Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

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

Detailed Description
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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.

Official Title
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Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Natalizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: natalizumab<br>Participants in this group are those who opt to receive treatment with natalizumab IV 300mg/day given q 4 weeks for 48 weeks. | Drug: Natalizumab<br> <br> |
| No Intervention: Control<br>Participants in this group may initiate any FDA approved DMT at any time post delivery or remain on no therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Relapse Rate (ARR) | The primary endpoint is the annualized relapse rate (ARR) during 1 year post-delivery in patients treated with natalizumab. This will be compared to the ARR in the parallel control group. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed (12 week) EDSS change | Confirmed (12 week) EDSS change of 1 point or more for a baseline EDSS > 1, or a confirmed increase of 1.5 points for an EDSS of 0-1, at Week 48 as compared to baseline between the 2 groups | 48 weeks | 
| AUC-EDSS changes | AUC-EDSS changes from baseline to week 48 between the groups | 48 weeks | 
| Change in MRI | Change in MRI: MRI at Week 48 for: new or enlarging T2, and T1 gadolinium-enhancing (GdE) lesions counts compared to the change in MRI control group | 48 weeks | 
| Time to first relapse | Time to first relapse postpartum will be evaluated and compared between the 2 groups. | 48 weeks | 
| Percent of relapse free patients | Percent of relapse free patients between the groups | 48 weeks | 
| Percent of patient that discontinued their DMT | Percent of patient that discontinued their DMT initiated post-partum | 48 weeks |