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Monoclonal Antibodies

Natalizumab for Multiple Sclerosis (NAPPREMS Trial)

Phase 4
Waitlist Available
Led By Bianca Weinstock-Guttman, MD
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subjects postpartum, 0-30 days postpartum at the time of informed consent
Diagnosis of relapsing form of MS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

NAPPREMS Trial Summary

This trial will test if natalizumab, given monthly after delivery, can prevent postpartum relapses.

Eligible Conditions
  • Multiple Sclerosis

NAPPREMS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Women who have given birth within the last month.
Select...
You have been diagnosed with a type of MS that comes and goes (relapses).

NAPPREMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized Relapse Rate (ARR)
Secondary outcome measures
AUC-EDSS changes
Change in MRI
Confirmed (12 week) EDSS change
+3 more
Other outcome measures
Change in QOL measures

Side effects data

From 2011 Phase 4 trial • 19 Patients • NCT01144052
70%
Infection
10%
gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Natalizumab
Interferon-beta-1b

NAPPREMS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: natalizumabExperimental Treatment1 Intervention
Participants in this group are those who opt to receive treatment with natalizumab IV 300mg/day given q 4 weeks for 48 weeks.
Group II: ControlActive Control1 Intervention
Participants in this group may initiate any FDA approved DMT at any time post delivery or remain on no therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Natalizumab
FDA approved

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
246 Previous Clinical Trials
49,458 Total Patients Enrolled
11 Trials studying Multiple Sclerosis
3,266 Patients Enrolled for Multiple Sclerosis
Bianca Weinstock-Guttman, MD4.616 ReviewsPrincipal Investigator - SUNY Buffalo
State University of New York at Buffalo
3 Previous Clinical Trials
111 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
111 Patients Enrolled for Multiple Sclerosis
5Patient Review
I have been seeing her for over 16 years. She is very knowledgeable and compassionate. She always takes the time to listen to me and explain things in a way that I can understand. I really feel like she cares about me as a person.

Media Library

Natalizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03046251 — Phase 4
Multiple Sclerosis Research Study Groups: natalizumab, Control
Multiple Sclerosis Clinical Trial 2023: Natalizumab Highlights & Side Effects. Trial Name: NCT03046251 — Phase 4
Natalizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03046251 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have been recruited for this research endeavor?

"Unfortunately, recruitment for this trial has ceased since its last edit on August 23rd 2022. However, should you be interested in other research opportunities related to multiple sclerosis, there are currently 549 studies and 7 trials recruiting patients."

Answered by AI

What potential dangers might be associated with this therapeutic treatment?

"The safety of this particular medicine has been established, as it is beneficial in Phase 4 trials. Therefore, our team at Power gave the treatment a score of 3."

Answered by AI

Are there any vacancies in this clinical research for potential participants?

"At present, this medical trial is not enrolling new patients. Initially posted on August 1st 2015 and last updated in the 23rd of August 2022, those looking to participate in a clinical study should look into other trials for multiple sclerosis as there are presently 549 actively recruiting participants along with 7 studies that offer this treatment option."

Answered by AI

What conditions is this treatment regimen typically used to address?

"This treatment may be beneficial for those who are intolerant to conventional therapy, those looking for a standalone solution, and patients with Crohn's disease."

Answered by AI

Is this particular treatment supported by other past clinical investigations?

"Currently, there are seven clinical trials being conducted to assess this treatment. Two of those investigations have reached Phase 3 in their research cycle and the remaining five are based out of Fort Collins, Colorado, with 173 other sites running similar studies."

Answered by AI
~3 spots leftby Apr 2025