An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Juvenile Idiopathic Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01357668

IM101-240

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and 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 design

800 participants in 1 patient group

Patients with JIA who are treated with Abatacept

Description:

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