Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy (EARLiMS)
Type of Study/Intervention
Form of MS
Relapsing remitting MS
This is a multi-centre, international trial that will compare the efficacy of fingolimod in two patient populations:
- Untreated relapsing remitting MS patients
- Previously treated relapsing remitting patients with a first line disease modifying therapy, such as interferons or glatiramer acetate.
The main objective of the study is to examine if 0.5mg fingolimod treatment is superior at reducing annual relapse rates in untreated patients, compared to patients that have already received first line therapy. Changes in the time to first relapse, number of lesions and differences between Expanded Disability Status Scale (EDSS) score will also be examined in both patient populations.
For inclusion into this study, a participant must meet the following criteria:
- Aged between 18 and 50 years old, inclusive
- MS diagnosis with a relapse-remitting course AND at least 9 T2 lesions in the brain
- Onset of first symptoms between 1 to 5 years ago (inclusive)
- Prescribed with fingolimod and satisfy the PBS eligibility criteria for fingolimod
- EDSS score between 0 and 3.5
- Either never been treated with a DMT OR received treatment with a first line DMT continuously for at least 1 year.
New South Wales
Liverpool Hospital – Sue Baker, 02 96164687, [email protected]
John Hunter Hospital – Susan Agland, 02 40420331, [email protected]
Brain and Mind Research Institute – Marinda Taha, 02 93510704, [email protected]
Central Coast Neuroscience Research (East Gosford/Kanwal) – Michelle Anderson, 02 43249811, [email protected]
Flinders Medical Centre – Marie Toubia, 08 82044971, [email protected]
Dr Andrew Lee – Suite 3 / 27 College Road, Kent Town SA 5067, 08 8132 0494
Wesley Research Institute – Michelle Cybulski, 07 3721 1527, [email protected]
Royal Brisbane and Women’s Hospital – Genevieve Skinner, 07 36462494, [email protected]
Gold Coast Hospital – Susan Freeman, 07 56780750, [email protected]
Full details of the trial can be found on the clinicaltrials.gov registry.