An Observational Registry of Abatacept in Patients With J... | NCT01357668

Studies
An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

NCT01357668

Sponsor

Bristol-Myers Squibb

Status

Active, not recruiting

Last Update Posted

Sep 25, 2025Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Juvenile Idiopathic Arthritis

Interventions

Not provided

Countries

United States
Austria
Brazil
Canada
Denmark
France
Germany
Greece
Hungary
Israel
Italy
Latvia
Mexico
Netherlands
Norway
Peru
Portugal
Puerto Rico
Romania
Russia
Saudi Arabia
Slovakia
South Africa
Spain
United Kingdom

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

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2013Actual

Primary Completion Date

Jan 2, 2029Estimated

Completion Date

Jan 2, 2029Estimated

First Submitted Date

May 19, 2011

First Submission Date that Met QC Criteria

May 20, 2011

First Posted Date

May 23, 2011Estimated

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

Sep 24, 2025

Last Update Posted Date

Sep 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.

Detailed Description

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

Retention

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with JIA who are treated with Abatacept		Patients with JIA who are treated with Abatacept according to physicians'/families' decisions

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence rate of serious infections		10 years
Incidence rate of malignancies		10 years
Incidence rate of autoimmune disorders		10 years

Secondary Outcomes

Measure	Description	Time Frame
Number of serious adverse events		10 years
Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections)		10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria

Diagnosis of JIA (any subtype)
Age < 18 years at the time of enrollment unless currently or previously enrolled in an abatacept clinical trial and received abatacept
Receiving Abatacept at the time of enrollment as per treating physician's decision or received abatacept in a clinical trial
Parent or legally acceptable representative willing to participate in the study and sign the informed consent

Exclusion Criteria

Pregnant or nursing female at the time of enrollment
Prior malignancies if the patient has not been malignancy free for at least 5 years.
Any serious acute or chronic medical condition other than JIA, including chronic infection, which would compromise the patient's ability to participate in the study
Known poor compliance with clinic visits (based on physician judgment).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Pediatric rheumatology clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0060		Little Rock	Arkansas	72202	United States
Local Institution - 0001

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38243722	Derived	Lovell DJ, Tzaribachev N, Henrickson M, Simonini G, Griffin TA, Alexeeva E, Bohnsack JF, Zeft A, Horneff G, Vehe RK, Stanevica V, Tarvin S, Trachana M, Del Rio AQ, Huber AM, Kietz D, Orban I, Dare J, Foeldvari I, Quartier P, Dominique A, Simon TA, Martini A, Brunner HI, Ruperto N; for PRINTO and the Pediatric Rheumatology Collaborative Study Group (PRCSG) section sign. Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry. Rheumatology (Oxford). 2024 Sep 1;63(SI2):SI195-SI206. doi: 10.1093/rheumatology/keae025.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases