Multiple SclerosisNCT05634967
Kesimpta (Ofatumumab) Pregnancy Registry
An observational study of Multiple Sclerosis and Pregnancy, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Pregnancy
- What is being tested?
- Kesimpta
- How many people
- 725 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 28 Feb 2033
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants from sub-studies, namely the Kesimpta-OTIS sub-study and Kesimpta-DMSKW sub-study, of identical design, conducted in parallel, enrolling pregnant women (MS and non-MS) residing in US or Canada and pregnant women (MS only) from Germany respectively.
Who may be able to join
- Participants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry:
- Cohort 1: Kesimpta-Exposed Cohort
- Pregnant women
- Diagnosed with MS, with the indication validated by medical records when possible
- Administered Kesimpta for the treatment of MS at any time from 166 days prior to the first day of the LMP, or up to and including the end of pregnancy
- Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children
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- Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
- Pregnant women
- Diagnosed with MS, with the indication validated by medical records when possible
- May or may not have taken another medication for MS in the current pregnancy
- Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children
- Cohort 3: Healthy Comparison Cohort (Comparison Group 2):Kesimpta-OTIS sub-study specific
- Pregnant women
- Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and validated developmental performance questionnaire in live born children
Who cannot join
- Women meeting any of the following criteria will be excluded from the cohort study:
- Cohort 1: Kesimpta-Exposed Cohort
- Women who have enrolled in the Kesimpta cohort study with a previous pregnancy
- Women who have used Kesimpta for an indication other than a currently approved indication
- Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) prior to conception:
- Other anti-CD20 monoclonal antibody: same class as Kesimpta
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- S1P modulators: same class as Mayzent
- Cladribine (Mavenclad): Based on the US label, animal studies indicate that there is positive evidence of teratogenicity for Cladribine
- Teriflunomide (Aubagio): The teratogenecity of teriflunomide is unknown and currently under investigation.
- New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.
- Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
- Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
- Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
- Administered Kesimpta 166 days before the first day of LMP or anytime during pregnancy
- Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) of conception:
- Anti CD-20 monoclonal antibody
- Cladribine (Mavenclad)
- S1P modulators
- Teriflunomide (Aubagio) New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.
- Women who have enrolled in the Kesimpta cohort or BAF312A2403 Mayzent cohort with a previous pregnancy
- Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
- Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
- Cohort 3: Healthy Comparison Cohort (Comparison Group 2): Only applicable to Kesimpta-OTIS sub-study
- Administered Kesimpta 166 days before or Mayzent 4 days after the first day of LMP or anytime during pregnancy
- Women who have a diagnosis of a MS
- Women who have a current diagnosis of any autoimmune disease
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Women treated with Mayzent or Kesimpta for non-MS indication
- Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
- Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
- Women exposed to a known human teratogenic drugs 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.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego OTIS
La Jolla, California, 92093-0934
877-311-8972
Diana Johnson
About this study
Official title: Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated With Kesimpta (Ofatumumab) Using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry
The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.
Read the detailed description
The study is expected to enroll for approximately 7 years and follow the pregnant women and their infant(s) over a maximum of 21 months.
The study will be conducted as two sub-studies leveraging independent ongoing pregnancy registries:
- The Organization of Teratology Information Specialists (OTIS) Research Group, University of California, San Diego, USA (referred to as "OTIS") will serve as data source for the Kesimpta-OTIS sub-study;
- The German MS and pregnancy registry - Deutschsprachigen Multiple Sklerose und Kinderwunsch Register (DMSKW) at Katholisches Klinikum Bochum gGmbH, St Josef Hospital, Bochum, Germany (referred to as "DMSKW") will serve as data source for the Kesimpta- DMSKW sub-study.
Both registries will independently collect and assess data related to the pregnancy and infant outcomes of interest and provide aggregate data which will be further combined (metaanalyses) by Novartis (referred to as the Sponsor) or a designated contract research organization (CRO).
- Conditions
- Multiple Sclerosis, Pregnancy
- Being tested
- Kesimpta
- Keywords
- PASS, Kesimpta, ofatumumab, Pregnancy, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KesimptaOther
Also called Ofatumumab
Prospective non-interventional study. There is no treatment allocation. Patients participating in from the two independent sub-studies, namely the Kesimpta-OTIS sub-study and Kesimpta-DMSKW sub-study, of identical design, conducted in parallel, enrolling pregnant women (MS and non-MS) residing in US or Canada and pregnant women (MS only) from Germany respectively are eligible for enrolling to this study.
| Study group | Role | What they receive |
|---|---|---|
| Disease-matched cohort (Comparison Group 1) | comparison group consisting of women diagnosed with MS who have not used Kesimpta during pregnancy (unexposed disease-matched comparison group). | |
| Healthy cohort (only applicable in the Kesimpta-OTIS sub-study) (Comparison Group 2) | healthy women who are not diagnosed with MS or any other autoimmune disease, have not had exposure to a known human teratogen, and have not taken Kesimpta in pregnancy (healthy comparison group). Since the DMSKW register is an MS population specific register that does not collect data on non-MS population, this cohort is only applicable in the Kesimpta-OTIS sub-study. | |
| Kesimpta-exposed cohort | women and infants who are exposed to Kesimpta during pregnancy to treat MS. Receives: Other: Kesimpta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with major structural defects
Number of participants with major structural defects will be collected
Measured: Up to 21 months
Secondary outcomes (11)
Number of participants with spontaneous abortion/miscarriage
Number of participants with spontaneous abortion/miscarriage will be collected
Measured: Up to 21 months
Number of stillbirth cases
Number of stillbirth cases will be collected
Measured: Up to 21 months
Number of elective termination cases
Number of elective termination cases will be collected
Measured: Up to 21 months
Number of preterm delivery cases
Number of preterm delivery cases will be collected
Measured: Up to 21 months
Number of preeclampsia / eclampsia cases
Number of preeclampsia / eclampsia cases will be collected
Measured: Up to 21 months
Number of cases with pattern of 3 or more minor structural defects
Number of cases with pattern of 3 or more minor structural defects will be collected
Measured: Up to 21 months
Number of participants small for gestational age
Number of participants small for gestational age will be collected
Measured: Up to 21 months
Number of participants with postnatal growth small for age at one year of age
Number of participants with postnatal growth small for age at one year of age will be collected
Measured: Up to 21 months
Developmental performance at approximately one year of age: Michaelis developmental milestones questionnaires
The Michaelis developmental milestones questionnaires will be used to assess the developmental performance in live born infants.
Measured: Up to 21 months
Developmental performance at approximately one year of age: Denver developmental screening test
Denver developmental screening test will be used to assess the developmental performance in live born infants;
Measured: Up to 21 months
Number of serious or opportunistic infections in the first year of life.
Number of serious or opportunistic infections in the first year of life will be collected
Measured: Up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start5 Jan 2023
- Primary completion28 Feb 2033 (estimated)
- Study completion28 Feb 2033 (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
- Prospective
- Enrolment
- 725 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
- NCT05634967
- Sponsor's protocol ID
- COMB157G2403
- Status last verified
- Jan 2025
- First submitted
- 22 Nov 2022
- Last updated
- 14 Jan 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated With Kesimpta (Ofatumumab) Using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry
- ClinicalTrials.gov ID
- NCT05634967
- Acronym / sponsor ID
- COMB157G2403
- Conditions
- Multiple Sclerosis, Pregnancy
- Keywords
- PASS, Kesimpta, ofatumumab, Pregnancy, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 725 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 28 Feb 2033 (estimated)
- Study completion
- 28 Feb 2033 (estimated)
- First posted
- 2 Dec 2022 (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 Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.
Detailed description
The study is expected to enroll for approximately 7 years and follow the pregnant women and their infant(s) over a maximum of 21 months.
The study will be conducted as two sub-studies leveraging independent ongoing pregnancy registries:
- The Organization of Teratology Information Specialists (OTIS) Research Group, University of California, San Diego, USA (referred to as "OTIS") will serve as data source for the Kesimpta-OTIS sub-study;
- The German MS and pregnancy registry - Deutschsprachigen Multiple Sklerose und Kinderwunsch Register (DMSKW) at Katholisches Klinikum Bochum gGmbH, St Josef Hospital, Bochum, Germany (referred to as "DMSKW") will serve as data source for the Kesimpta- DMSKW sub-study.
Both registries will independently collect and assess data related to the pregnancy and infant outcomes of interest and provide aggregate data which will be further combined (metaanalyses) by Novartis (referred to as the Sponsor) or a designated contract research organization (CRO).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Disease-matched cohort (Comparison Group 1) | – | –comparison group consisting of women diagnosed with MS who have not used Kesimpta during pregnancy (unexposed disease-matched comparison group). |
| Healthy cohort (only applicable in the Kesimpta-OTIS sub-study) (Comparison Group 2) | – | –healthy women who are not diagnosed with MS or any other autoimmune disease, have not had exposure to a known human teratogen, and have not taken Kesimpta in pregnancy (healthy comparison group). Since the DMSKW register is an MS population specific register that does not collect data on non-MS population, this cohort is only applicable in the Kesimpta-OTIS sub-study. |
| Kesimpta-exposed cohort | – | Other: Kesimptawomen and infants who are exposed to Kesimpta during pregnancy to treat MS. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from sub-studies, namely the Kesimpta-OTIS sub-study and Kesimpta-DMSKW sub-study, of identical design, conducted in parallel, enrolling pregnant women (MS and non-MS) residing in US or Canada and pregnant women (MS only) from Germany respectively.
Key inclusion criteria (14 listed)
- Participants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry:
- Cohort 1: Kesimpta-Exposed Cohort
- Pregnant women
- Diagnosed with MS, with the indication validated by medical records when possible
- Administered Kesimpta for the treatment of MS at any time from 166 days prior to the first day of the LMP, or up to and including the end of pregnancy
Key exclusion criteria (31 listed)
- Cohort 1: Kesimpta-Exposed Cohort
- Women who have enrolled in the Kesimpta cohort study with a previous pregnancy
- Women who have used Kesimpta for an indication other than a currently approved indication
- Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) prior to conception:
- Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)
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 |
|---|---|---|
| KesimptaAlso: OfatumumabProspective non-interventional study. There is no treatment allocation. Patients participating in from the two independent sub-studies, namely the Kesimpta-OTIS sub-study and Kesimpta-DMSKW sub-study, of identical design, conducted in parallel, enrolling pregnant women (MS and non-MS) residing in US or Canada and pregnant women (MS only) from Germany respectively are eligible for enrolling to this study. | Other | Kesimpta-exposed cohort |
Primary outcome
Number of participants with major structural defects
Time frame: Up to 21 months
Number of participants with major structural defects will be collected
11 secondary outcomes
Number of participants with spontaneous abortion/miscarriage
Time frame: Up to 21 months
Number of stillbirth cases
Time frame: Up to 21 months
Number of elective termination cases
Time frame: Up to 21 months
Number of preterm delivery cases
Time frame: Up to 21 months
Number of preeclampsia / eclampsia cases
Time frame: Up to 21 months
Number of cases with pattern of 3 or more minor structural defects
Time frame: Up to 21 months
Number of participants small for gestational age
Time frame: Up to 21 months
Number of participants with postnatal growth small for age at one year of age
Time frame: Up to 21 months
Developmental performance at approximately one year of age: Michaelis developmental milestones questionnaires
Time frame: Up to 21 months
Developmental performance at approximately one year of age: Denver developmental screening test
Time frame: Up to 21 months
Number of serious or opportunistic infections in the first year of life.
Time frame: Up to 21 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 14 Jan 2025.
- MotherToBaby Pregnancy Studies are observational studies coordinated at the University of California San Diego. Our studies are currently enrolling pregnant women in a study examining the use of medications to treat multiple sclerosis during pregnancy.Link provided by the sponsor.
- 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 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 and Pregnancy, run by Novartis Pharmaceuticals 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 14 inclusion and 31 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 14 Jan 2025. 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 Novartis Pharmaceuticals (1-888-669-6682, 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 participants with major structural defects (time frame: Up to 21 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 14 Jan 2025.