Back to resultsNatalizumab in Preventing Post-partum Relapses in Multiple Sclerosis (NAPPREMS)
Primary Purpose
Multiple Sclerosis
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Natalizumab
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis
Eligibility Criteria
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.
Sites / Locations
- SUNY Buffalo
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
natalizumab
Control
Arm Description
Participants in this group are those who opt to receive treatment with natalizumab IV 300mg/day given q 4 weeks for 48 weeks.
Participants in this group may initiate any FDA approved DMT at any time post delivery or remain on no therapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
AUC-EDSS changes
AUC-EDSS changes from baseline to week 48 between the groups
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
Time to first relapse
Time to first relapse postpartum will be evaluated and compared between the 2 groups.
Percent of relapse free patients
Percent of relapse free patients between the groups
Percent of patient that discontinued their DMT
Percent of patient that discontinued their DMT initiated post-partum
Full Information
NCT ID
NCT03046251
First Posted
February 3, 2017
Last Updated
August 23, 2022
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT03046251
Brief Title
Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
Acronym
NAPPREMS
Official Title
Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
natalizumab
Arm Type
Other
Arm Description
Participants in this group are those who opt to receive treatment with natalizumab IV 300mg/day given q 4 weeks for 48 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group may initiate any FDA approved DMT at any time post delivery or remain on no therapy.
Intervention Type
Drug
Intervention Name(s)
Natalizumab
Primary Outcome Measure Information:
Title
Annualized Relapse Rate (ARR)
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Confirmed (12 week) EDSS change
Description
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
Time Frame
48 weeks
Title
AUC-EDSS changes
Description
AUC-EDSS changes from baseline to week 48 between the groups
Time Frame
48 weeks
Title
Change in MRI
Description
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
Time Frame
48 weeks
Title
Time to first relapse
Description
Time to first relapse postpartum will be evaluated and compared between the 2 groups.
Time Frame
48 weeks
Title
Percent of relapse free patients
Description
Percent of relapse free patients between the groups
Time Frame
48 weeks
Title
Percent of patient that discontinued their DMT
Description
Percent of patient that discontinued their DMT initiated post-partum
Time Frame
48 weeks
Other Pre-specified Outcome Measures:
Title
Change in QOL measures
Description
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.
Time Frame
48 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bianca Weinstock-Guttman, MD
Organizational Affiliation
SUNY Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
We'll reach out to this number within 24 hrs