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Phase IIIB Switching From Intravenous to Subcutaneous Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00663702
First received: April 18, 2008
Last updated: February 22, 2012
Last verified: February 2012
Results First Received: January 19, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Intervention: Drug: Abatacept

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 3 locations and 32 sites worldwide: United States (20 sites), Canada (6 sites), and Mexico (6 sites).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 126 participants were enrolled, and 3 discontinued prior to study start due to failure to continue to meet study eligibility criteria.

Reporting Groups
  Description
Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure) Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure) Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Participant Flow for 2 periods

Period 1:   Days 1 to 85
    Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)     Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)  
STARTED     52     71  
COMPLETED     49     71  
NOT COMPLETED     3     0  
Adverse Event                 1                 0  
Withdrawal by Subject                 1                 0  
Lost to Follow-up                 1                 0  

Period 2:   Cumulative Period (Day 1 to Month 20)
    Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)     Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)  
STARTED     52 [1]   71 [1]
COMPLETED     43     69  
NOT COMPLETED     9     2  
Adverse Event                 3                 1  
Participant Withdrew Consent                 3                 0  
Lack of Efficacy                 2                 1  
Lost to Follow-up                 1                 0  
[1] Because Cumulative Phase includes Days 1 to 85, this number includes all participants from Day 1.



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure) Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or BMS IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure) Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Total Total of all reporting groups

Baseline Measures
    Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)     Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)     Total  
Number of Participants  
[units: participants]
  52     71     123  
Age  
[units: Years]
Mean ± Standard Deviation
  56.5  ± 10.2     52.8  ± 13.8     54.3  ± 12.5  
Gender  
[units: Participants]
     
Female     42     59     101  
Male     10     12     22  
Race/Ethnicity, Customized  
[units: Partcipants]
     
White     47     70     117  
Black/African American     3     0     3  
American Indian/Alaska Native     1     0     1  
Asian     0     1     1  
Other     1     0     1  
Region of Enrollment  
[units: Participants]
     
North America     52     16     68  
South America     0     55     55  
Mean Baseline High Sensitivity C-Reactive Protein Level  
[units: μg/mL]
Mean ± Standard Deviation
  0.94  ± 0.65     0.92  ± 0.88     0.93  ± 0.79  
Mean Baseline 28 Joint Disease Activity Score (DAS 28) [1]
[units: Score on a scale]
Mean ± Standard Deviation
  3.55  ± 1.20     3.28  ± 1.29     3.39  ± 1.26  
Mean Number of Tender Joints at Baseline  
[units: Joints]
Mean ± Standard Deviation
  9.1  ± 12.8     8.8  ± 12.4     8.9  ± 12.5  
Mean Number of Swollen Joints at Baseline  
[units: Joints]
Mean ± Standard Deviation
  5.4  ± 6.4     4.3  ± 5.9     4.8  ± 6.1  
Participant Weight at Baseline  
[units: Participants]
     
Less than 60 kilograms     9     14     23  
60-100 kilograms     30     54     84  
Greater than 100 kilograms     10     3     13  
Missing     3     0     3  
[1] The DAS 28 is a 28-item joint disease activity score used to quantify disease expression and progression in rheumatoid arthritis. Severity is indicated with increasing item score on the scale with 0=no joints affected and 28=all joints affected.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs), Treatment-related AEs, Discontinuations Due to AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, and Death As Outcome Through Day 85   [ Time Frame: Days 1 through 85 ]

2.  Primary:   Number of Participants With AEs of Special Interest Through Day 85   [ Time Frame: Days 1 through 85 ]

3.  Primary:   Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality Through Day 85   [ Time Frame: Days 1 through 85 ]

4.  Primary:   Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality Through Day 85   [ Time Frame: Days 1 through 85 ]

5.  Primary:   Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality Through Day 85   [ Time Frame: Days 1 through 85 ]

6.  Primary:   Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality Through Day 85   [ Time Frame: Days 1 through 85 ]

7.  Primary:   Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality Through Day 85   [ Time Frame: Days 1 through 85 ]

8.  Primary:   Mean Sitting Systolic and Diastolic Blood Pressure (BP) Through Day 85   [ Time Frame: Before injection on Days 1, 29, 57, and 85 ]

9.  Primary:   Mean Heart Rate Through Day 85   [ Time Frame: Before injection on Days 1, 26, 57, and 85 ]

10.  Primary:   Mean Temperature Through Day 85   [ Time Frame: Before injection on Days 1, 29, 57, and 85 ]

11.  Secondary:   Mean Trough Serum Concentration (Cmin) of Abatacept Through Day 85   [ Time Frame: Days 29, 85, 57, and 85 ]

12.  Secondary:   Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) Through Day 85   [ Time Frame: Days 1 through 85 ]

13.  Secondary:   Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) Through Day 85   [ Time Frame: Days 1 through 85 ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00663702     History of Changes
Other Study ID Numbers: IM101-185
Study First Received: April 18, 2008
Results First Received: January 19, 2012
Last Updated: February 22, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: National Institute of Public Health, Health Secretariat