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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

NCT01844518•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

2 - 17 years

Sex

ALL

Healthy Volunteers

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)

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

Key Dates

Start Date

August 30, 2013

Primary Completion Date

March 12, 2015

Completion Date

February 1, 2023

Last Updated

July 12, 2023

Enrollment

219

ACTUAL participants

Conditions

Active Polyarticular Juvenile Idiopathic Arthritis

Interventions

Abatacept

BIOLOGICAL