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NCT Number: NCT06156683

Kesimpta 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Novartis Investigative Site

Basel, Switzerland

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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:

  • 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

Exclusion criteria

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

Treatment and study plan

Multiple sclerosis disease modifying drug

Other

There is no treatment allocation. Women with multiple sclerosis with a recorded pregnancy outcome during the inclusion period will be recruited.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Number of participants with spontaneous abortions

    Time frame: Up to 9 months

    Also termed miscarriage, is defined as the unintended loss of an intrauterine pregnancy less than 20 weeks of gestation (<20 weeks).

  2. Number of participants with elective termination of pregnancy

    Time frame: Up to 9 months

    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.

  3. Number of participants with stillbirths

    Time frame: Up to 9 months

    Defined as the unintended fetal death occurring at or after 20 weeks of gestation.

  4. Number of participants with preterm births

    Time frame: Up to 9 months

    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.

  5. Number of participants with preeclampsia

    Time frame: Up to 9 months

    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).

  6. Number of participants with eclampsia

    Time frame: Up to 9 months

    Eclampsia is defined as the new onset of generalized tonic-clonic seizures in a woman with preeclampsia

  7. Number of participants small for gestational age (SGA)

    Time frame: Up to 9 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 5, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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