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

Supplemental Data for the Juvenile Idiopathic Arthritis FDA Written Request

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03769558

Enrollment

264

Registered

2018-12-07

Start date

2016-07-12

Completion date

2016-09-30

Last updated

2020-03-20

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

Conditions

Juvenile Idiopathic Arthritis

Brief summary

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

Interventions

OTHERNon-Interventional

Non-Interventional

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Months to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of infections	110 months

Secondary

Measure	Time frame
Incidence of malignancies	110 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026