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Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01001832
First received: October 26, 2009
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
Results First Received: October 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Intravenous (IV) abatacept
Drug: Subcutaneous (SC) 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 118 participants randomized, all received treatment in the Short-term Period.

Reporting Groups
  Description
Subcutaneous (SC) Abatacept, 125 mg

Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.

Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Intravenous (IV) Abatacept, 125 mg

Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.

Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).

Participant Flow for 2 periods

 Period 1:   Short-term Period
    Subcutaneous (SC) Abatacept, 125 mg     Intravenous (IV) Abatacept, 125 mg  
STARTED     59     59  
COMPLETED     57     56  
NOT COMPLETED     2     3  
Adverse Event                 2                 3  

Period 2:   Long-term Period
    Subcutaneous (SC) Abatacept, 125 mg     Intravenous (IV) Abatacept, 125 mg  
STARTED     56 [1]   56  
COMPLETED     53     51  
NOT COMPLETED     3     5  
Adverse Event                 3                 0  
Lack of Efficacy                 0                 2  
Not specified                 0                 3  
[1] 1 participant discontinued before start of the Long-term Period.



  Baseline Characteristics
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Reporting Groups
  Description
Subcutaneous (SC) Abatacept, 125 mg

Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.

Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Intravenous (IV) Abatacept, 125 mg

Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.

Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).
Total Total of all reporting groups

Baseline Measures
    Subcutaneous (SC) Abatacept, 125 mg     Intravenous (IV) Abatacept, 125 mg     Total  
Number of Participants  
[units: participants]
 		  59     59     118  
Age  
[units: Years]
Mean ± Standard Deviation 		  56.1  ± 12.3     55.2  ± 13.6     55.6  ± 12.9  
Gender  
[units: Participants]
 		     
Female     38     48     86  
Male     21     11     32  
Race/Ethnicity, Customized  
[units: Participants]
 		     
Japanese     58     59     117  
Asian (not Japanese)     1     0     1  
Duration of Disease  
[units: Years]
Mean ± Standard Deviation 		  7.5  ± 9.2     5.3  ± 7.3     6.4  ± 8.3  
Duration of Disease Category  
[units: Participants]
 		     
<= 2 years     25     30     55  
>2 to <= 5 years     7     11     18  
>5 to <= 10 years     10     6     16  
>10 years     17     12     29  
Tender Joint Count  
[units: Number of joints]
Mean ± Standard Deviation 		  20.9  ± 9.3     22.3  ± 9.9     21.6  ± 9.6  
Swollen Joint Count  
[units: Number of joints]
Mean ± Standard Deviation 		  16.4  ± 7.0     17.6  ± 7.2     17.0  ± 7.1  
DAS28-CRP [1]
[units: Units on a scale]
Mean ± Standard Deviation 		  5.62  ± 0.84     5.95  ± 0.91     5.79  ± 0.89  
HAQ-DI Score [2]
[units: Units on a scale]
Mean ± Standard Deviation 		  1.28  ± 0.690     1.32  ± 0.64     1.30  ± 0.66  
Methotrexate dose [3]
[units: mg/week]
Mean ± Standard Deviation 		  7.3  ± 1.0     7.3  ± 1.0     7.3  ± 0.9  
[1] The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS (greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
[2] The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3.
[3] The methotrexate dose is the calculated weekly total dose in the week ending at the first dose date of the Short-term Period.



  Outcome Measures
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1.  Primary:   Percentage of Participants With an American College of Rheumatology (ACR) 20 Response   [ Time Frame: At Day 169 from Baseline ]
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2.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 50 and ACR70 Responses   [ Time Frame: At Day 169 from Baseline ]
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3.  Secondary:   Mean Change From Baseline in HAQ-DI Score   [ Time Frame: Baseline to Day 169 ]
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4.  Secondary:   Percentage of Participants With HAQ-DI Response   [ Time Frame: At Day 169 from Baseline ]
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5.  Secondary:   Mean Change in DAS28-CRP From Baseline   [ Time Frame: At Day 169 from Baseline ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169   [ Time Frame: At Day 169 from Baseline ]
  Show Outcome Measure 6

7.  Secondary:   Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs   [ Time Frame: Baseline to Day 169 ]
  Show Outcome Measure 7

8.  Secondary:   Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs   [ Time Frame: Baseline to Day 533 and up to 56 days following last dose in Long-Term period ]
  Show Outcome Measure 8

9.  Secondary:   Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality   [ Time Frame: Baseline to Day 169 ]
  Show Outcome Measure 9

10.  Secondary:   Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria   [ Time Frame: Baseline to Day 533 ]
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11.  Secondary:   Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality   [ Time Frame: Baseline to Day 169 ]
  Show Outcome Measure 11

12.  Secondary:   Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality   [ Time Frame: Baseline to Day 169 ]
  Show Outcome Measure 12

13.  Secondary:   Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality   [ Time Frame: Baseline to Day 533 ]
  Show Outcome Measure 13

14.  Secondary:   Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality   [ Time Frame: Baseline to Day 533 ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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.  


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: NCT01001832     History of Changes
Other Study ID Numbers: IM101-250
Study First Received: October 26, 2009
Results First Received: October 22, 2012
Last Updated: January 8, 2013
Health Authority: Japan: Institutional Review Board
Japan: Pharmaceuticals and Medical Devices Agency