A Study of Juvenile Idiopathic Arthritis Patients Given A... | NCT03769558

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

NCT03769558

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Mar 20, 2020Actual

Enrollment

264Actual

Phase

Not provided

Conditions

Juvenile Idiopathic Arthritis

Interventions

Non-Interventional

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 12, 2016Actual

Primary Completion Date

Sep 30, 2016Actual

Completion Date

Sep 30, 2016Actual

First Submitted Date

Dec 6, 2018

First Submission Date that Met QC Criteria

Dec 6, 2018

First Posted Date

Dec 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2020

Last Update Posted Date

Mar 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

264Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JIA patients prescribed abatacept			Other: Non-Interventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional	Other	Non-Interventional	JIA patients prescribed abatacept

Measure	Description	Time Frame
Incidence of infections		110 months

Measure	Description	Time Frame
Incidence of malignancies		110 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Princeton	New Jersey	08540	United States

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
Investigator Inquiry Form	View source
FDA Safety Alerts and Recalls

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases