COMPARATIVE SAFETY OF TOCILIZUMAB VERSUS OTHER BIOLOGIC DMARDS IN PATIENTS WITH RHEUMATOID ARTHRITIS: A LARGE MULTI-DATABASE COHORT STUDY

Study identification

• EU PAS number:
  EUPAS19948
• Study ID:
  29792
• Official title and acronym:
  COMPARATIVE SAFETY OF TOCILIZUMAB VERSUS OTHER BIOLOGIC DMARDS IN PATIENTS WITH RHEUMATOID ARTHRITIS: A LARGE MULTI-DATABASE COHORT STUDY
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Because the majority of previous safety studies on TCZ did not include a direct comparison to a different biologic drug, a large, high-quality population-representative evidence on comparative safety of TCZ versus other biologics for RA on the risk of serious infection and malignancy is needed.This study will be performed within multiple large healthcare administrative claims databases based in the US. The data sources are Medicare (2008-2015), IMS PharMetrics (2006-2015) and Truven MarketScan (2009-2015) databases.
• Study status:
  Finalised

Research institutions and networks

Institutions

NA

Study timelines

Date when funding contract was signed

Planned:04/08/2017

Actual:02/08/2017

Study start date

Planned:15/08/2017

Actual:14/09/2017

Date of final study report

Planned:12/06/2018

Actual:17/10/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

MA39102