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)

Bristol-Myers Squibb219 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

219

Conditions

Active Polyarticular Juvenile Idiopathic Arthritis

Interventions

AbataceptBIOLOGICAL

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (57)

Outcomes

Primary Outcomes

Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17

Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be \>= 10 µg/mL.

Time frame: Day 113

Secondary Outcomes

Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)

ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables: 1. number of active joints 2. number of joints with limitation of motion (LOM) 3. physician global assessment of disease activity 4. parent global assessment of patient overall well-being 5. functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ) 6. C-reactive protein (CRP). In addition to the above condition, to be considered a responder participants cannot have ≥30% worsening in more than 1 of the 3 remaining JIA core set variables for which improvement was not observed.

Time frame: Day 113

Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose

Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable participants at Days 57, 85 and 113. Weight-tiered dosing groups are based on the first dose the participant received. Cmin is reported in microgram per milliliter (µg/mL). Here 'n' number analyzed signifies participants who were evaluable for each time point.

Time frame: Days 57, 85 and 113

Number of Participants With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short-Term Period for the 6-17 Year Age-Group Cohort

An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which results in death, is life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.

Data from ClinicalTrials.gov

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Local Institution - 0007

Birmingham, Alabama, United States

Local Institution - 0003

Little Rock, Arkansas, United States

Local Institution - 0011

Hartford, Connecticut, United States

Local Institution - 0009

Chicago, Illinois, United States

Riley Hospital For Children

Indianapolis, Indiana, United States

University Of Kansas Medical Center

Kansas City, Kansas, United States

Local Institution - 0001

Kansas City, Missouri, United States

Local Institution - 0002

The Bronx, New York, United States

Local Institution - 0008

Cincinnati, Ohio, United States

Local Institution - 0005

Portland, Oregon, United States

...and 47 more locations

Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period

Time frame: From first dose up to 56 days after last dose ( up to approximately 2 years)