PHARMACOKINETICS, EFFICACY AND SAFETY OF ABATACEPT ADMINISTERED SUBCUTANEOUSLY (SC) IN CHILDREN AND ADOLESCENTS WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA) AND INADEQUATE RESPONSE (IR) TO BIOLOGIC OR NON BIOLOGIC DISEASE MODIFYING ANTI-RHEUMATIC DRUGS (DMARDS)

A PHASE 3 MULTI-CENTER, OPEN-LABEL STUDY TO EVALUATE PHARMACOKINETICS, EFFICACY AND SAFETY OF ABATACEPT ADMINISTERED SUBCUTANEOUSLY (SC) IN CHILDREN AND ADOLESCENTS WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA) AND INADEQUATE RESPONSE (IR) TO BIOLOGIC OR NON BIOLOGIC DISEASE MODIFYING ANTI-RHEUMATIC DRUGS (DMARDS)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-065-13

Enrollment

Registered

2014-02-17

Start date

2013-10-23

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Abatacept SC injection, 1 mL/prefilled syringe, 125 mg/prefilled syringe (125 mg/mL)

1 injection SC/week

24 months

patients 2-17 year old with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) Abatacept SC injection, 0.7 mL/prefilled syringe, 87.5 mg/prefilled syringe (125 mg/mL)

patients 2-17 year old with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) Abatacept SC injection, 0.4 mL/prefilled syringe, 50 mg/prefilled syringe (125 mg/mL)

patients 2-17 year old with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Eligibility

Age

6 Years to 17 Years

Inclusion criteria

Inclusion criteria: pJIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one biologic or non biologic DMARD for at least 3 months prior to screening. Subjects with TNFα inadequate response or other prior biologics 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

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 more than two TNFα antagonists or other biological DMARDS will be excluded.

Countries

Argentina, Belgium, Brazil, France, Germany, Italy, Mexico, Peru, Russian Federation, South Africa, Spain, United States

Contacts

Public ContactLarissa Silva

BRISTOL MYERS SQUIBB PERU S.A.

larissa.silva@bms.com411-6200

Outcome results