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)

Phase 1

• Conditions: Active Polyarticular Juvenile Idiopathic Arthritis (pJIA); MedDRA version: 14.1Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-003195-39-IT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-22
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. 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 TNFa antagonists for at least 3 months prior to screening

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

3. 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 210
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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 TNFa antagonists or other biological DMARDS will be excluded.

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

3. Subjects who have failed more than two TNFa antagonists or other biologic DMARDs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified