Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— NAPPREMS  

Official title:

Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046251
• Other study ID #: US-TYS-14-10720
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: December 2023

Study information

• Verified date: February 2024
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Natalizumab

Locations

Country	Name	City	State
United States	SUNY Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in QOL measures	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.	48 weeks
Primary	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.	48 weeks
Secondary	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	48 weeks
Secondary	AUC-EDSS changes	AUC-EDSS changes from baseline to week 48 between the groups	48 weeks
Secondary	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	48 weeks
Secondary	Time to first relapse	Time to first relapse postpartum will be evaluated and compared between the 2 groups.	48 weeks
Secondary	Percent of relapse free patients	Percent of relapse free patients between the groups	48 weeks
Secondary	Percent of patient that discontinued their DMT	Percent of patient that discontinued their DMT initiated post-partum	48 weeks