Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Prospective observational cohort study
Study drug and medical condition

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

ADALIMUMAB

Medical condition to be studied

Rheumatoid arthritis
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Hepatic impaired
Immunocompromised
Pregnant women
Renal impaired

Estimated number of subjects

300
Study design details

Main study objective

The primary objective of this study is to estimate the incidence rates of the following safety concerns (identified risks of adalimumab) in patients with RA exposed to AMGEVITA: serious infections (ie, infectious events which require IV antibiotics, hospitalization, or meet other criteria for a serious adverse event)

Outcomes

The primary outcome measures are: Incidence of serious infections (ie, infectious events which require IV antibiotics, hospitalization, or meet other criteria for a serious adverse event) in patients with RA exposed to AMGEVITA, The secondary outcome measures are: • Incidence of serious hypersensitivity reactions in patients with RA exposed to AMGEVITA • incidence of other serious adverse events (safety concerns) in patients with RA exposed to AMGEVITA• incidence rates safety concerns from both the BSRBR-RA anti-TNFand nbDMARD comparison cohorts.

Data analysis plan

All analyses will be descriptive. For categorical variables, the frequency and percentage, with 95% CI where appropriate, will be provided. Summary statistics for continuous variables will include the number of patients, mean, median, SD or standard error, minimum and maximum. Follow-up among the AMGEVITA-treated patients will start from initiation of the drug and end with the occurrence of death, discontinuation of AMGEVITA or the end of the 5-year follow-up period, whichever comes first. For the purposes of context, current incidence rates will also be calculated from both of the following BSRBR-RA comparison cohorts: anti-TNF comparison cohort, which is a cohort of patients receiving an established anti-TNF drug (adalimumab, etanercept or infliximab) who were recruited within 6 months of first exposure. nbDMARD comparison cohort, which is a cohort of patients with similar disease activity receiving conventional systemic DMARDs who have never been exposed to biologic therapy