Clinical Trial: BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juv

Brief Summary: The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.

Detailed Summary:
Sponsor: Bristol-Myers Squibb

Current Primary Outcome: Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B) [ Time Frame: Period B (Day 113 to Day 282) ]

Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed.

All of the following criteria must be met to be defined as a flare:

  • > 30% worsening in at least 3 of the 6 JRA/JIA core response variables
  • > 30% improvement in not more than 1 of the 6 JRA/JIA core set variables
  • ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare
  • worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)


Original Primary Outcome:

Current Secondary Outcome:

  • Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B) [ Time Frame: Period B (Day 113 to Day 282) ]

    All of the following criteria must be met to be defined as a flare:

    • > 30% worsening in at least 3 of the 6 JRA/JIA core response variables
    • > 30% improvement in not more than 1 of the 6 JRA/JIA core set variables
    • ≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare
    • worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)
  • Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A) [ Time Frame: Period A (Day 1 to Day 113) ]

    AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.

    SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).

  • Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B) [ Time Frame: Period B (Day 113 to Day 282) ]

    AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.

    SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).

  • Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C) [ Time Frame: Period C (Day 282 to end of study) ]
    AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 85 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).
  • Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B) [ Time Frame: Period B (Day 113 to Day 282) ]
    Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.
  • Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C) [ Time Frame: Period C (Day 282 to end of study) ]
    Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician's global

    Original Secondary Outcome:

    Information By: Bristol-Myers Squibb

    Dates:
    Date Received: November 1, 2004
    Date Started: December 2003
    Date Completion:
    Last Updated: November 22, 2016
    Last Verified: November 2016