Safety Study of Abatacept in Sweden

A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Sweden Using the ARTIS Register

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01094795

Enrollment

92635

Registered

2010-03-29

Start date

2011-03-31

Completion date

2019-06-24

Last updated

2022-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

The primary purpose of this study is to assess incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Resident of Sweden

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Hospitalized infection	Every 6 months throughout the study
Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer)	Every 6 months throughout the study
Total mortality	Every 6 months throughout the study

Secondary

Measure	Time frame
Autoimmune disorders (lupus, psoriasis, multiple sclerosis)	Every 6 months throughout the study

Outcome results