Systemic Lupus ErythematosusROSENCT07049653
Anifrolumab Pregnancy Study
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca at 1 site in United States.
Trial summary
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab. Read more about this study
- Who is it for?
- Ages 18 to 130 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2026to 10 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 130 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The population will encompass women with SLE of child-bearing potential age (15-49 years old) who start anifrolumab or other selected SLE treatments. For the safety outcomes analyses the study population will include pregnant women and their infant born anytime during the study period.
Who may be able to join
- Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
- Women diagnosed with SLE before pregnancy
- Women exposed to anifrolumab (polytherapy, added to SLE SOC) during pregnancy and/or 16-week period prior to LMP2
- Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
- Women diagnosed with SLE before pregnancy
- Women treated with SLE SOC during pregnancy
Who cannot join
- Pregnancies whose date of conception cannot be established
- Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2
- Pregnancies whose date of conception cannot be established
- Inclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:
- Women with moderate/severe SLE
- Exclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:
- Women with a history of CM or chromosomal abnormalities (according to available records), before delivery
- Women prescribed a confirmed teratogenic drug prior to LMP2 with a time period of 5-half-lives of relevant drug or during pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
United States1 site, 1 recruiting
- Recruiting
Research Site
Cary, North Carolina, 27513
About this study
Official title: A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
Read the detailed description
The aim of this study is to describe congenital malformations, adverse pregnancy and birth outcomes in pregnancies/offspring from women with moderate/severe SLE exposed to anifrolumab during pregnancy and to compare with outcomes in women with moderate/severe SLE who are exposed to other standard of care but not anifrolumab. Adverse outcomes related to infant growth up to one year of age will also be investigated.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- pregnancy, anifrolumab, SLE
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed cohort | Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy | |
| Unexposed cohort | Pregnant individuals with a diagnosis of moderate/severe SLE who are not exposed to anifrolumab at any time during pregnancy but who are exposed to other products for the treatment of SLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of major congenital malformations (MCM)
Describe and estimate the risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy
Measured: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Relative risk of MCM
Estimate the relative risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy
Measured: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Risk of select pregnancy loss outcomes
Describe and estimate the risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in all pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy
Measured: At delivery/birth
Relative risk of select pregnancy loss outcomes
Estimate the relative risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy
Measured: At delivery/birth
Secondary outcomes (7)
Demographic and clinical characteristics
Describe the demographic and clinical characteristics of the live and non-live offspring and their mothers who had moderate/severe SLE and were exposed or unexposed to anifrolumab during the first trimester of pregnancy or anytime during pregnancy
Measured: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Risk of minor congenital malformations (mCM)
Describe and estimate the risk of mCM in live and non-live offspring from women with moderate/severe SLE who were exposed or unexposed to anifrolumab during pregnancy
Measured: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Relative risk of mCM
Estimate the relative risk of mCM in live and non-live offspring from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy
Measured: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Risk of adverse pregnancy outcomes
Describe and estimate the risk of adverse pregnancy outcomes (ectopic pregnancy, spontaneous abortion, elective termination of pregnancy, stillbirth, infections requiring hospitalisation during pregnancy, emergency caesarean section) in all pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy
Measured: At delivery/birth
Relative risk of adverse pregnancy outcomes
Estimate the relative risk of adverse pregnancy outcomes (ectopic pregnancy, spontaneous abortion, elective termination of pregnancy, stillbirth, infections requiring hospitalisation during pregnancy, emergency caesarean section) in pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy
Measured: At delivery/birth
Risk of adverse birth outcomes
Describe and estimate the risk of adverse birth outcomes (preterm birth,
small for gestational age (SGA)) in live offspring from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy
Measured: At delivery/birth
Relative risk of adverse birth outcomes
Estimate the relative risk of adverse birth outcomes (preterm birth, small for gestational age (SGA)) in live offspring from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy
Measured: At delivery/birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start4 Jun 2026
- Primary completion10 Dec 2030 (estimated)
- Study completion10 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049653
- Sponsor's protocol ID
- D3461R00028
- Acronym
- ROSE
- Status last verified
- Sep 2026
- First submitted
- 23 May 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab
- ClinicalTrials.gov ID
- NCT07049653
- Acronym / sponsor ID
- ROSE / D3461R00028
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- pregnancy, anifrolumab, SLE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 10 Dec 2030 (estimated)
- Study completion
- 10 Dec 2030 (estimated)
- First posted
- 3 Jul 2025 (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.
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
Detailed description
The aim of this study is to describe congenital malformations, adverse pregnancy and birth outcomes in pregnancies/offspring from women with moderate/severe SLE exposed to anifrolumab during pregnancy and to compare with outcomes in women with moderate/severe SLE who are exposed to other standard of care but not anifrolumab. Adverse outcomes related to infant growth up to one year of age will also be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed cohort | – | –Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy |
| Unexposed cohort | – | –Pregnant individuals with a diagnosis of moderate/severe SLE who are not exposed to anifrolumab at any time during pregnancy but who are exposed to other products for the treatment of SLE |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will encompass women with SLE of child-bearing potential age (15-49 years old) who start anifrolumab or other selected SLE treatments. For the safety outcomes analyses the study population will include pregnant women and their infant born anytime during the study period.
Key inclusion criteria (6 listed)
- Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
- Women diagnosed with SLE before pregnancy
- Women exposed to anifrolumab (polytherapy, added to SLE SOC) during pregnancy and/or 16-week period prior to LMP2
- Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
- Women diagnosed with SLE before pregnancy
Key exclusion criteria (8 listed)
- Pregnancies whose date of conception cannot be established
- Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2
- Pregnancies whose date of conception cannot be established
- Women with moderate/severe SLE
- Women with a history of CM or chromosomal abnormalities (according to available records), before delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk of major congenital malformations (MCM)
Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Describe and estimate the risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy
Relative risk of MCM
Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Estimate the relative risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy
Risk of select pregnancy loss outcomes
Time frame: At delivery/birth
Describe and estimate the risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in all pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy
Relative risk of select pregnancy loss outcomes
Time frame: At delivery/birth
Estimate the relative risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy
7 secondary outcomes
Demographic and clinical characteristics
Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Risk of minor congenital malformations (mCM)
Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Relative risk of mCM
Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Risk of adverse pregnancy outcomes
Time frame: At delivery/birth
Relative risk of adverse pregnancy outcomes
Time frame: At delivery/birth
Risk of adverse birth outcomes
Time frame: At delivery/birth
Relative risk of adverse birth outcomes
Time frame: At delivery/birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
AstraZeneca Clinical Study Information Center contact
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 Systemic Lupus Erythematosus, run by AstraZeneca 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of major congenital malformations (MCM) (time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births). The study lists 4 primary outcomes in all. 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 18 Sep 2026.