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
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
470 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal