Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis (NAPPREMS)
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
|Official Title:||Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis|
- 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.
- 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
- AUC-EDSS changes [ Time Frame: 48 weeks ]AUC-EDSS changes from baseline to week 48 between the groups
- 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
- Time to first relapse [ Time Frame: 48 weeks ]Time to first relapse postpartum will be evaluated and compared between the 2 groups.
- Percent of relapse free patients [ Time Frame: 48 weeks ]Percent of relapse free patients between the groups
- Percent of patient that discontinued their DMT [ Time Frame: 48 weeks ]Percent of patient that discontinued their DMT initiated post-partum
- 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.
|Actual Study Start Date:||August 2015|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Participants in this group are those who opt to receive treatment with natalizumab IV 300mg/day given q 4 weeks for 48 weeks.
No Intervention: Control
Participants in this group may initiate any FDA approved DMT at any time post delivery or remain on no therapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03046251
|Contact: Kara Patrickfirstname.lastname@example.org|
|United States, New York|
|Buffalo, New York, United States, 14203|
|Contact: Kara Patrick 716-859-7510 email@example.com|
|Principal Investigator:||Bianca Weinstock-Guttman, MD||SUNY Buffalo|