Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

NCT03046251 | Completed Phase 4 Results FDA Drug

• 1 other identifier: US-TYS-14-10720
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Relapses Post Partum

  The primary endpoint are the relapses during 1 year post-delivery in patients treated with natalizumab. This will be compared to the relapse frequency in the parallel control group.

  52 weeks

Secondary Outcomes (4)

• Expanded Disability Status Scale (EDSS) Worsening

  52 weeks

• Difference in Mean Expanded Disability Status Scale (EDSS) Scores Between Persons With MS (pwMS) Treated With Natalizumab Versus Other Disease-modifying Therapies (DMT)

  52 weeks

• Change in MRI

  52 weeks

• Percent of Relapse Free Patients

  52 weeks

Other Outcomes (3)

• Change in QoL Measures

  52 weeks

• 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.

  52 weeks

• 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.

  52 weeks

Study Arms (2)

natalizumab

OTHER

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

Control

NO INTERVENTION

Participants in this group may initiate any FDA approved DMT at any time post delivery or remain on no therapy.

Interventions

Natalizumab DRUG

natalizumab

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

SUNY Buffalo

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The study's nature required long waiting periods for pregnancies, and not all pregnant pwMS were open to enrollment. The demands of early motherhood led to significant drop-out rates over the four follow-up visits. Many patients opted out of starting natalizumab post-delivery as initially intended. These factors, combined with the COVID-19 pandemic, which significantly impacted research participation, resulted in a small sample size and diminishing cases throughout the follow-up period.

Results Point of Contact

• Title: Dr. Bianca Weinstock-Guttman
• Organization: Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, NY, USA.

bw8@buffalo.edu

716-829-4415

Study Officials

• Bianca Weinstock-Guttman, MD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 8, 2017
• Study Start: August 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 24, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)