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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon Beta Therapy | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | A spontaneous abortion is defined as fetal death before 22 weeks of gestation. | up to 22 weeks of gestation |
| Percentage of Participants With Elective Abortions | up to Week 20 of gestation | |
| Percentage of Participants With Preterm Births | A preterm birth is a birth before 37 completed weeks of gestation. | up to 37 weeks of gestation |
| Percentage of Participants With Stillbirths | A still birth is defined as fetal death at >22 weeks gestation. | from 22 week up to 39 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria: Any criteria that does not fulfil the above-mentioned inclusion criteria.
NOTE: Other protocol defined Inclusion criteria may apply
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All female participants treated with SC Peginterferon beta-1a therapy or IM Interferon beta-1a therapy who fulfil the inclusion criteria are eligible to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Göttingen | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38107443 | Derived | Klehmet J, Begus-Nahrmann Y, Taipale K, Niemczyk G, Rehberg-Weber K. Pregnancy outcomes in female multiple sclerosis patients exposed to intramuscular interferon beta-1a or peginterferon beta-1a reported in a German Patient Support Programme - results from the non-interventional post-authorization safety study PRIMA. Ther Adv Neurol Disord. 2023 Dec 15;16:17562864231214041. doi: 10.1177/17562864231214041. eCollection 2023. | |
| 37393802 |
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In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| 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 |
| 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 |
| Percentage of Women Starting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During 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 Restarting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy After Birth | up to end of study (4 months) |
| Time to Restart Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Birth | up to end of study (4 months) |
| Percentage of Women Starting Another Multiple Sclerosis (MS) Therapy During/After Pregnancy | 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) |
| 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) |
| Change From Baseline Expanded Disability Status Scale (EDSS) During and After Pregnancy to Expanded Disability Status Scale (EDSS) Before Pregnancy | EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in multiple sclerosis (MS). Scores range from 0.0 (normal) to 10.0 (death due to MS). | 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) |
| Duration of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Exposed Breastfeeding | up to end of study (4 months) |
| 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) |
| Derived |
| Klehmet J, Begus-Nahrmann Y, Taipale K, Niemczyk G, Rehberg-Weber K. Impact of interferon beta exposure on birth outcome and child development - Results from the post-authorisation safety study PRIMA. Mult Scler Relat Disord. 2023 Sep;77:104844. doi: 10.1016/j.msard.2023.104844. Epub 2023 Jun 24. |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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