Juvenile Idiopathic Arthritis
Conditions
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of serious infections | 10 years |
| Incidence rate of malignancies | 10 years |
| Incidence rate of autoimmune disorders | 10 years |
Secondary
| Measure | 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 |
Countries
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, United States
Outcome results
None listed