Assessment of pregnancy outcomes in patients treated with reslizumab: Active pregnancy surveillance

Study identification

• EU PAS number:
  EUPAS23021
• Study ID:
  28075
• Official title and acronym:
  Assessment of pregnancy outcomes in patients treated with reslizumab: Active pregnancy surveillance
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Germany

  Netherlands

  United Kingdom
• Study description:
  This is a Phase 4, multinational, non-interventional, active pregnancy surveillance study. The study will provide information on pregnancy outcomes in women with asthma treated with reslizumab during pregnancy in routine clinical practice.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned:14/03/2018

Study start date

Planned:14/03/2018

Actual:14/03/2018

Date of interim report, if expected

Actual:19/10/2018

Date of final study report

Planned:14/03/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Teva Pharmaceutical Ltd.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)