Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

State University of New York at Buffalo30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Interventions

NatalizumabDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

SUNY Buffalo

Buffalo, New York, United States

Outcomes

Primary Outcomes

Relapses Post Partum

The primary endpoint are the relapses during 1 year post-delivery in patients treated with natalizumab. This will be compared to the relapse frequency in the parallel control group.

Time frame: 52 weeks

Secondary Outcomes

Expanded Disability Status Scale (EDSS) Worsening

EDSS scores were determined at multiple timepoints, with scores nearest to week 52 selected for analysis. The difference between EDSS scores at baseline and week 52 were calculated, categorizing patients into two groups: stable or worsened. EDSS worsening was defined as a 1.0 increase for baseline scores below 6.0, or a 0.5-point increase for baseline scores of 6.0 or higher.

Time frame: 52 weeks

Difference in Mean Expanded Disability Status Scale (EDSS) Scores Between Persons With MS (pwMS) Treated With Natalizumab Versus Other Disease-modifying Therapies (DMT)

The Expanded Disability Status Scale (EDSS) is a standardized measure of disability progression in multiple sclerosis (MS), ranging from 0 to 10 in 0.5-unit increments, with higher scores indicating greater disability. EDSS scores were determined at multiple timepoints, with scores nearest to week 52 selected for analysis.

Time frame: 52 weeks

Change in MRI

The patients with MS (pwMS) underwent at least two MRI examinations: the first occurring 1-3 months postpartum (before the first post-partum dose of natalizumab) and a follow-up MRI closest to the week 52 visit. For this study, T2-FLAIR and T1-weighted sequences were acquired before and after gadolinium contrast administration. A licensed and experienced neuroradiologist analyzed the MRI scans, determining the number of new or newly enlarging T2 lesions and new T1 contrast-enhancing (GdE) lesions. The identification of new lesions was based on comparisons with pre-pregnancy scans.

Time frame: 52 weeks

Percent of Relapse Free Patients

Data from ClinicalTrials.gov

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