A Study of Juvenile Idiopathic Arthritis Patients Given Abatacept and the Number of Infections or Malignancies That Occur

This study will determine the incidences of infections and malignancies among JIA patients treated with abatacept

Completed

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Key information

Conditions

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

Age range

12 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Two diagnoses of JIA (ICD-9 code 714.3x) within 90 days
Age less than 18 years at the time of second of the two diagnoses
Index date is the date of initiating treatment with abatacept

Exclusion criteria

Greater than or equal to 18 years of age

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

Incidence of infections

Time frame: 110 months

Secondary outcomes

Incidence of malignancies

Time frame: 110 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Supplemental Data for the Juvenile Idiopathic Arthritis FDA Written Request

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Dec 7, 2018
Registry last updated: Mar 20, 2020

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