CompletedPhase 4Relapsing MSNCT03046251

What it found

Results posted, no main test reported

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

GroupValueIntervalNumber analysed
Natalizumab2 Participants4
Control7 Participants24

Natalizumab

2

Control

7

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Natalizumab40 (0.0%)0
Control260 (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 progression
  • Difference 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 progression
  • Change in MRI

    52 weeks

    MRI lesions
  • Percent 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

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    Related trials

    History

      1. Started

        Aug 2015

      2. Main results due

        Dec 2023

      3. Finished

        Dec 2023

      4. Results posted

        Jan 2025

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