Tofacitinib Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project (OTIS PASS Tofacitinib)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46130
• EU PAS number:
  EUPAS5703
• Study ID:
  46130
• Official title and acronym:
  Tofacitinib Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project (OTIS PASS Tofacitinib)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The Tofacitinib Pregnancy Exposure Registry is a United States-based registry designed to monitor planned or unplanned pregnancies exposed to tofacitinib when used to treat rheumatoid arthritis.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Organization of Teratology Information Specialists (OTIS)

Study timelines

Date when funding contract was signed

Planned: 31/07/2013

Actual: 17/06/2013

Study start date

Planned: 31/08/2013

Actual: 01/11/2013

Data analysis start date

Planned: 01/10/2023

Actual: 01/10/2023

Date of final study report

Planned: 30/03/2024

Actual: 07/03/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%

Study protocol

Initial protocol

A3921203_PROTOCOL_23DEC2013_2

Updated protocol

A3921203_PROTOCOL AMENDMENT 1_V2.0_24JUN2019

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only