Real-world safety of Copaxone in Offsprings of Breastfeeding and treated RMS pAtients – COBRA study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44792
• EU PAS number:
  EUPAS44465
• Study ID:
  44792
• Official title and acronym:
  Real-world safety of Copaxone in Offsprings of Breastfeeding and treated RMS pAtients – COBRA study
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Objective: To assess safety outcomes for offspring breastfed by mothers undergoing glatiramer acetate (GA, Copaxone®) treatment. Methods: This retrospective study used German Multiple Sclerosis and Pregnancy Registry data. Eligible participants had RMS, a live birth, and received GA or no DMT during breastfeeding.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 17/12/2019

Actual: 17/12/2019

Study start date

Planned: 30/04/2020

Actual: 13/05/2020

Data analysis start date

Planned: 15/06/2020

Actual: 21/08/2020

Date of final study report

Planned: 15/08/2020

Actual: 03/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Teva Pharmaceuticals B.V.

Study protocol

Initial protocol

EU PAS register_COBRA protocol redacted_FINAL approved

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable