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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Bristol-Myers Squibb
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: May 27, 2014
Last verified: September 2013
  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: December 2018 (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

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
Japan
Local Institution Recruiting
Oobu-shi, Aichi, Japan, 4748710
Contact: Site 0004         
Local Institution Recruiting
Sapporo-shi, Hokkaido, Japan, 0048618
Contact: Site 0011         
Local Institution Recruiting
Kobe-shi, Hyogo, Japan, 6540081
Contact: Site 0005         
Local Institution Recruiting
Kagoshima-shi, Kagoshima, Japan, 8900075
Contact: Site 0002         
Local Institution Recruiting
Yokohama-shi, Kanagawa, Japan, 2360004
Contact: Site 0001         
Local Institution Recruiting
Sendai-shi, Miyagi, Japan, 9893126
Contact: Site 0003         
Local Institution Recruiting
Niigata-shi, Niigata, Japan, 9518520
Contact: Site 0010         
Local Institution Recruiting
Takatsuki-shi, Osaka, Japan, 5698686
Contact: Site 0008         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1138603
Contact: Site 0007         
Local Institution Recruiting
Shinjuku-ku, Tokyo, Japan, 1620054
Contact: Site 0006         
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: May 27, 2014
Health Authority: Japan: Institutional Review Board
Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on July 22, 2014