Treatment Interruption of Natalizumab
Randomized Treatment Interruption of Natalizumab
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
- interferon beta 1-a
- Methylprednisolone
Glucocorticoid receptor agonist
- Glatiramer acetate
Unknown
Compared with
- Glatiramer acetate
Unknown
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Methylprednisolone
Glucocorticoid receptor agonist
Placebo
- IV placebo
Results by group
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.
28 Weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Natalizumab | 4.7 Percentage of subjects meeting criteria | 45 | |
| Intravenous Placebo | 60.5 Percentage of subjects meeting criteria | 41 | |
| Interferon β-1a | 28.6 Percentage of subjects meeting criteria | 14 | |
| Glatiramer Acetate | 53.3 Percentage of subjects meeting criteria | 15 | |
| Methylprednisolone | 54.8 Percentage of subjects meeting criteria | 52 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Intravenous Placebo | 1 | ||
| Natalizumab | 1 | ||
| Interferon β-1a | 1 | ||
| Glatiramer Acetate | 1 | ||
| Methylprednisolone | 1 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
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.
28 Weeks
Disability progressionRelapsesMRI lesionsNatalizumab concentration, immune function, pharmacodynamics, disease activity
Other measures (1)
Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.
28 Weeks
MRI lesions
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
Inclusion criteria
Major criteria include: * A diagnosis of a relapsing form of MS * Treatment with natalizumab according to locally approved prescribing information * Other protocol defined inclusion/exclusion criteria may apply
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Temporal Relationship Between Serum Neurofilament Light Chain and Radiologic Disease Activity in Patients With Multiple Sclerosis.Neurology · 2024
Results
Reversibility of the effects of natalizumab on peripheral immune cell dynamics in MS patients.Neurology · 2017
Results
MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study.Neurology · 2014
Of 167 patients evaluable for efficacy, 49 (29%) had MRI disease activity recurrence: 0/45 (0%) natalizumab, 19/41 (46%) placebo, 1/14 (7%) IM IFN-β-1a, 8/15 (53%) GA, and 21/52 (40%) MP.
Read by software from the paper's abstract
Results
Nakamura K, Brown RA, Narayanan S, Collins DL, Arnold DL; Alzheimer's Disease Neuroimaging Initiative. Diurnal fluctuations in brain volume: Statistical analyses of MRI from large populations. Neuroimage. 2015 Sep;118:126-32. doi: 10.1016/j.neuroimage.2015.05.077. Epub 2015 Jun 3.
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History
Started
Mar 2010
Main results due
Nov 2011
Finished
Nov 2011
Results posted
Jan 2013