PregnancyNCT00342862
AMEVIVE® Pregnancy Registry
An observational study of Pregnancy, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
This is an observational, exposure-registration and follow-up study, to be conducted in the United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the risk of major birth defects. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Amevive exposure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Dec 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 psoriasis exposed to AMEVIVE® at any point within 8 weeks prior to conception, or at any time during pregnancy, where the outcome of the pregnancy is unknown prospectively
Who may be able to join
- Have been exposed to AMEVIVE® within 8 weeks prior to conception or at any time during 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, and
- Verbally provide the contact information for herself, her healthcare provider (HCP), and the infant's HCP (if applicable)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment and Tracking of Long-Term Alefacept (LFA-3/IgG1 Fusion Protein) Pregnancy Exposure Registry
This is an observational, exposure-registration and follow-up study, to be conducted in the United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the risk of major birth defects.
The AMEVIVE® Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development and will be managed by INC Research. The Registry will be monitored by an independent Advisory Committee of external experts in relevant specialties of teratology, epidemiology, maternal and fetal medicine, and infectious disease medicine (external member details available upon request).
Read the detailed description
Prospective reports will be collected from pregnant subjects, health care provider (HCP), or Astellas Product Safety Management staff. Data from the pregnant subjects will be collected at 4 to 5 months of pregnancy by telephone interviews with the Registry. The Registry will also contact the subject at 2 months and 12 months after the estimated delivery date (EDD) for post-natal \& pediatric follow-up. The Registry will confirm the information collected from the subject with the HCP by telephone interviews with the Registry, forms mailed/faxed to the Registry, electronic forms/queries sent to the Registry, or a combination of these methods. If a live birth is reported, the infant's HCP will be contacted for the Pediatric Follow-Up at 2 months and 12 months of age. If a birth defect is reported, targeted follow-up will be conducted.
- Conditions
- Pregnancy
- Being tested
- Amevive exposure
- Keywords
- Pregnancy, Amevive, alefacept, Registry, Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amevive exposureDrug
Also called alefacept, ASP0485
Observational
| Study group | Role | What they receive |
|---|---|---|
| 1. Amevive Exposure | Pregnant women with psoriasis exposed to AMEVIVE® at any point within 8 weeks prior to conception, or at any time during pregnancy, where the outcome of the pregnancy is unknown prospectively Receives: Drug: Amevive exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate pattern or increase in major birth defects in children of women w/ psoriasis who were exposed to AMEVIVE® at any time within the 8 wks prior to conception, or at any time during pregnancy, where outcome of the pregnancy is unknown prospectively
Measured: At month 4 to 5 of pregnancy; At 2 months and 12 months post estimated delivery date
Secondary outcomes (6)
To evaluate the number of live born infants versus fetal loss in pregnant women exposed to AMEVIVE®
Measured: At 2 months post estimated delivery date
To evaluate gestational age, body weight, gender, head circumference, and body length in live born infants exposed to AMEVIVE®
Measured: At 2 months post estimated delivery date
To evaluate appearance, pulse, grimace, activity, and respiration (APGAR) scores at 1 and 5 minutes of age in live born infants exposed to AMEVIVE®
Measured: At 2 months post estimated delivery date
To evaluate hospitalizations for infection in live born infants exposed to AMEVIVE®
Measured: At 2 months and 12 months post estimated delivery date
To evaluate clinically significant infections with unusual organisms, not requiring hospitalization in live born infants exposed to AMEVIVE®
Measured: At 2 months and 12 months post estimated delivery date
To evaluate malignancies in live born infants exposed to AMEVIVE®
Measured: At 2 months and 12 months post estimated delivery date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study startDec 2003
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vice President Medical Affairs, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342862
- Sponsor's protocol ID
- 0485-CL-0002
- Other IDs
- C-739
- Status last verified
- Dec 2013
- First submitted
- 19 Jun 2006
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Tracking of Long-Term Alefacept (LFA-3/IgG1 Fusion Protein) Pregnancy Exposure Registry
- ClinicalTrials.gov ID
- NCT00342862
- Acronym / sponsor ID
- 0485-CL-0002
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Amevive, alefacept, Registry, Psoriasis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Jun 2006 (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.
This is an observational, exposure-registration and follow-up study, to be conducted in the United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the risk of major birth defects.
The AMEVIVE® Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development and will be managed by INC Research. The Registry will be monitored by an independent Advisory Committee of external experts in relevant specialties of teratology, epidemiology, maternal and fetal medicine, and infectious disease medicine (external member details available upon request).
Detailed description
Prospective reports will be collected from pregnant subjects, health care provider (HCP), or Astellas Product Safety Management staff. Data from the pregnant subjects will be collected at 4 to 5 months of pregnancy by telephone interviews with the Registry. The Registry will also contact the subject at 2 months and 12 months after the estimated delivery date (EDD) for post-natal \& pediatric follow-up. The Registry will confirm the information collected from the subject with the HCP by telephone interviews with the Registry, forms mailed/faxed to the Registry, electronic forms/queries sent to the Registry, or a combination of these methods. If a live birth is reported, the infant's HCP will be contacted for the Pediatric Follow-Up at 2 months and 12 months of age. If a birth defect is reported, targeted follow-up will be conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. Amevive Exposure | – | Drug: Amevive exposurePregnant women with psoriasis exposed to AMEVIVE® at any point within 8 weeks prior to conception, or at any time during pregnancy, where the outcome of the pregnancy is unknown prospectively |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with psoriasis exposed to AMEVIVE® at any point within 8 weeks prior to conception, or at any time during pregnancy, where the outcome of the pregnancy is unknown prospectively
Key inclusion criteria (4 listed)
- Have been exposed to AMEVIVE® within 8 weeks prior to conception or at any time during 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, and
- Verbally provide the contact information for herself, her healthcare provider (HCP), and the infant's HCP (if applicable)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Amevive exposureAlso: alefacept, ASP0485Observational | Drug | 1. Amevive Exposure |
Primary outcome
Evaluate pattern or increase in major birth defects in children of women w/ psoriasis who were exposed to AMEVIVE® at any time within the 8 wks prior to conception, or at any time during pregnancy, where outcome of the pregnancy is unknown prospectively
Time frame: At month 4 to 5 of pregnancy; At 2 months and 12 months post estimated delivery date
6 secondary outcomes
To evaluate the number of live born infants versus fetal loss in pregnant women exposed to AMEVIVE®
Time frame: At 2 months post estimated delivery date
To evaluate gestational age, body weight, gender, head circumference, and body length in live born infants exposed to AMEVIVE®
Time frame: At 2 months post estimated delivery date
To evaluate appearance, pulse, grimace, activity, and respiration (APGAR) scores at 1 and 5 minutes of age in live born infants exposed to AMEVIVE®
Time frame: At 2 months post estimated delivery date
To evaluate hospitalizations for infection in live born infants exposed to AMEVIVE®
Time frame: At 2 months and 12 months post estimated delivery date
To evaluate clinically significant infections with unusual organisms, not requiring hospitalization in live born infants exposed to AMEVIVE®
Time frame: At 2 months and 12 months post estimated delivery date
To evaluate malignancies in live born infants exposed to AMEVIVE®
Time frame: At 2 months and 12 months post estimated delivery date
Results and safety
The study was stopped early (reason given: The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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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.
Vice President Medical Affairs study director
Astellas Pharma Global Development
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 Pregnancy, run by Astellas Pharma Inc 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Dec 2013. 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 was stopped early (reason given: The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive). Results are not available in the source record.
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?
Evaluate pattern or increase in major birth defects in children of women w/ psoriasis who were exposed to AMEVIVE® at any time within the 8 wks prior to conception, or at any time during pregnancy, where outcome of the pregnancy is unknown prospectively (time frame: At month 4 to 5 of pregnancy; At 2 months and 12 months post estimated delivery date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2013.