Long-term safety study of Rinvoq in RA patients enrolled in the Corrona RA Registry in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47971
• EU PAS number:
  EUPAS39194
• Study ID:
  47971
• Official title and acronym:
  Long-term safety study of Rinvoq in RA patients enrolled in the Corrona RA Registry in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The overall goal of the study is to characterize the safety of Rinvoq in RA patients in the post-approval setting. The primary objective is to compare the incidence of malignancy (excluding non-melanoma skin cancer, NMSC), NMSC, MACE, VTE, SIE, and mortality in adults with RA who receive Rinvoq relative to those who are treated with biologic medications approved for the treatment of RA, in the course of routine clinical care.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned: 09/01/2020

Actual: 09/01/2020

Study start date

Planned: 16/08/2019

Actual: 09/08/2021

Date of final study report

Planned: 16/02/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Study protocol

Initial protocol

p19141-protocol abstract-pmos_Redacted

Updated protocol

P19-141_protocol v3.0_abstract_Redacted

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)

Other study registration identification numbers and links

P19-141