Multiple SclerosisNCT04655222
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
An observational study of Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Interferon Beta Therapy
- How many people
- 470 participants
- Where
- 1 siteGermany
- Study dates
- 30 Apr 2021to 15 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Being tested
- Interferon Beta Therapy
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Beta TherapyDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Interferon Beta Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Live Births Without Congenital Anomalies
Measured: up to end of study (4 months)
Percentage of Participants With Live Births With Congenital Anomalies
Measured: up to end of study (4 months)
Percentage of Participants With Ectopic Pregnancies
Measured: 8 weeks of gestation
Percentage of Participants With Spontaneous Abortions
A spontaneous abortion is defined as fetal death before 22 weeks of gestation.
Measured: up to 22 weeks of gestation
Percentage of Participants With Elective Abortions
Measured: up to Week 20 of gestation
Percentage of Participants With Preterm Births
A preterm birth is a birth before 37 completed weeks of gestation.
Measured: up to 37 weeks of gestation
Percentage of Participants With Stillbirths
A still birth is defined as fetal death at >22 weeks gestation.
Measured: from 22 week up to 39 weeks of gestation
Secondary outcomes (18)
Average Weight of the Children
Measured: From Birth up to Month 48
Average Length of the Children
Measured: From Birth up to Month 48
Average Head Circumference of the Children
Measured: From Birth up to Month 48
Percentage of Abnormalities Diagnosed During Pediatric Check-ups
Measured: up to Month 48
Percentage of Women Discontinued Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy
Measured: 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
Measured: up to 39 weeks of gestation
Percentage of Women Starting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy
Measured: 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
Measured: up to 39 weeks of gestation
Percentage of Women Restarting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy After Birth
Measured: up to end of study (4 months)
Time to Restart Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Birth
Measured: up to end of study (4 months)
Percentage of Women Starting Another Multiple Sclerosis (MS) Therapy During/After Pregnancy
Measured: up to end of study (4 months)
Time to Start Another MS Therapy During/After Pregnancy in Relation to Birth
Measured: up to end of study (4 months)
Percentage of Women Using Other Therapies During Pregnancy
Measured: 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
Measured: 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).
Measured: Week 0 up to Week 39 of gestation
Number of Women Breastfeeding Under Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy
Measured: up to end of study (4 months)
Duration of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Exposed Breastfeeding
Measured: 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
Measured: up to end of study (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start30 Apr 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655222
- Sponsor's protocol ID
- DE-PEG-11650
- Status last verified
- Apr 2023
- First submitted
- 30 Nov 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Publications
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.
PubMed 38107443Klehmet 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.
PubMed 37393802
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04655222
- Acronym / sponsor ID
- DE-PEG-11650
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Drug: Interferon Beta TherapyPregnant Multiple Sclerosis (MS) participants treated with SC interferon beta therapy or an IM interferon beta therapy in the German PSP of the MSSC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon Beta TherapyAdministered as specified in the treatment arm. | Drug | All Participants |
Primary outcome
Percentage of Participants With Live Births Without Congenital Anomalies
Time frame: up to end of study (4 months)
Percentage of Participants With Live Births With Congenital Anomalies
Time frame: up to end of study (4 months)
Percentage of Participants With Ectopic Pregnancies
Time frame: 8 weeks of gestation
Percentage of Participants With Spontaneous Abortions
Time frame: up to 22 weeks of gestation
A spontaneous abortion is defined as fetal death before 22 weeks of gestation.
Percentage of Participants With Elective Abortions
Time frame: up to Week 20 of gestation
Percentage of Participants With Preterm Births
Time frame: up to 37 weeks of gestation
A preterm birth is a birth before 37 completed weeks of gestation.
Percentage of Participants With Stillbirths
Time frame: from 22 week up to 39 weeks of gestation
A still birth is defined as fetal death at >22 weeks gestation.
18 secondary outcomes
Average Weight of the Children
Time frame: From Birth up to Month 48
Average Length of the Children
Time frame: From Birth up to Month 48
Average Head Circumference of the Children
Time frame: From Birth up to Month 48
Percentage of Abnormalities Diagnosed During Pediatric Check-ups
Time frame: up to Month 48
Percentage of Women Discontinued Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy
Time frame: 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
Time frame: up to 39 weeks of gestation
Percentage of Women Starting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy During Pregnancy
Time frame: 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
Time frame: up to 39 weeks of gestation
Percentage of Women Restarting Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy After Birth
Time frame: up to end of study (4 months)
Time to Restart Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy in Relation to Birth
Time frame: up to end of study (4 months)
Percentage of Women Starting Another Multiple Sclerosis (MS) Therapy During/After Pregnancy
Time frame: up to end of study (4 months)
Time to Start Another MS Therapy During/After Pregnancy in Relation to Birth
Time frame: up to end of study (4 months)
Percentage of Women Using Other Therapies During Pregnancy
Time frame: 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
Time frame: 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
Time frame: Week 0 up to Week 39 of gestation
Number of Women Breastfeeding Under Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy
Time frame: up to end of study (4 months)
Duration of Subcutaneous Peginterferon Beta-1a or Intramuscular Interferon Beta-1a Therapy Exposed Breastfeeding
Time frame: 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
Time frame: up to end of study (4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 38107443Klehmet 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.
- Derived from this study: PubMed 37393802Klehmet 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.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Live Births Without Congenital Anomalies (time frame: up to end of study (4 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04655222, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.