OBSERVATIONAL SAFETY AND EFFECTIVENESS STUDY OF PATIENTS WITH POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS TREATED WITH TOCILIZUMAB

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49484
• EU PAS number:
  EUPAS10547
• Study ID:
  49484
• Official title and acronym:
  OBSERVATIONAL SAFETY AND EFFECTIVENESS STUDY OF PATIENTS WITH POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS TREATED WITH TOCILIZUMAB
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Germany

  United States
• Study description:
  This protocol describes the collection, analysis, and reporting of aggregate data from the feeder registries to examine the long-term safety and effectiveness profile of Tocilizumab (TCZ) in patients with Polyarticular juvenile idiopathic arthritis (pJIA) in an observational setting.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual: 03/11/2014

Study start date

Planned: 14/08/2015

Actual: 15/06/2015

Data analysis start date

Planned: 27/06/2025

Date of final study report

Planned: 31/01/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche

Study protocol

Initial protocol

Prot WA29358 (pJIA Registry) tocilizumab_Redacted

Updated protocol

Prot WA29358 (pJIA Registry) tocilizumab v6, Published Output-1_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)

Other study registration identification numbers and links

WA29358