The DEFINE Trial

The DEFINE trial included patients who were new to relapsing MS treatment and patients who were treatment‐experienced1

Key inclusion criteria2

Experienced at least 1 relapse over the year preceding the trial

OR

Had a brain magnetic resonance imaging (MRI) scan demonstrating at least 1 gadolinium-enhancing (Gd+) lesion within 6 weeks of randomization

AND

An Expanded Disability Status Scale (EDSS) score ranging from 0 to 5

Key exclusion criteria1
  • Interferon-beta or glatiramer acetate within 3 months of randomization
  • An infusion disease-modifying therapy (DMT) or other select therapies* within 6 months of randomization
  • Primary progressive multiple sclerosis, secondary progressive multiple sclerosis, or progressive relapsing multiple sclerosis
  • Any major disease that would preclude participation in a clinical trial

*Please see full Prescribing Information for additional information.

Evaluations2

Neurological evaluations

Performed at baseline, every 3 months, and at time of suspected relapse

MRI evaluations

Performed in 44% of patients at baseline, month 6, and years 1 and 2

69% of patients treated with TECFIDERA BID completed 96 weeks of treatment compared to 65% of patients taking placebo2

The CONFIRM Trial

The CONFIRM trial included patients who were new to relapsing MS treatment and patients who were treatment‐experienced3

Key inclusion criteria2

Experienced at least 1 relapse over the year preceding the trial

OR

Had a brain magnetic resonance imaging (MRI) scan demonstrating at least 1 gadolinium-enhancing (Gd+) lesion within 6 weeks of randomization

AND

An Expanded Disability Status Scale (EDSS) score ranging from 0 to 5

Key exclusion criteria3
  • Interferon-beta or glatiramer acetate within 3 months of randomization
  • An infusion disease-modifying therapy (DMT) or other select therapies* within 6 months of randomization
  • Progressive forms of multiple sclerosis
  • Any major disease that would preclude participation in a clinical trial

*Please see full Prescribing Information for additional information.

Evaluations2

Neurological evaluations

Performed at baseline, every 3 months, and at time of suspected relapse

MRI evaluations

Performed in 48% of patients at baseline, month 6, and years 1 and 2

70% of patients treated with TECFIDERA BID completed 96 weeks of treatment compared to 64% of patients taking placebo2

*Study also randomized patients (n=416) to a 240 mg TID arm. TID dosing resulted in no additional benefit over 240 mg BID.2
Study also randomized patients (n=345) to a 240 mg TID arm. TID dosing resulted in no additional benefit over 240 mg BID.2
Disease activity: any change in relapse frequency, MRI activity, and/or disability progression.