Abatacept administered subcutaneously in children and adolescents with polyarticular JIA

Trial

Clinical Trial Title

Abatacept administered subcutaneously in children and adolescents with polyarticular JIA

Trial Status

Open to Enrollment

Start Date

August 1, 2013

Trial Type

Pediatric Rheumatology

Specific Condition

JIA

Description

The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA.

Eligibility Criteria

Ages Eligible for Study:  

2 Years to 17 Years

Genders Eligible for Study:  

Both

Accepts Healthy Volunteers:  

No

Criteria

Inclusion Criteria:

JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one non biologic DMARD or Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening

Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30% of the population

Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ≥2 active joints and ≥2 joints with limitation of motion.

Exclusion Criteria:

Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis, systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more TNFα antagonists or other biological DMARDs will be excluded.

Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization.

Subjects who have failed more than two TNFα antagonists or other biologic DMARDs

IRB Number

10611

Principal Investigator Name

Daniel Kingsbury, MD

Contact Name

Kristiin Hickey

Phone

503-413-5447

Contact E-Mail

khickey@lhs.org

Last Updated: Wednesday, September 18, 2013 01:23:17 PM