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NCT03046251CompletedPhase 4

Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 24 Jan 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
30 (actual)
First submitted
3 Feb 2017
Start date
1 Aug 2015
Primary completion date
31 Dec 2023
Lead sponsor
State University of New York at Buffalo
NCT number
NCT03046251

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 30
  • From 1 Aug 2015 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of hypersensitivity to previous exposure or presence of antibodies to natalizumab.
  • 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.

Other illness

  • 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.

Other

  • Diagnosis of primary progressive MS.
  • Breastfeeding
  • Use of IVIG in Tysabri treated subjects.
  • Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation in this study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SUNY Buffalo
Coordinator of this site? Confirm its status
BuffaloUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.