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Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis (NAPPREMS)

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ClinicalTrials.gov Identifier: NCT03046251
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Bianca Weinstock-Guttman, State University of New York at Buffalo

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Natalizumab Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
Actual Study Start Date : August 2015
Estimated Primary Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

Arms and Interventions
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Arm Intervention/treatment
natalizumab
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
No Intervention: Control
Participants in this group may initiate any FDA approved DMT at any time post delivery or remain on no therapy.


Outcome Measures
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Primary Outcome Measures :
  1. Annualized Relapse Rate (ARR) [ Time Frame: 48 weeks ]
    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.


Secondary Outcome Measures :
  1. Confirmed (12 week) EDSS change [ Time Frame: 48 weeks ]
    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

  2. AUC-EDSS changes [ Time Frame: 48 weeks ]
    AUC-EDSS changes from baseline to week 48 between the groups

  3. Change in MRI [ Time Frame: 48 weeks ]
    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

  4. Time to first relapse [ Time Frame: 48 weeks ]
    Time to first relapse postpartum will be evaluated and compared between the 2 groups.

  5. Percent of relapse free patients [ Time Frame: 48 weeks ]
    Percent of relapse free patients between the groups

  6. Percent of patient that discontinued their DMT [ Time Frame: 48 weeks ]
    Percent of patient that discontinued their DMT initiated post-partum


Other Outcome Measures:
  1. Change in QOL measures [ Time Frame: 48 weeks ]
    Change in QOL measures that will include: SF12v2, FSMC and MSIS-29 v2 from baseline to week 24 and 48 as compared to the control group.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046251


Contacts
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Contact: Kara Patrick 716-829-5037 kpatrick@buffalo.edu

Locations
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United States, New York
SUNY Buffalo Recruiting
Buffalo, New York, United States, 14203
Contact: Kara Patrick    716-829-5037    kpatrick@buffalo.edu   
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
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Principal Investigator: Bianca Weinstock-Guttman, MD SUNY Buffalo
More Information
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Responsible Party: Bianca Weinstock-Guttman, Professor of Neurology, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT03046251    
Other Study ID Numbers: US-TYS-14-10720
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs