CompletedRelapsing MSNCT04655222

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Interferon beta

What it measured

Main measures

  • Percentage of Participants With Live Births Without Congenital Anomalies

    up to end of study (4 months)

  • Percentage of Participants With Live Births With Congenital Anomalies

    up to end of study (4 months)

  • Percentage of Participants With Ectopic Pregnancies

    8 weeks of gestation

  • Percentage of Participants With Spontaneous Abortions

    up to 22 weeks of gestation

  • Percentage of Participants With Elective Abortions

    up to Week 20 of gestation

  • Percentage of Participants With Preterm Births

    up to 37 weeks of gestation

  • Percentage of Participants With Stillbirths

    from 22 week up to 39 weeks of gestation

Other measures (18)

  • Average Weight of the Children

    From Birth up to Month 48

  • Average Length of the Children

    From Birth up to Month 48

  • Average Head Circumference of the Children

    From Birth up to Month 48

  • Percentage of Abnormalities Diagnosed During Pediatric Check-ups

    up to Month 48

  • Percentage of Women Discontinued Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy

    up to 39 weeks of gestation

    Immune response
  • Time to Discontinuation of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Beginning of Pregnancy

    up to 39 weeks of gestation

    Immune response
  • Percentage of Women Starting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy

    up to 39 weeks of gestation

    Immune response
  • Time to Start Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Beginning of Pregnancy

    up to 39 weeks of gestation

    Immune response
  • Percentage of Women Restarting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy After Birth

    up to end of study (4 months)

    Immune response
  • Time to Restart Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Birth

    up to end of study (4 months)

    Immune response

Who could take part

Relapsing MS · 18 and over

Inclusion Criteria: * Diagnosed relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) (CIS indication only applicable for interferon beta-1a) * Exposure to either SC Peginterferon beta-1a therapy or an IM Interferon beta-1a therapy before or during pregnancy * Registered in the PSP of the multiple sclerosis service- center (MSSC) and agreed in writing to the privacy policy of the registration form * Reported pregnancy data (pregnancy report and pregnancy outcome report) available at MSSC. Note: only pregnancy data (i.e. obtained until 15 October 2020) will be considered. * Pregnancy outcome in the retrospectively collected data was a live birth Exclusion Criteria: Any criteria that does not fulfil the above-mentioned inclusion criteria. NOTE: Other protocol defined Inclusion criteria may apply

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

About this trial

In the sponsor's words

The primary objective(s) of the study is to evaluate the impact of exposure to SC Peginterferon beta-1a or IM Interferon beta-1a before and during pregnancy on pregnancy outcome in female participants who had registered in the German Patient Support Program (PSP) and of whom a pregnancy report and pregnancy outcome report is available. The secondary objectives of this study are applicable for a subpopulation of the above-mentioned population, i.e. for participants of whom data on a standardized questionnaire collected during a telephone interview is available.

Papers

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History

    1. Started

      Apr 2021

    2. Main results due

      Oct 2021

    3. Finished

      Oct 2021

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