Evaluation of pregnancy and infant outcomes in Kesimpta patients using PRegnancy outcomes Intensive Monitoring (PRIM) data - The Kesimpta-PRIM study. (The Kesimpta PRIM study.)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Study drug and medical condition

• Name of medicine:
  KESIMPTA
• Study drug International non-proprietary name (INN) or common name:
  OFATUMUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA52) ofatumumab

  ofatumumab
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To estimate the proportion of major congenital malformations associated with exposure to Kesimpta during pregnancy among (i) live births and (ii) live births, stillbirths, and termination of pregnancy for fetal anomaly.
• Outcomes:
  Major congenital malformations, Minor congenital malformations Spontanous abortions, stillbirths, elective terminations Adverse birth outcomes: pre-term births, low birth weight, small for gestational age Adverse effects including serious infections (requiring hospitalizations) among infants during the first 12 months after birth
• Data analysis plan:
  Analysis of Kesimpta-PRIM data will include estimation of proportion (and 95% confidence interval) of malformations (major, minor, and overall), and of specific pregnancy outcomes such as, spontaneous abortions, stillbirths and elective terminations. The proportion of congenital malformations will be calculated amongst: (1) live births and (2) live births, stillbirths and termination of pregnancy for fetal anomaly. Proportion will be estimated overall and by pre specified timing of drug exposure in pregnancy. In addition, major congenital malformations will be summarized by SOC based on the latest available MedDRA classifications. Minor congenital malformations will be listed by preferred term based on the latest available MedDRA classification. The proportion of other adverse birth outcomes associated with exposure to Kesimpta during pregnancy including preterm births, low birth weight and small of gestational age will be estimated among live births.