MSFrontier

LEMTRADA Pregnancy Registry in Multiple Sclerosis

International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
CompletedMS (type not specified)NCT03774914

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

  • Spontaneous abortions (≤20 weeks gestation)

    32 weeks gestation

Other measures (10)

  • Major congenital malformations

    From birth to 1 year after delivery

  • Minor congenital malformations

    From birth to 1 year after delivery

  • Stillbirth (any non-deliberate foetal death at >20 weeks gestation)

    26-32 weeks' gestation to within 6 weeks after the end of the pregnancy

  • Full-term live birth i.e. infants born maturely (≥37 gestation weeks)

    Within 6 weeks after the end of the pregnancy

  • Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term <37 weeks)

    26-32 weeks' gestation to within 6 weeks after the end of the pregnancy

  • Elective terminations i.e. any induced or voluntary fetal loss

    16-20 weeks' gestation

  • Small for gestational age at birth i.e. birth size (weight, length, or head circumference) ≤10th percentile for gender and gestational age

    Within 6 weeks after the end of the pregnancy

  • Any other adverse pregnancy outcomes

    Baseline to week 40

    Safety

  • Infant postnatal growth (up to the first year of life)

    1 year after delivery

  • Infant development impairment (up to the first year of life)

    1 year after delivery

Who could take part

MS (type not specified) · 18 to 55

Inclusion criteria : * Women with Multiple Sclerosis who were or became pregnant within the period of time between the first infusion of a course of treatment with LEMTRADA to 4 months after their last infusion for that course. * Women able and willing to provide informed consent for study participation and the requirement of the study. Informed consent will be obtained at the time of enrollment in accordance with local regulatory requirements. Exclusion criteria: - Previous enrollment in this study for a previous pregnancy. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Primary Objective: The primary goal of this registry is to assess the risk of spontaneous abortion in prospective enrolled women exposed to LEMTRADA for multiple sclerosis. Secondary Objective: The secondary goals of this registry is to assess maternal, fetal and infant outcome in women with multiple sclerosis, exposed to LEMTRADA.

Loading reviews and guidelines…

Related trials

History

    1. Started

      Sept 2015

    2. Main results due

      Nov 2021

    3. Finished

      Nov 2021

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error