NaTDS
What it found
We found no results in the registry or in papers.
This trial finished 12 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Natalizumab discontinuation
What it measured
Main measures
Number of recorded infections including viral opportunistic infection
Up to 1 year follow-up
Saturation percentage of α4β1integrin receptors on the surface of lymphocytes
12 months
Immune responseNumber gadolinium-enhancing lesions
Change between baseline-6 months, 6 months-12 months, and baseline-12 months
MRI lesionsAbsolute changes in gadolinium-enhancing and T2-weighted lesion volume between timepoints
Change between baseline-6 months, 6 months-12 months, and baseline-12 months
MRI lesionsSum of new and enlarging T2-weighted lesions
Change between baseline-6 months, 6 months-12 months, and baseline-12 months
MRI lesions
Other measures (2)
Number of clinical relapses
Either baseline (immediate discontinuation group) or 6 months (taper-off group)
RelapsesExpanded Disability Status Scale (EDSS) score
Either baseline (immediate discontinuation group) or 6 months (taper-off group)
Disability progression
Who could take part
Relapsing and progressive · 18 to 65
Inclusion Criteria: * Patient with relapsing-remitting or relapsing-progressive (relapsing-remitting with incomplete recovery and secondary progressive with superimposed relapses) MS according to the McDonald criteria who have been on natalizumab therapy for at least 12 months * Age 18-65 * Have EDSS scores less than or equal to 7.0 * Positive John Cunningham (JC) virus antibody results at screening * Signed informed consent * None of the exclusion criteria Exclusion Criteria: * Patients not willing or able to personally provide informed consent (subjects with cognitive impairment that effects the ability to provide informed consent for participation) * Patients with active disease per clinical and MRI evaluation at baseline * Patients with renal disease that precludes having an MRI with gadolinium contrast
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study evaluates the discontinuation of natalizumab either immediately or tapered off in the treatment of multiple sclerosis. Half of the fifty (50) participants will discontinue natalizumab immediately and the other half will taper off the drug, having two additional infusions, one at six weeks- and one at eight weeks-post discontinuation.
Papers
Loading reviews and guidelines…
Related trials
- ASCEND in SPMS
Phase 3 · Stopped early
Stopped: not working
- Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
Phase 1 · Completed
Result in a paper, not read yet
History
Started
Nov 2012
Main results due
Mar 2014
Finished
Mar 2014
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