Non-interventional Safety Study to Investigate Pregnancy Outcomes in Female Patients Exposed to SC Peginterferon Beta-1a and IM Interferon Beta-1a Reported in a German Patient Support Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Ectopic Pregnancies
研究概览
简要总结
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.
详细描述
This is an observational study with focus on existing pregnancy reporting forms (retrospective part) and a patient's questionnaire which is completed at a single point of time (prospective part). Main data source for the retrospective data (from 2014 until December 2019) will be captured from multiple sclerosis service-center (MSSC) database, i.e. the entered pregnancy report (to be completed as soon as pregnancy becomes known) and pregnancy outcomes report (to be completed after completion of pregnancy).
Prospective data (December 2020 to 31 March 2021) will be captured as standardized ePDF questionnaire completed during telephone interview. If the pregnancy report or the pregnancy outcome report is incomplete, i.e. the data above was not collected, the open questions will be addressed during a telephone interview performed by the MSSC and the new information will be entered into the MSCC database. The patient questionnaire will be completed at a single point of time during the telephone interview performed by the MSSC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Any criteria that does not fulfil the above-mentioned inclusion criteria.
- •NOTE: Other protocol defined Inclusion criteria may apply
研究组 & 干预措施
All Participants
Pregnant Multiple Sclerosis (MS) participants treated with SC interferon beta therapy or an IM interferon beta therapy in the German PSP of the MSSC.
干预措施: Interferon Beta Therapy (Drug)
结局指标
主要结局
Percentage of Participants With Ectopic Pregnancies
时间窗: 8 weeks of gestation
Percentage of Participants With Stillbirths
时间窗: from 22 week up to 39 weeks of gestation
A still birth is defined as fetal death at \>22 weeks gestation.
Percentage of Participants With Live Births Without Congenital Anomalies
时间窗: up to end of study (4 months)
Percentage of Participants With Elective Abortions
时间窗: up to Week 20 of gestation
Percentage of Participants With Live Births With Congenital Anomalies
时间窗: up to end of study (4 months)
Percentage of Participants With Spontaneous Abortions
时间窗: up to 22 weeks of gestation
A spontaneous abortion is defined as fetal death before 22 weeks of gestation.
Percentage of Participants With Preterm Births
时间窗: up to 37 weeks of gestation
A preterm birth is a birth before 37 completed weeks of gestation.
次要结局
- Average Head Circumference of the Children(From Birth up to Month 48)
- Percentage of Abnormalities Diagnosed During Pediatric Check-ups(up to Month 48)
- Time to First Multiple Sclerosis (MS) Relapse After Introduction of the First Supplemental Feedings in Women With Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Lactation(up to end of study (4 months))
- Percentage of Women Restarting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy After Birth(up to end of study (4 months))
- Duration of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Exposed Breastfeeding(up to end of study (4 months))
- Percentage of Women Discontinued Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy(up to 39 weeks of gestation)
- Average Length of the Children(From Birth up to Month 48)
- Percentage of Women Starting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy(up to 39 weeks of gestation)
- Time to Restart Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Birth(up to end of study (4 months))
- Time to Start Another MS Therapy During/After Pregnancy in Relation to Birth(up to end of study (4 months))
- Change From Baseline Expanded Disability Status Scale (EDSS) During and After Pregnancy to Expanded Disability Status Scale (EDSS) Before Pregnancy(Week 0 up to Week 39 of gestation)
- Number of Women Breastfeeding Under Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy(up to end of study (4 months))
- Average Weight of the Children(From Birth up to Month 48)
- 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)
- 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)
- Percentage of Women Starting Another Multiple Sclerosis (MS) Therapy During/After Pregnancy(up to end of study (4 months))
- Percentage of Women Using Other Therapies During Pregnancy(up to 39 weeks of gestation)
- Percentage of Multiple Sclerosis Relapses in Women with Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Before, During and After Pregnancy(up to end of study (4 months))