MedTrace Logo

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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2023-07-12

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Active Polyarticular Juvenile Idiopathic Arthritis

Interventions

BIOLOGICAL

Abatacept

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-30
Primary Completion
2015-03-12
Completion
2023-02-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • France
  • Germany
  • Italy
  • Mexico
  • Peru
  • Russia
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01844518 on ClinicalTrials.gov