CompletedNot Applicable

Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)

United States329 participantsStarted 2004-02

Plain-language 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 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Record and analyze birth defects and spontaneous fetal losses

Timeframe: Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy

Record and analyze pregnancy outcomes

Timeframe: 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

Trial details

NCT IDNCT00168714

SponsorBiogen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-09

View on ClinicalTrials.gov More Prenatal Exposure Delayed Effects trials