NCT03769558

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

December 6, 2018

Last Update Submit

March 19, 2020

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Incidence of infections

    110 months

Secondary Outcomes (1)

  • Incidence of malignancies

    110 months

Study Arms (1)

JIA patients prescribed abatacept

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

JIA patients prescribed abatacept

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will include all patients with JIA who are treated with abatacept

You may qualify if:

  • 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

You may not qualify if:

  • Greater than or equal to 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Princeton, New Jersey, 08540, United States

Location

Related Links

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 7, 2018

Study Start

July 12, 2016

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

US(1)