Rheumatoid ArthritisNCT01087125
Abatacept Pregnancy Exposure Registry
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of the abatacept pregnancy registry is to monitor planned and unplanned pregnancies exposed to abatacept, to evaluate the possible teratogenic effects (that is, any abnormal development) of this medication in the pregnancy outcome and to follow live born infants for one year after birth. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2006to 31 Dec 2019
- 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
Who may be able to join
- Currently pregnant women who agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants
Who cannot join
- Women who come in first contact with the project after prenatal diagnosis of a fetal abnormality
Trial locations and contacts
1 site in 1 country.
United States1 site
Bristol-Myers Squibb, Active
Princeton, New Jersey, 08540
About this study
Official title: Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study
The purpose of the abatacept pregnancy registry is to monitor planned and unplanned pregnancies exposed to abatacept, to evaluate the possible teratogenic effects (that is, any abnormal development) of this medication in the pregnancy outcome and to follow live born infants for one year after birth.
- Conditions
- Rheumatoid Arthritis
- Being tested
- No Interventions
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsDrug
No Interventions
| Study group | Role | What they receive |
|---|---|---|
| Pregnant RA patients with abatacept exposure during pregnancy | Not described Receives: Drug: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major structural birth defects of newborns
Measured: Throughout pregnancy and up to 1 year of life
Secondary outcomes (6)
3 or more minor structural defects
Measured: at dysmorphological exam
Spontaneous abortion
Measured: throughout pregnancy
Premature delivery
Measured: throughout pregnancy
Small for gestational age
Measured: at birth
Postnatal growth deficiency
Measured: throughout pregnancy and up to 1 year of life
Postnatal serious infections, hospitalizations or malignancies
Measured: 1st year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study start1 Sep 2006
- Primary completion31 Oct 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, The Organization of Teratology Information Specialists
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087125
- Sponsor's protocol ID
- IM101-121
- Status last verified
- Jul 2023
- First submitted
- 12 Mar 2010
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study
- ClinicalTrials.gov ID
- NCT01087125
- Acronym / sponsor ID
- IM101-121
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, The Organization of Teratology Information Specialists
- Study start
- 1 Sep 2006 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Mar 2010 (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 purpose of the abatacept pregnancy registry is to monitor planned and unplanned pregnancies exposed to abatacept, to evaluate the possible teratogenic effects (that is, any abnormal development) of this medication in the pregnancy outcome and to follow live born infants for one year after birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant RA patients with abatacept exposure during pregnancy | – | Drug: No Interventions |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (1 listed)
- Currently pregnant women who agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants
Key exclusion criteria (1 listed)
- Women who come in first contact with the project after prenatal diagnosis of a fetal abnormality
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 |
|---|---|---|
| No InterventionsNo Interventions | Drug | Pregnant RA patients with abatacept exposure during pregnancy |
Primary outcome
Major structural birth defects of newborns
Time frame: Throughout pregnancy and up to 1 year of life
6 secondary outcomes
3 or more minor structural defects
Time frame: at dysmorphological exam
Spontaneous abortion
Time frame: throughout pregnancy
Premature delivery
Time frame: throughout pregnancy
Small for gestational age
Time frame: at birth
Postnatal growth deficiency
Time frame: throughout pregnancy and up to 1 year of life
Postnatal serious infections, hospitalizations or malignancies
Time frame: 1st year of life
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 20 Jul 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Rheumatoid Arthritis, run by Bristol-Myers Squibb 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 1 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: finished, as of the sponsor's last update on 20 Jul 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 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?
Major structural birth defects of newborns (time frame: Throughout pregnancy and up to 1 year of life). 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 20 Jul 2023.