Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655222
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2020-11-30
Brief Title:
Study to Investigate Pregnancy Outcomes in Female Participants Exposed to Subcutaneous SC Peginterferon Beta-1a and Intramuscular IM Interferon Beta-1a Reported in a German Participant Support Program
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives 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 ie for participants of whom data on a standardized questionnaire collected during a telephone interview is available
The secondary objectives of this study are applicable for a subpopulation of the above-mentioned population ie for participants of whom data on a standardized questionnaire collected during a telephone interview is available
Detailed Description:
This is an observational study with focus on existing pregnancy reporting forms retrospective part and a patients 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 ie 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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None