NCT01835470

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

August 9, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 11, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

2.3 years

First QC Date

April 17, 2013

Results QC Date

November 15, 2016

Last Update Submit

February 24, 2021

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16

    American College of Rheumatology (ACR) pediatric (PED) 30 response was defined as '≥30% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. JIA core set variables defined as the number of active joints, number of joints with Limit of Motion (LOM), physician's global assessment of disease severity, patient global assessment of overall well being, parent assessment of physical function, and acute phase reactant value. A non-responder imputation was applied.

    Week 16 (Day 113)

Secondary Outcomes (6)

  • Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16

    Week 16 (Day 113)

  • Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16

    Week 16 (Day 113)

  • 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

    Day 1 up to 56 days post Week 16 (Day 113); approximately 6 months

  • Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period

    9 time points up to Week 16 (Day 113)

  • Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period

    9 time points up to Week 16 (Day 113)

  • +1 more secondary outcomes

Study Arms (1)

Abatacept

EXPERIMENTAL

Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study

Drug: Abatacept

Interventions

AbataceptDRUG
Also known as: BMS-188667, ONO-4164
Abatacept

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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:
  • ≥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 joints with LOM at screening and at Week 0 (Day 1).

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Local Institution

Oobu-shi, Aichi-ken, 4748710, Japan

Location

Local Institution

Sapporo, Hokkaido, 0048618, Japan

Location

Local Institution

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution

Kobe, Hyōgo, 6500047, Japan

Location

Local Institution

Kagoshima, Kagoshima-ken, 8908520, Japan

Location

Local Institution

Yokohama, Kanagawa, 2328555, Japan

Location

Local Institution

Yokohama, Kanagawa, 2360004, Japan

Location

Local Institution

Sendai, Miyagi, 9893126, Japan

Location

Local Institution

Niigata, Niigata, 9518520, Japan

Location

Local Institution

Nakagami-gun, Okinawa, 9030215, Japan

Location

Local Institution

Takatsuki-shi, Osaka, 5698686, Japan

Location

Local Institution

Bunkyo-ku, Tokyo, 1138603, Japan

Location

Local Institution

Shinjuku-ku, Tokyo, 1620054, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31039807DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Abatacept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 19, 2013

Study Start

August 9, 2013

Primary Completion

November 24, 2015

Study Completion

July 30, 2018

Last Updated

February 26, 2021

Results First Posted

January 11, 2017

Record last verified: 2021-02

Locations

JP(13)