Safety Study of Abatacept in Sweden

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.

Completed

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Resident of Sweden

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Hospitalized infection

Time frame: Every 6 months throughout the study
Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer)

Time frame: Every 6 months throughout the study
Total mortality

Time frame: Every 6 months throughout the study

Secondary outcomes

Autoimmune disorders (lupus, psoriasis, multiple sclerosis)

Time frame: Every 6 months throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

Karolinska Institutet

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2019
Study completion: 2019
First posted: Mar 29, 2010
Registry last updated: Jun 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed