NAPPREMS
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
Results by group
Relapses Post Partum
52 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Natalizumab | 2 Participants | 4 | |
| Control | 7 Participants | 24 |
Natalizumab
Control
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Natalizumab | 4 | 0 (0.0%) | 0 |
| Control | 26 | 0 (0.0%) | 0 |
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
Relapses Post Partum
52 weeks
Relapses
Other measures (4)
Expanded Disability Status Scale (EDSS) Worsening
52 weeks
Disability progressionDifference in Mean Expanded Disability Status Scale (EDSS) Scores Between Persons With MS (pwMS) Treated With Natalizumab Versus Other Disease-modifying Therapies (DMT)
52 weeks
Disability progressionChange in MRI
52 weeks
MRI lesionsPercent of Relapse Free Patients
52 weeks
Relapses
Who could take part
Relapsing MS · 18 and over
Inclusion Criteria: 1. Female subjects postpartum, 0-30 days postpartum at the time of informed consent. 2. Diagnosis of relapsing form of MS. 3. Willing to initiating natalizumab and enroll in the TOUCH system. 4. Willing and able to comply with the study procedures for the duration of the trial. 5. Signed informed consent and HIPAA authorization. Exclusion Criteria: 1. Diagnosis of primary progressive MS. 2. Breastfeeding 3. Use of IVIG in Tysabri treated subjects. 4. Significant renal or hepatic impairment (in the opinion of the investigator) or other significant disease (e.g., cognitive impairment) that would compromise adherence and completion of the trial. 5. History of hypersensitivity to previous exposure or presence of antibodies to natalizumab. 6. Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation in this study. 7. Patients that experience relapses and/or initiated DMT's during pregnancy The Control group will consist of relapsing MS patients post-delivery who decline natalizumab therapy but open to enroll in the study. Similar Inclusion and Exclusion criteria as the natalizumab group with the exception of requiring TOUCH enrollment program. The Control group will be allowed to initiate any FDA approved DMT at any time post delivery or remain on no therapy while breastfeeding.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to evaluate if monthly natalizumab, initiated after delivery, is effective in preventing postpartum relapses.
Papers
Loading reviews and guidelines…
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History
Started
Aug 2015
Main results due
Dec 2023
Finished
Dec 2023
Results posted
Jan 2025
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