Natalizumab in Breakthrough Disease: ESCALATE

A Phase 4 Multicenter Open-Label, Single Arm Study to Evaluate Switching from BRACET/Gilenya® to Natalizumab in Subjects with Relapsing Forms of Multiple Sclerosis (ESCALATE, 101MS409)

Description:

Natalizumab (Tysabri™) was approved as an effective therapy for MS in 2004. Natalizumab is administered as an infusion every 4 weeks, and works by reducing the number of inflammatory cells that get into the brain.

The rationale of this study is to determine whether natalizumab is associated with no further disease activity over 2 years (i.e. relapses, new MRI lesions, disability progression) in patients who are having breakthough disease on one of the other available MS treatments. Everyone who participants will receive natalizumab.

The study will include 24 months of treatment, with treatment infusions every 4 weeks and 13 study visits.

People eligible for participation include:

  1. Age 18 – 60.
  2. Diagnosis of Relapsing Multiple Sclerosis.
  3. Treated for at least 12 months with Gilenya®, Betaseron®, Rebif®, Avonex®, Copaxone®, Extavia®, Tecfidera®.
  4. Any MS disease activity in the prior6 months. Disease activity may include a relapse, new MRI lesion, or worsening disability.
  5. Baseline EDSS 0 – 5.5 (No disability through ambulates 200 meters independently).
  6. For female participants, no desire for pregnancy during the study.
  7. Any prior treatment with natalizumab must be over 1 year ago, and discontinuation must not be due to intolerance and ineffectiveness.

Length of Trial:

The trial will be 25 months, including 4-6 weeks for screening and 24 months of treatment. There are 13 total visits over the 25 months.


Clinical Trial Sponsor:

Biogen Idec.

Who is the Principal Investigator (Doctor):

Robert T. Naismith, MD

Neurology, Campus Box 8111

660 South Euclid Ave.

St. Louis, MO 63110

Contact:

Susan Fox, Research Patient Coordinator

314-362-2017

Neurology, Campus Box 8111

660 South Euclid Ave.

St. Louis, MO 63110