Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    State University of New York at Buffalo
Updated on 26 January 2021
natalizumab

Summary

The purpose of this study is to evaluate if monthly natalizumab, initiated after delivery, is effective in preventing postpartum relapses.

Description

Postpartum patients with a diagnosis of multiple sclerosis (MS) will be given the opportunity to enroll in this study that will evaluate the efficacy of IV natalizumab to prevent postpartum relapses. Natalizumab, administered as 300mg IV q 4 weeks, will be initiated postpartum (0-30 days post-delivery).

Patients who decline natalizumab treatment postpartum will be given the opportunity to enroll in the study in the control group. The control group will have similar inclusion and exclusion criteria as well as scheduled visit and study procedures as the active natalizumab treatment group.

The primary objective of the trial is to assess the efficacy of IV administered natalizumab, monthly for 1 year, in preventing relapses during the postpartum period.

The secondary objectives of the trial are to assess the efficacy of natalizumab in decreasing the risk for disability progression during the postpartum period and to prevent the appearance of new and/or enlarging brain MRI lesions as measured by qualitative MRI analysis.

The tertiary objective is to assess the association of the clinical outcomes with subject evaluations including patient reported outcomes.

Details
Condition Multiple Sclerosis, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave, multiple sclerosis (ms)
Treatment natalizumab
Clinical Study IdentifierNCT03046251
SponsorState University of New York at Buffalo
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Radiologically Isolated Syndrome or Multiple Sclerosis or Dermatite Atopique modérée ou grave?
Do you have any of these conditions: Dermatite Atopique modérée ou grave or Radiologically Isolated Syndrome or Multiple Sclerosis or multiple sclerosis (ms)?
Female subjects postpartum, 0-30 days postpartum at the time of informed consent
Diagnosis of relapsing form of MS
Willing to initiating natalizumab and enroll in the TOUCH system
Willing and able to comply with the study procedures for the duration of the trial
Signed informed consent and HIPAA authorization

Exclusion Criteria

Diagnosis of primary progressive MS
Breastfeeding
Use of IVIG in Tysabri treated subjects
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
History of hypersensitivity to previous exposure or presence of antibodies to natalizumab
Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation in this study
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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