This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab. The main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks: * when MS symptoms return, and * if other drugs for MS may help control MS symptoms during the natalizumab-interruption period. This study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
175
300 mg intravenous every 4 weeks
30 ug intramuscular once per week
1000 mg intravenous every 4 weeks
Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria.
Rescue criteria were: 1) central reader MRI finding of 1 new gadolinium-enhancing (Gd+) lesion of \>0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size 2) clinical relapse. Clinical relapse was new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, as defined by: an increase of ≥1 grade in ≥2 functional scales of the Expanded Disability Status Scale (EDSS); an increase of ≥2 grades in 1 functional scale of the EDSS; or an increase of \>0.5 in EDSS if the previous EDSS was ≤5.5, or ≥0.5 if the previous EDSS was \>5.5
Time frame: 28 Weeks
Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.
MRI rescue criteria were the presence of 1 new gadolinium-enhancing (Gd+) lesion of \>0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size, according to the central MRI reader.
Time frame: 28 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
placebo intravenous every 4 weeks
20 mg subcutaneous once daily
Research Site
Cullman, Alabama, United States
Research Site
San Francisco, California, United States
Research Site
Fort Collins, Colorado, United States
Research Site
Pompano Beach, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Lake Barrington, Illinois, United States
Research Site
Des Moines, Iowa, United States
Research Site
Boston, Massachusetts, United States
...and 23 more locations