many times (and how often) they have treatment
This study consists of three stages:
1. The screening phase: This phase will take up to four weeks
2. The treatment phase: Both the treatment and placebo groups will take
one tablet a day for 108 weeks
3. The post-treatment phase: After people have completed their
treatments and are no longer receiving any medication, two follow visits
will be required, the first at four weeks and the second at 16 weeks
(Washout procedure).
There may also be the option to take part in an extension study where
participants will have the choice to continue taking the drug after the trial
has ended. Participants in the extension study will not be required to
undergo stage three above.
Side effects
More side effects were reported for the higher dose taken in previous
trials. Known side effects include nausea, headaches, diarrhoea, and limb
pain.
UK locations of the trial
• The Royal London Hospital, Department of Neurology
City: London
Investigator: Dr. Ben Turner
Phone: 0207 377 7000
Email: [email protected]
Study Co-ordinator: Krzysztof Rutkowski
Email: [email protected]
• The Royal Hallamshire Hospital, Department of Neurology
City: Sheffield
Investigator: Dr. Sian Price
Phone: 0114 2711977
Email: [email protected]
• University Hospital of North Staffordshire, Department of Neurology
City: Stoke on Trent
Investigator: Prof. Clive Hawkins
Phone: 01782 555008
Email: [email protected].uk
Study Co-ordinator: Sharon Hurlstone
Phone: 01782 555008
• St. George's Hospital, Department of Neurology
City: London
Investigator: Dr. David Barnes
Phone: 0208 725 4631
Email: [email protected]
Study Co-ordinator: Christine Gregory
Phone: 02087254162
• Queens Medical Centre, Division of Clinical Neurology
City: Nottingham
Investigator: Dr. Nikos Evangelou
Phone: 0115 849 3285
Email: [email protected]
Study Co-ordinator: Kathryn Hewitt
Phone: 01158493285
Email: [email protected]
• Greater Manchester Neurosciences Centre
City: Manchester
Investigator: Dr. David Rog
Phone: 0161 206 0534
Email: [email protected]
Study Co-ordinator: Stephanie Mitchell
Phone: 0161 206 0534
Contact details
If you are interested in taking part please discuss this information with
your neurologist or GP.