An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A - 17 Years
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01357668
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, Brazil, Canada, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Mexico, Netherlands, Peru, Portugal, Puerto Rico, Romania, Russian Federation, Slovakia, South Africa, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Juvenile Idiopathic Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

: Patients with JIA who are treated with Abatacept

Patients with JIA who are treated with Abatacept according to physicians'/families' decisions

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bristol-Myers Squibb, Active, Princeton, New Jersey

Status

Recruiting

Address

Bristol-Myers Squibb, Active

Princeton, New Jersey, 08540

Site Contact

Mr Bristol-Myers Squibb, Site 0001

[email protected]

855-907-3286

International Sites

Local Institution, Innsbruck, Austria

Status

Recruiting

Address

Local Institution

Innsbruck, , A-6020

Site Contact

Site 0002

[email protected]

855-907-3286

Local Institution, Botucatu, Sao Paulo, Brazil

Status

Recruiting

Address

Local Institution

Botucatu, Sao Paulo, 18618-970

Site Contact

Site 0010

[email protected]

855-907-3286

Local Institution, Montreal, Quebec, Canada

Status

Recruiting

Address

Local Institution

Montreal, Quebec, H4A 3J1

Site Contact

Site 0011

[email protected]

855-907-3286

Local Institution, Copenhagen, Denmark

Status

Recruiting

Address

Local Institution

Copenhagen, , 2100

Site Contact

Site 0012

[email protected]

855-907-3286

Local Institution, Paris Cedex 15, France

Status

Recruiting

Address

Local Institution

Paris Cedex 15, , 75743

Site Contact

Site 0005

[email protected]

855-907-3286

Local Institution, Bad Bramstedt, Germany

Status

Recruiting

Address

Local Institution

Bad Bramstedt, , 24576

Site Contact

Site 0003

[email protected]

855-907-3286

Local Institution, Thessaloniki, Greece

Status

Recruiting

Address

Local Institution

Thessaloniki, , 54642

Site Contact

Site 0016

[email protected]

855-907-3286

Local Institution, Budapest, Hungary

Status

Recruiting

Address

Local Institution

Budapest, , H-1023

Site Contact

Site 0017

[email protected]

855-907-3286

Local Institution, Jerusalem, Israel

Status

Completed

Address

Local Institution

Jerusalem, , 91031

Local Institution, Genova, Italy

Status

Recruiting

Address

Local Institution

Genova, , 16147

Site Contact

Site 0015

[email protected]

855-907-3286

Local Institution, Riga, Latvia

Status

Recruiting

Address

Local Institution

Riga, , LV-1007

Site Contact

Site 0018

[email protected]

855-907-3286

Local Institution, Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

Local Institution

Guadalajara, Jalisco, 44620

Site Contact

Site 0006

[email protected]

855-907-3286

Local Institution, Utrecht, Netherlands

Status

Recruiting

Address

Local Institution

Utrecht, , 3584 EA

Site Contact

Site 0019

[email protected]

855-907-3286

Local Institution, Lima, Peru

Status

Recruiting

Address

Local Institution

Lima, , 1

Site Contact

Site 0007

[email protected]

855-907-3286

Local Institution, Lisboa, Portugal

Status

Recruiting

Address

Local Institution

Lisboa, , 1600

Site Contact

Site 0020

[email protected]

855-907-3286

Bayamon, Puerto Rico

Status

Completed

Address

Centro de Reumatologia Pediatrico de Puerto Rico

Bayamon, , PR 960

Local Institution, Cluj-Napoca, Romania

Status

Recruiting

Address

Local Institution

Cluj-Napoca, ,

Site Contact

Site 0021

[email protected]

855-907-3286

Local Institution, Moscow, Russian Federation

Status

Active, not recruiting

Address

Local Institution

Moscow, , 119991

Local Institution, Piestany, Slovakia

Status

Recruiting

Address

Local Institution

Piestany, ,

Site Contact

Site 0022

[email protected]

855-907-3286

Local Institution, Pretoria, Gauteng, South Africa

Status

Recruiting

Address

Local Institution

Pretoria, Gauteng, 0002

Site Contact

Site 0009

[email protected]

855-907-3286

Local Institution, Barcelona, Spain

Status

Recruiting

Address

Local Institution

Barcelona, , 08035

Site Contact

Site 0004

[email protected]

855-907-3286

Local Institution, Bristol, United Kingdom

Status

Completed

Address

Local Institution

Bristol, , BS2 8BJ