Efficacy and safety of Teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta (TERACLES)

Title
Efficacy and safety of Teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta (TERACLES)

Type of intervention
Drug

Form of MS
Relapsing-remitting

Brief summary
Assess the effect of Teriflunomide in comparison to placebo on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with interferon beta (IFN-β).

Inclusion criteria

• Patient with relapsing forms of multiple sclerosis (MS) treated with Interferon beta (IFN-β) defined by:
• Stable dose of IFN-β for at least 6 months prior to randomization
• Disease activity in the 12 months prior to randomization and after first 3 months of IFN-β treatment (at least one relapse supported by Expanded Disability status Scale (EDSS) or equivalent neurological examination, or, at least one brain or spinal cord Magnetic Resonance Imaging (MRI) with at least one T1 gadolinium enhancing lesion).

Anticipated start date

Recruitment status
Recruiting

Recruitment contacts

• VIC Contacts:
  Austin Health, Melanie McMurtrie/Elise Heriot (03) 9496 3705
  Ballarat Hospital, Carmel Goss (03) 5320 4735

• NSW Contacts:
  RNSH,Cameron Tanner/Jane Kabinoff (02) 9926 7854
  Concord Hospital, Diane Erickson (02) 9767 6819
  Southern Neurology, Lalith Ratnayake 1300 114 439
  Strategic Health, Daria Stepanova (02) 9411 4991
  John Hunter Hospital, Mathew Cox (02) 4985 5883
• SA Contact:
  Flinders Medical Centre, Marie Toubia (08) 8204 4971

Further details
http://clinicaltrials.gov/ct2/show/study/NCT01252355?term=multiple+sclerosis+australia&rank=33&show_locs=Y#locn

Region
NSW, VIC & SA

Trial results

Last updated: January 2012