Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

GLATIRAMER ACETATE

Medical condition to be studied

Multiple sclerosis
Breast feeding
Population studied

Short description of the study population

Offspring of mothers with Relapsing Multiple Sclerosis (RMS) who were breast feeding.

Inclusion Criteria
Patients will be included in the study only if they meet all of the following criteria:
- Women with relapsing forms of multiple sclerosis identified by the following:
o Reported diagnosis of RMS
o Pregnancy resulted in live birth
o Reported breastfeeding with no DMT treatment
o Reported breastfeeding under glatiramer acetate
o Gave informed consent and were enrolled into the German Multiple sclerosis and Pregnancy Registry

- Women who have been treated with glatiramer acetate during the breastfeeding period identified by the following:
o Reported glatiramer acetate treatment during entire pregnancy and breastfeeding period OR
o Reported glatiramer acetate treatment initiation during pregnancy and continuation during breastfeeding OR
o Reported glatiramer acetate treatment discontinuation during pregnancy, restart of treatment at some point before delivery and breastfeeding under glatiramer
acetate treatment OR
o Reported glatiramer acetate treatment discontinuation during pregnancy and restart of treatment at some point during breastfeeding OR
o Reported no glatiramer acetate treatment during pregnancy but (re-)start of treatment at some point during breastfeeding
o Reported breastfeeding while under glatiramer acetate treatment for at least one day
- Women who haven’t been treated with any DMT during the breastfeeding period identified by the following:
o Reported DMT discontinuation before conception OR
o Reported DMT discontinuation of glatiramer acetate in the first trimester OR
o Reported no past DMT treatment
o Reported diagnosis of RMS
o Pregnancy resulted in live birth
o Gave informed consent and were enrolled into the German Multiple sclerosis and Pregnancy Registry

Exclusion Criteria
Patients will be excluded from participating in this study if they meet any of the following criteria:
- Women with other forms of multiple sclerosis who breastfed
- Women treated with other DMTs than glatiramer acetate during breastfeeding period

Age groups

Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)

Special population of interest

Pregnant women

Estimated number of subjects

120
Study design details

Main study objective

The objective of study was to assess the outcome of offspring during the initial period of up to 18 months of development who were breastfed by mothers undergoing Glatiramer acetate treatment

Outcomes

-Frequency (no. of events) and incidence (no. of children with events) of hospitalizations. --Frequency and incidence of antibiotic treatments. - Growth parameters: weight, length and head circumference. - Incidence of Pediatrician reports on children development delay (based on routinely measured parameters: turning, attempt to grasp, sitting, turning towards voices, first words, standing).

Data analysis plan

Summary statistics of study outcome measures were displayed by both study cohorts (GA Cohort and Control Cohort) and overall. Potential lack of balance in risk factors between study cohorts were assessed using a by cohort, side-by-side display of descriptive statistics of the risk factors and their 95% confidence intervals.  Incidence tables of binary outcome measures (e.g. proportion of children hospitalized) provided the No. of participants with events and relative percentages as well as the 95% two-sided confidence intervals..  Frequency tables of events (e.g. No. of hospitalizations, No. of relapses) display the annualized number of events as well as its two-sided 95% confidence interval.  Descriptive statistics of continuous outcome measures (e.g. weight, head circumference) at end of follow-up duration will include N, mean, SD, SE, Median, IQR min and max values.
Documents
Study results

EU PAS Register_COBRA study report Synopsis_FINAL approved

English (368.13 KB - PDF)View document