Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01835470
First received: April 17, 2013
Last updated: September 3, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: Abatacept
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • American College of Rheumatology (ACR) Pediatric 30 response rate [ Time Frame: Week 16 (Day 113) ] [ Designated as safety issue: No ]

    ACR pediatric 30 response is 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



Secondary Outcome Measures:
  • ACR pediatric 50 and 70 response rates [ Time Frame: Week 16 (Day 113) ] [ Designated as safety issue: No ]
  • Disability index of the Childhood Health Assessment Questionnaire (CHAQ) [ Time Frame: Week 16 (Day 113) ] [ Designated as safety issue: No ]
  • Safety summarized by proportion of subjects with Adverse Events (AEs), deaths, Serious Adverse Events (SAEs), and AEs of special interest [ Time Frame: Up to Week 16 (Day 113) - Short term (ST) period ] [ Designated as safety issue: Yes ]
  • Maximum observed concentration (Cmax) of Abatacept [ Time Frame: 9 time points up to Week 16 (Day 113) - ST period ] [ Designated as safety issue: No ]
    Pharmacokinetics summary statistics (geometric mean and coefficient of variation) will be presented for Cmax

  • Trough observed concentration (Ctrough) of Abatacept [ Time Frame: 9 time points up to Week 16 (Day 113) - ST period ] [ Designated as safety issue: No ]
    Pharmacokinetics summary statistics (geometric mean and coefficient of variation) will be presented for Ctrough

  • Immunogenicity positive rates [ Time Frame: Up to Week 16 (Day 113) - ST period ] [ Designated as safety issue: No ]

    Assessment of positive response is determined based on an assay cutpoint value. For the electrochemiluminescence (ECL) assay, for all summaries and listings unless specified otherwise, a positive immunogenicity response for 'Cytotoxic T-lymphocyte antigen (CTLA4) and possibly Immunoglobulin (Ig)', 'Ig and/or Junction Region', respectively, is defined as:

    1. A missing baseline immunogenicity measurement and a positive analytical laboratory reported immunogenicity response post-baseline
    2. A negative baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline
    3. A positive baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline that has a titer value strictly greater than the baseline titer value


Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abatacept
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
Other Names:
  • BMS-188667
  • ONO-4164

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835470

Locations
Japan
Local Institution
Oobu-shi, Aichi, Japan, 4748710
Local Institution
Sapporo-shi, Hokkaido, Japan, 0048618
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution
Kobe-shi, Hyogo, Japan, 6540081
Local Institution
Kagoshima-shi, Kagoshima, Japan, 8900075
Local Institution
Yokohama-shi, Kanagawa, Japan, 2328555
Local Institution
Yokohama-shi, Kanagawa, Japan, 2360004
Local Institution
Sendai-shi, Miyagi, Japan, 9893126
Local Institution
Niigata-shi, Niigata, Japan, 9518520
Local Institution
Nakagami-gun, Okinawa, Japan, 9030215
Local Institution
Takatsuki-shi, Osaka, Japan, 5698686
Local Institution
Bunkyo-ku, Tokyo, Japan, 1138603
Local Institution
Shinjuku-ku, Tokyo, Japan, 1620054
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01835470     History of Changes
Other Study ID Numbers: IM101-365
Study First Received: April 17, 2013
Last Updated: September 3, 2015
Health Authority: Japan: Institutional Review Board
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abatacept
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015