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An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis


N/A
N/A
17 Years
Open (Enrolling)
Both
Juvenile Idiopathic Arthritis

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Trial Information

An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis


Inclusion Criteria:



- Diagnosis of JIA (any subtype).

- Age < 18 years at the time of enrollment.

- Receiving Abatacept at the time of enrollment as per treating physician's decision.

- 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).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Incidence rate of serious infections

Outcome Time Frame:

10 years

Safety Issue:

Yes

Principal Investigator

Bristol-Mayers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Mayers Squibb

Authority:

United States: Institutional Review Board

Study ID:

IM101-240

NCT ID:

NCT01357668

Start Date:

January 2013

Completion Date:

June 2028

Related Keywords:

  • Juvenile Idiopathic Arthritis
  • Arthritis
  • Arthritis, Juvenile Rheumatoid

Name

Location

Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039