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BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00095173
First received: November 1, 2004
Last updated: November 22, 2016
Last verified: November 2016
Results First Received: September 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Juvenile Rheumatoid Arthritis
Interventions: Drug: Abatacept
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
214 enrolled; in Per A, 190 treated; 24 not treated due to screening failures.170 completed Per A, 123 responders qualified to enter Per B. One subject did not enter Per B; 122 responders were randomized, 60 abatacept and 62 placebo. 36 of 47 Per A non-responders re-entered at Per C. Protocol violation occurred; 5yr old participant.

Reporting Groups
  Description
Abatacept (All Participants in Period A) Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
Abatacept (Period B) Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare (Period B).
Placebo (Period B) Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
Abatacept (Period A Non-Responders in Period C) Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) or once a month for up to 5 years (Period C).
Abatacept (Period C) Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
Placebo (Period B) to Abatacept (Period C) Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.

Participant Flow for 3 periods

Period 1:   Open-Label Lead-In Phase (Period A)
    Abatacept (All Participants in Period A)   Abatacept (Period B)   Placebo (Period B)   Abatacept (Period A Non-Responders in Period C)   Abatacept (Period C)   Placebo (Period B) to Abatacept (Period C)
STARTED   190   0   0   0   0   0 
COMPLETED   170   0   0   0   0   0 
NOT COMPLETED   20   0   0   0   0   0 
Adverse Event                1                0                0                0                0                0 
Lack of Efficacy                17                0                0                0                0                0 
Withdrawal by Subject                1                0                0                0                0                0 
Not specified                1                0                0                0                0                0 

Period 2:   Double-Blind Phase (Period B)
    Abatacept (All Participants in Period A)   Abatacept (Period B)   Placebo (Period B)   Abatacept (Period A Non-Responders in Period C)   Abatacept (Period C)   Placebo (Period B) to Abatacept (Period C)
STARTED   0 [1]   60 [2]   62 [2]   0   0   0 
COMPLETED   0   49   31   0   0   0 
NOT COMPLETED   0   11   31   0   0   0 
Lack of Efficacy                0                10                31                0                0                0 
Withdrawal by Subject                0                1                0                0                0                0 
[1] All participants did not continue; responders entered Period B; non-responders re-entered Period C.
[2] 123 responders from Period A qualified;122 entered and were randomized to abatacept and placebo.

Period 3:   Open-Label Extension Phase (Period C)
    Abatacept (All Participants in Period A)   Abatacept (Period B)   Placebo (Period B)   Abatacept (Period A Non-Responders in Period C)   Abatacept (Period C)   Placebo (Period B) to Abatacept (Period C)
STARTED   0   0   0   36 [1]   58 [2]   59 [3] 
COMPLETED   0   0   0   13   29   27 
NOT COMPLETED   0   0   0   23   29   32 
Death                0                0                0                0                0                1 
Adverse Event                0                0                0                1                2                3 
Lack of Efficacy                0                0                0                11                5                8 
Lost to Follow-up                0                0                0                2                5                6 
Withdrawal by Subject                0                0                0                4                6                0 
No Longer Meets Study Criteria                0                0                0                0                1                1 
Poor/Non-Compliance                0                0                0                0                2                2 
Pregnancy                0                0                0                1                2                3 
Not Specified                0                0                0                4                6                8 
[1] Participants were non-responders from Period A who re-entered in Period C.
[2] Includes 47 who completed Period B with no flare and 11 who discontinued Period B due to a flare
[3] Includes 33 who discontinued Period B due to a flare and 26 who completed Period B with no flare



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated participants in the Lead-In Phase (Period A)

Reporting Groups
  Description
Abatacept (All Participants in Period A) Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes,once every 2 weeks for 3 doses, then monthly up to 6 months unless a disease flare discontinued the patient earlier.

Baseline Measures
   Abatacept (All Participants in Period A) 
Overall Participants Analyzed 
[Units: Participants]
 190 
Age 
[Units: Years]
Median (Full Range)
 13.0 
 (5.0 to 17.0) 
Gender 
[Units: Participants]
Count of Participants
 
Female      137  72.1% 
Male      53  27.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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) ]

3.  Secondary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]

6.  Secondary:   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) ]

7.  Secondary:   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) ]

8.  Secondary:   Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies   [ Time Frame: Period A (Day 1 to Day 113) ]

9.  Secondary:   Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies   [ Time Frame: Period B (Day 113 to Day 282) ]

10.  Secondary:   Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies   [ Time Frame: Period C (Day 282 up to 56 days after the last dose of study medication) ]

11.  Secondary:   Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate   [ Time Frame: Day 113, Day 282, and Day 2047 ]

12.  Secondary:   Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)   [ Time Frame: Period A (Day 1 to Day 113) ]

13.  Secondary:   Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)   [ Time Frame: Period B (Day 113 to Day 282) ]

14.  Secondary:   Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)   [ Time Frame: Period C (Day 282 to end of study) ]

15.  Secondary:   Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)   [ Time Frame: Period C (Day 282 to 85 days after the last dose of study medication) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00095173     History of Changes
Other Study ID Numbers: IM101-033
Study First Received: November 1, 2004
Results First Received: September 22, 2016
Last Updated: November 22, 2016