Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Observational safety and effectiveness study as post-marketing commitment to FDA and EMA

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

ROACTEMRA

Study drug International non-proprietary name (INN) or common name

TOCILIZUMAB

Anatomical Therapeutic Chemical (ATC) code

(L04AC07) tocilizumab
tocilizumab

Medical condition to be studied

Juvenile idiopathic arthritis

Additional medical condition(s)

Polyarticular juvenile idiopathic arthritis
Population studied

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)

Estimated number of subjects

600
Study design details

Main study objective

To assess the long-term safety and effectiveness of TCZ in relation to comparator biologics in the treatment of pJIA in a real-world setting for 5 years.

Outcomes

- Rate of serious adverse events
- Rates of serious adverse events in the following categories of special interest: * Infections * Cardiovascular events * Malignancies * Gastrointestinal perforations
- Rate and treatment outcome of uveitis - Growth patterns - Development patterns
- Juvenile Arthritis Disease Activity Score in 10 joints (JADAS-10)

Data analysis plan

Descriptive summary analyses will be used to characterize baseline demographics, medical history, medications, growth and development.
Incidence rates, with 95% confidence intervals, will be provided for serious adverse events. Height standard deviation scores will be summarized descriptively over time by treatment group. The data for development patterns will be summarized by gender for each treatment group.
The rate of uveitis and description of treatment outcome will be summarized. JADAS-10 will be summarized over time.