Clinical trial NCT03046251: Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
Official title: Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relapses Post Partum
timeFrame: 52 weeks
Secondary outcomes:
measure: Expanded Disability Status Scale (EDSS) Worsening
timeFrame: 52 weeks
measure: Difference in Mean Expanded Disability Status Scale (EDSS) Scores Between Persons With MS (pwMS) Treated With Natalizumab Versus Other Disease-modifying Therapies (DMT)
timeFrame: 52 weeks
measure: Change in MRI
timeFrame: 52 weeks
measure: Percent of Relapse Free Patients
timeFrame: 52 weeks
Other outcomes:
measure: Change in QoL Measures
timeFrame: 52 weeks
measure: Proportion of Postpartum MS Patients With Disability Progression Comparing Those Who Used a Disease Modifying Therapy (DMT) After Delivery vs Those Who Did Not Re-start a DMT After Delivery.
timeFrame: 52 weeks
measure: Difference in EDSS Scores Between Patients With MS (pwMS) Who Used a Disease Modifying Therapy (DMT) After Delivery vs Those Who Did Not Re-start a DMT After Delivery.
timeFrame: 52 weeks
Locations:
city: Buffalo
country: United States
facility: SUNY Buffalo
state: New York
Study officials:
affiliation: SUNY Buffalo
name: Bianca Weinstock-Guttman, MD
role: PRINCIPAL_INVESTIGATOR
References: