An Active Surveillance, Post Authorization Safety Study (PASS) of Serious Infection, Malignancy, Cardiovascular (CV) and Other Safety Events of Interest among Patients Treated with Tofacitinib for Moderately to Severely Active Rheumatoid Arthritis (RA) within the Swedish, Population based, Anti Rheumatic Treatment in Sweden (ARTIS) register. (Safety of tofacitinib in ARTIS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49403
• EU PAS number:
  EUPAS31157
• Study ID:
  49403
• Official title and acronym:
  An Active Surveillance, Post Authorization Safety Study (PASS) of Serious Infection, Malignancy, Cardiovascular (CV) and Other Safety Events of Interest among Patients Treated with Tofacitinib for Moderately to Severely Active Rheumatoid Arthritis (RA) within the Swedish, Population based, Anti Rheumatic Treatment in Sweden (ARTIS) register. (Safety of tofacitinib in ARTIS)
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  Rationale and Background: Tofacitinib is a potent, selective inhibitor of the Janus kinase (JAK) family of kinases with a high degree of selectivity relative to other kinases in the human genome. Tofacitinib was approved in the European Union (EU) in March 2017 at a dose of 5 milligrams (mg) administered twice daily (BID) for the treatment of adult patients with moderately to severely active RA who have responded inadequately to, or who are intolerant to, one or more disease modifying antirheumatic drugs (DMARDs). To enable assessment of safety events of special interest including rare events and endpoints with long latency periods, Pfizer will implement a post approval, active surveillance study of tofacitinib exposed patients using actively collected prospective data included in the ARTIS register. Research Question: What are the rates of safety events of special interest in RA patients treated with tofacitinib and among RA patients treated with other advanced targeted therapies?
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Actual: 28/05/2018

Study start date

Actual: 01/09/2019

Date of interim report, if expected

Planned: 14/03/2021

Date of final study report

Planned: 14/08/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

pfizer

Study protocol

Initial protocol

A3921314 Final Non-Interventional Protocol, 20 August 2019

Updated protocol

A3921314_PROTOCOL- ARTIS PASS _V4.0_22FEB2023

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)