Clinical trial NCT01835470: Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan
Official title: A Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or Biologics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2013-04-19
Enrollment: 23
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or intolerance to Methotrexate or biologics


Eligibility criteria: Inclusion Criteria:

* Subjects who have a history of an inadequate therapeutic response or intolerance in the opinion of the examining physician to at least one biologics or Methotrexate (MTX).
* Diagnosis of Juvenile Idiopathic Arthritis (JIA) by International League of Associations for Rheumatology (ILAR) criteria as oligoarticular, polyarticular Rheumatoid Factor (RF+), polyarticular (RF-), or systemic with a polyarticular-course.
* Men and women, ages 4 to 17 years, inclusive at enrollment.
* Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease as defined by:

  1. ≥2 active joints (e.g. presence of swelling, or if no swelling is present, limitation of motion (LOM) accompanied by pain, tenderness, or both) at screening and at Week 0 (Day 1).
  2. ≥2 joints with LOM at screening and at Week 0 (Day 1).

Exclusion Criteria:

* Systemic onset JIA with any of the following manifestations within the last 6 months prior to enrollment: intermittent fever due to JIA, rheumatoid rash, hepatosplenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.
* Presence of any other rheumatic disease or major chronic infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, hypogammaglobulinemia, or systemic lupus erythematosus, etc.)

Primary outcomes:
measure: Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16
timeFrame: Week 16 (Day 113)
Secondary outcomes:
measure: Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16
timeFrame: Week 16 (Day 113)
measure: Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16
timeFrame: Week 16 (Day 113)
measure: Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period
timeFrame: Day 1 up to 56 days post Week 16 (Day 113); approximately 6 months
measure: Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period
timeFrame: 9 time points up to Week 16 (Day 113)
measure: Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period
timeFrame: 9 time points up to Week 16 (Day 113)
measure: Number of Participants With Positive Immunogenicity During the Short Term Period
timeFrame: Day 1 up to Week 16 (Day 113)
Other outcomes:
Locations:
city: Oobu-shi
country: Japan
facility: Local Institution
state: Aichi
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Kobe
country: Japan
facility: Local Institution
state: Hyogo
city: Kagoshima-shi
country: Japan
facility: Local Institution
state: Kagoshima
city: Yokohama-shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Local Institution
state: Miyagi
city: Niigata-shi
country: Japan
facility: Local Institution
state: Niigata
city: Nakagami-gun
country: Japan
facility: Local Institution
state: Okinawa
city: Takatsuki-shi
country: Japan
facility: Local Institution
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Hara R, Umebayashi H, Takei S, Okamoto N, Iwata N, Yamasaki Y, Nakagishi Y, Kizawa T, Kobayashi I, Imagawa T, Kinjo N, Amano N, Takahashi Y, Mori M, Itoh Y, Yokota S. Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study. Pediatr Rheumatol Online J. 2019 Apr 30;17(1):17. doi: 10.1186/s12969-019-0319-4.