Prenatal Exposure Delayed EffectsNCT00168714
Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)
An observational study of Prenatal Exposure Delayed Effects and Multiple Sclerosis, run by Biogen at 1 site in United States.
Trial summary
The primary objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy, where the outcome of the pregnancy was unknown… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Prenatal Exposure Delayed Effects, Multiple Sclerosis, Pregnancy
- What is being tested?
- BG9418 (interferon beta-1a)
- How many people
- 329 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Sep 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women with MS who were exposed to Avonex in the US
Who may be able to join
- Have been exposed to AVONEX within approximately 1 week of conception or during the first trimester of pregnancy.
- Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively).
- Provide verbal consent to participate in the Registry.
- Verbally provide contact information for herself, her HCP, and the infant's HCP (if applicable).
- NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Avonex Pregnancy Exposure Registry
The primary objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy, where the outcome of the pregnancy was unknown prospectively and to prospectively record and analyze pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy, but who may have been exposed to Avonex with approximately 1 week of conception or during the first trimester of pregnancy.
- Being tested
- BG9418 (interferon beta-1a)
- Keywords
- AVONEX, Pregnancy
- Medical subject headings
- Prenatal Exposure Delayed Effects, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG9418 (interferon beta-1a)Drug
Also called Avonex
Exposure to Avonex during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Pregnant participants | Pregnant participants who were exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy Receives: Drug: BG9418 (interferon beta-1a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record and analyze birth defects and spontaneous fetal losses
Measured: Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy
Record and analyze pregnancy outcomes
Measured: Prospectively, MS women who stopped therapy, but may have been exposed to Avonex within 1 week of conception or during the first trimester of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prenatal Exposure Delayed EffectsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 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
- NCT00168714
- Sponsor's protocol ID
- C-871
- Status last verified
- Jun 2014
- First submitted
- 9 Sep 2005
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weinstock-Guttman B, Ross AP, Planton J, White K, Pandhi A, Greco A, Kumar A, Everage N, Vignos M. Analysis of Pregnancy Outcomes Following Exposure to Intramuscular Interferon Beta-1a: The AVONEX(R) Pregnancy Exposure Registry. Drugs Real World Outcomes. 2023 Dec;10(4):503-511. doi: 10.1007/s40801-023-00384-0. Epub 2023 Sep 22.
PubMed 37737962
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avonex Pregnancy Exposure Registry
- ClinicalTrials.gov ID
- NCT00168714
- Acronym / sponsor ID
- C-871
- Keywords
- AVONEX, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Sep 2005 (estimated)
- 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 objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy, where the outcome of the pregnancy was unknown prospectively and to prospectively record and analyze pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy, but who may have been exposed to Avonex with approximately 1 week of conception or during the first trimester of pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant participants | – | Drug: BG9418 (interferon beta-1a)Pregnant participants who were exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with MS who were exposed to Avonex in the US
Key inclusion criteria (5 listed)
- Have been exposed to AVONEX within approximately 1 week of conception or during the first trimester of pregnancy.
- Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively).
- Provide verbal consent to participate in the Registry.
- Verbally provide contact information for herself, her HCP, and the infant's HCP (if applicable).
- NOTE: Other protocol defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| BG9418 (interferon beta-1a)Also: AvonexExposure to Avonex during pregnancy | Drug | Pregnant participants |
Primary outcome
Record and analyze birth defects and spontaneous fetal losses
Time frame: Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy
Record and analyze pregnancy outcomes
Time frame: Prospectively, MS women who stopped therapy, but may have been exposed to Avonex within 1 week of conception or during the first trimester of pregnancy
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 9 Jun 2014.
- Derived from this study: PubMed 37737962Weinstock-Guttman B, Ross AP, Planton J, White K, Pandhi A, Greco A, Kumar A, Everage N, Vignos M. Analysis of Pregnancy Outcomes Following Exposure to Intramuscular Interferon Beta-1a: The AVONEX(R) Pregnancy Exposure Registry. Drugs Real World Outcomes. 2023 Dec;10(4):503-511. doi: 10.1007/s40801-023-00384-0. Epub 2023 Sep 22.
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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 Prenatal Exposure Delayed Effects and Multiple Sclerosis, run by Biogen at 1 site in United States.
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 5 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 9 Jun 2014. 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 United States. 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?
Record and analyze birth defects and spontaneous fetal losses (time frame: Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy). The study lists 2 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 NCT00168714, which also lists 1 linked publication.
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 9 Jun 2014.