A SECONDARY DATA USE STUDY OF LONG TERM SAFETY OF TOCILIZUMAB BASED ON ANTI RHEUMATIC THERAPY IN SWEDEN (ARTIS) PATIENT REGISTRY

Study identification

• EU PAS number:
  EUPAS23708
• Study ID:
  32844
• Official title and acronym:
  A SECONDARY DATA USE STUDY OF LONG TERM SAFETY OF TOCILIZUMAB BASED ON ANTI RHEUMATIC THERAPY IN SWEDEN (ARTIS) PATIENT REGISTRY
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  This Retrospective Secondary Data Use study is nested within the Anti-Rheumatic Therapy in Sweden (ARTIS) patient registry in Sweden to study the long term safety of tocilizumab in routine clinical practice.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual:06/04/2009

Study start date

Actual:28/04/2009

Date of final study report

Planned:31/03/2019

Actual:19/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche

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

WA22480