Multiple SclerosisNCT06156683
Kesimpta Pregnancy and Infant Safety Study Using Real World Data
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
The study is an observational retrospective cohort study using longitudinal secondary data. Pregnant women with MS are assessed for exposure to Kesimpta and other MS disease modifying drugs (MSDMD) and followed up for adverse pregnancy and infant outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Multiple sclerosis disease modifying drug
- How many people
- 1,500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jun 2024to 1 Feb 2028
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The overall study population consists of women with MS with a recorded pregnancy outcome during the inclusion period. Pregnancies exposed to MSDMDs with a known teratogenic effect or non-MSDMDs with a known moderate to high teratogenic effect are excluded.
Who may be able to join
- The following overall criteria for study inclusion are applied:
- Pregnancy with a recorded start and end of pregnancy outcome (live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy) during the inclusion period
- Age 18-49 years at index date
- A diagnosis of MS before the index date. This inclusion criterion is based on diagnosis codes, as recorded in the different data sources
- Availability of information on exposure to MSDMDs and maternal baseline characteristics for a minimum of 12 months before the index date
- In addition, the following outcome and objective specific inclusion criteria are applied:
Show all 12Show fewer
- For analyses of MCMs in live births (primary objective): pregnancy ending in at least one live birth
- For analyses of spontaneous abortion, elective termination of pregnancy, stillbirth, preeclampsia, eclampsia (secondary objectives): pregnancy ending in at least one live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy
- For analyses of preterm birth, SGA (secondary objectives): pregnancy ending in at least one live birth
- For analyses of MCMs among live births, spontaneous abortions, stillbirths, and elective terminations (exploratory objective): pregnancy ending in at least one live birth, spontaneous abortion, still birth, or elective termination
- For analyses of neonatal infection: live newborn
- For analyses of SII: newborn alive at 29 days after birth
Who cannot join
- The following overall criteria for exclusion are applied:
- Pregnancy exposed to a MSDMD that have a known teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance
- Pregnancy exposed to a non-MSDMD that have a known moderate to high teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance
- The following outcome specific exclusion criteria are applied:
- For analyses of MCMs and exploratory analyses of MCMs: pregnancies with a record of a chromosomal abnormality or a genetic syndrome
- For analyses of preterm birth, pre-eclampsia, eclampsia and SGA, pregnancies involving multiples
- For Kesimpta and MSDMD-exposed cohorts: pregnancies not exposed during the outcome specific risk period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
Switzerland1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Basel
About this study
Official title: Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data
The study is an observational retrospective cohort study using longitudinal secondary data. Pregnant women with MS are assessed for exposure to Kesimpta and other MS disease modifying drugs (MSDMD) and followed up for adverse pregnancy and infant outcomes.
Read the detailed description
Outcomes among Kesimpta exposed pregnancies are compared primarily to MSDMD-exposed pregnancies and secondarily to MSDMD-unexposed pregnancies.
The main research question is to determine whether the exposure during pregnancy to Kesimpta increases the risk of adverse pregnancy and infant outcomes in women with MS.
The risk period is defined as the 1st trimester of pregnancy for analyses of Major congenital malformations and the entire duration of pregnancy for all other outcomes.
The data for this study is retrieved from data sources from Denmark, Sweden, and the US, based on an assessment of feasibility.
- Conditions
- Multiple Sclerosis
- Being tested
- Multiple sclerosis disease modifying drug
- Keywords
- Kesimpta, ofatumumab, real world data
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple sclerosis disease modifying drugOther
There is no treatment allocation. Women with multiple sclerosis with a recorded pregnancy outcome during the inclusion period will be recruited.
| Study group | Role | What they receive |
|---|---|---|
| Kesimpta-exposed | exposure to Kesimpta during the risk period Receives: Other: Multiple sclerosis disease modifying drug | |
| MSDMD-exposed | exposure to at least one Multiple sclerosis disease modifying drug (MSDMD) (other than Kesimpta) during the risk period Receives: Other: Multiple sclerosis disease modifying drug | |
| MSDMD-unexposed | no exposure to Kesimpta or any other Multiple sclerosis disease modifying drug (MSDMD) during the risk period Receives: Other: Multiple sclerosis disease modifying drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major congenital malformations (MCM) among live births
The primary outcome of interest concerns MCMs occurring in pregnancies ending in at least one live birth. MCMs are defined as defects that have either cosmetic or functional significance to the child (e.g., a cleft lip)
Measured: First year of life, up to 12 months
Secondary outcomes (7)
Number of participants with spontaneous abortions
Also termed miscarriage, is defined as the unintended loss of an intrauterine pregnancy less than 20 weeks of gestation (<20 weeks).
Measured: Up to 9 months
Number of participants with elective termination of pregnancy
Defined as the intentional termination of pregnancy at any time in gestation for any reason. When possible, reasons for elective termination are captured and classified as elective termination of pregnancy for fetal anomaly or for other reasons.
Measured: Up to 9 months
Number of participants with stillbirths
Defined as the unintended fetal death occurring at or after 20 weeks of gestation.
Measured: Up to 9 months
Number of participants with preterm births
Defined as live births less than 37 weeks of gestation (<37 weeks). Elective caesarean deliveries or inductions prior to 37 completed weeks will be described separately.
Measured: Up to 9 months
Number of participants with preeclampsia
Preeclampsia is defined as the new-onset of hypertension with a systolic blood pressure greater than or equal to 140 mmHg and/or diastolic blood pressure greater than or equal to 90 mmHg at or after 20 weeks of gestation with proteinuria and/or endorgan dysfunction (renal dysfunction, liver dysfunction, central nervous system disturbances, pulmonary edema, and thrombocytopenia).
Measured: Up to 9 months
Number of participants with eclampsia
Eclampsia is defined as the new onset of generalized tonic-clonic seizures in a woman with preeclampsia
Measured: Up to 9 months
Number of participants small for gestational age (SGA)
Defined as a birth weight lower than the 10th percentile for gestational age and sex using the national standards in each study country in a live birth
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start30 Jun 2024
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156683
- Sponsor's protocol ID
- COMB157G2405
- Other IDs
- EUPAS106133
- Status last verified
- Jul 2024
- First submitted
- 27 Nov 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data
- ClinicalTrials.gov ID
- NCT06156683
- Acronym / sponsor ID
- COMB157G2405
- Conditions
- Multiple Sclerosis
- Keywords
- Kesimpta, ofatumumab, real world data
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 5 Dec 2023 (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.
The study is an observational retrospective cohort study using longitudinal secondary data. Pregnant women with MS are assessed for exposure to Kesimpta and other MS disease modifying drugs (MSDMD) and followed up for adverse pregnancy and infant outcomes.
Detailed description
Outcomes among Kesimpta exposed pregnancies are compared primarily to MSDMD-exposed pregnancies and secondarily to MSDMD-unexposed pregnancies.
The main research question is to determine whether the exposure during pregnancy to Kesimpta increases the risk of adverse pregnancy and infant outcomes in women with MS.
The risk period is defined as the 1st trimester of pregnancy for analyses of Major congenital malformations and the entire duration of pregnancy for all other outcomes.
The data for this study is retrieved from data sources from Denmark, Sweden, and the US, based on an assessment of feasibility.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kesimpta-exposed | – | Other: Multiple sclerosis disease modifying drugexposure to Kesimpta during the risk period |
| MSDMD-exposed | – | Other: Multiple sclerosis disease modifying drugexposure to at least one Multiple sclerosis disease modifying drug (MSDMD) (other than Kesimpta) during the risk period |
| MSDMD-unexposed | – | Other: Multiple sclerosis disease modifying drugno exposure to Kesimpta or any other Multiple sclerosis disease modifying drug (MSDMD) during the risk period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The overall study population consists of women with MS with a recorded pregnancy outcome during the inclusion period. Pregnancies exposed to MSDMDs with a known teratogenic effect or non-MSDMDs with a known moderate to high teratogenic effect are excluded.
Key inclusion criteria (12 listed)
- Pregnancy with a recorded start and end of pregnancy outcome (live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy) during the inclusion period
- Age 18-49 years at index date
- A diagnosis of MS before the index date. This inclusion criterion is based on diagnosis codes, as recorded in the different data sources
- Availability of information on exposure to MSDMDs and maternal baseline characteristics for a minimum of 12 months before the index date
- For analyses of MCMs in live births (primary objective): pregnancy ending in at least one live birth
Key exclusion criteria (7 listed)
- Pregnancy exposed to a MSDMD that have a known teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance
- Pregnancy exposed to a non-MSDMD that have a known moderate to high teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance
- For analyses of MCMs and exploratory analyses of MCMs: pregnancies with a record of a chromosomal abnormality or a genetic syndrome
- For analyses of preterm birth, pre-eclampsia, eclampsia and SGA, pregnancies involving multiples
- For Kesimpta and MSDMD-exposed cohorts: pregnancies not exposed during the outcome specific risk period
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 |
|---|---|---|
| Multiple sclerosis disease modifying drugThere is no treatment allocation. Women with multiple sclerosis with a recorded pregnancy outcome during the inclusion period will be recruited. | Other | Kesimpta-exposed, MSDMD-exposed, MSDMD-unexposed |
Primary outcome
Number of major congenital malformations (MCM) among live births
Time frame: First year of life, up to 12 months
The primary outcome of interest concerns MCMs occurring in pregnancies ending in at least one live birth. MCMs are defined as defects that have either cosmetic or functional significance to the child (e.g., a cleft lip)
7 secondary outcomes
Number of participants with spontaneous abortions
Time frame: Up to 9 months
Number of participants with elective termination of pregnancy
Time frame: Up to 9 months
Number of participants with stillbirths
Time frame: Up to 9 months
Number of participants with preterm births
Time frame: Up to 9 months
Number of participants with preeclampsia
Time frame: Up to 9 months
Number of participants with eclampsia
Time frame: Up to 9 months
Number of participants small for gestational age (SGA)
Time frame: Up to 9 months
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 1 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in Switzerland.
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 12 inclusion and 7 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 1 Aug 2024. 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 Switzerland. 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 Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of major congenital malformations (MCM) among live births (time frame: First year of life, up to 12 months). 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 1 Aug 2024.