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A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00048932
Recruitment Status : Completed
First Posted : November 13, 2002
Results First Posted : May 3, 2011
Last Update Posted : November 24, 2011
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Double-blind Abatacept
Drug: Double-blind Placebo
Drug: Open-label Abatacept

  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
1795 enrolled in study and 339 were not randomized due to no longer meeting study criteria (n=214), withdraw of consent (n=83), other reasons (n=32), participant was lost to follow-up (n=5), administrative reason by sponsor (n=2), adverse event (n=2), and poor/non-compliance (n=1). Of 1456 randomized, 15 were not treated.

Reporting Groups
  Description
Abatacept (ABA) Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
Placebo (PLA) Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
Open Label (OL) Abatacept Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.

Participant Flow for 2 periods

 Period 1:   Double Blind Period (DB)
    Abatacept (ABA)   Placebo (PLA)   Open Label (OL) Abatacept
STARTED   959 [1]   482 [1]   0 
COMPLETED   836   395   0 
NOT COMPLETED   123   87   0 
Administrative Reason By Sponsor                1                0                0 
Adverse Event                51                19                0 
Death                5                3                0 
Lack of Efficacy                26                44                0 
Lost to Follow-up                3                4                0 
Relocation                1                0                0 
Uncontrolled hypertension                0                1                0 
Missed 2 doses while undergoing work-up                1                0                0 
Pregnancy                1                0                0 
No Longer Meets Study Criteria                8                2                0 
Withdrawal by Subject                24                10                0 
Poor/Non-Compliance                2                4                0 
[1] Number Treated

Period 2:   Open Label Period (OL)
    Abatacept (ABA)   Placebo (PLA)   Open Label (OL) Abatacept
STARTED   0   0   1184 [1] 
COMPLETED   0   0   743 
NOT COMPLETED   0   0   441 
Death                0                0                25 
Adverse Event                0                0                103 
Lack of Efficacy                0                0                81 
Lost to Follow-up                0                0                27 
Withdrawal by Subject                0                0                117 
No Longer Meets Study Criteria                0                0                5 
Poor/Non-Compliance                0                0                13 
Pregnancy                0                0                6 
Administrative Reason By Sponsor                0                0                20 
Investigator Retiring                0                0                2 
Participant Transportation Issues                0                0                1 
Participant Relocated                0                0                6 
Investigator Dosing the Trial                0                0                1 
Site Closure                0                0                3 
Trial Terminated                0                0                1 
Difficult IV Access with Participant                0                0                1 
Patient Decision                0                0                4 
Participant Received Wrong Medication                0                0                1 
Participant Desires Pregnancy                0                0                2 
Participant Missed Consecutive Doses                0                0                5 
Medication Lost Efficacy                0                0                1 
Investigator Decision                0                0                4 
Site Staff Issues                0                0                2 
Site Not Participating in Open Label                0                0                9 
Participant Surgery                0                0                1 
[1] 47 participants who completed the double-blind did not enter the open-label



  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.
No text entered.

Reporting Groups
  Description
Abatacept (ABA) Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
Placebo (PLA) Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
Total Total of all reporting groups

Baseline Measures
   Abatacept (ABA)   Placebo (PLA)   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 959   482   1441 
Age 
[Units: Years]
Mean (Standard Deviation) 		 52.4  (11.7)   52.1  (12.0)   52.3  (11.8) 
Gender 
[Units: Participants]
 		     
Female   789   398   1187 
Male   170   84   254 


  Outcome Measures

1.  Primary:   Double Blind Period (DB); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation   [ Time Frame: Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication ]
  Show Outcome Measure 1

2.  Primary:   DB; Number of Participants With AEs of Special Interest   [ Time Frame: Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication ]
  Show Outcome Measure 2

3.  Primary:   DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria   [ Time Frame: Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication ]
  Show Outcome Measure 3

4.  Primary:   DB; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality (MA) Criteria   [ Time Frame: Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication ]
  Show Outcome Measure 4

5.  Primary:   DB; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities   [ Time Frame: Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337. Vital signs were measured at these visits before and after study medication infusion. ]
  Show Outcome Measure 5

6.  Primary:   Open Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation   [ Time Frame: Day 365 to Day 1,821 ]
  Show Outcome Measure 6

7.  Primary:   OL; Number of Participants With AEs of Special Interest   [ Time Frame: Day 365 to Day 1821 ]
  Show Outcome Measure 7

8.  Primary:   OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria   [ Time Frame: Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication ]
  Show Outcome Measure 8

9.  Primary:   OL; Number of Participants With Liver Function Laboratories Meeting Marked Abnormality Criteria   [ Time Frame: Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication ]
  Show Outcome Measure 9

10.  Primary:   OL; Number of Participants With Electrolyte Laboratories Meeting Marked Abnormality Criteria   [ Time Frame: Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication ]
  Show Outcome Measure 10

11.  Primary:   OL; Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting Marked Abnormality Criteria   [ Time Frame: Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication ]
  Show Outcome Measure 11

12.  Primary:   OL; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities   [ Time Frame: Days 365 to Day 1821 ]
  Show Outcome Measure 12

13.  Secondary:   DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)   [ Time Frame: Days 1, 29, 57, 85, 113,169, 281, 365 ]
  Show Outcome Measure 13

14.  Secondary:   DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA   [ Time Frame: Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337 ]
  Show Outcome Measure 14


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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: BMS 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: NCT00048932     History of Changes
Other Study ID Numbers: IM101-031
First Submitted: November 11, 2002
First Posted: November 13, 2002
Results First Submitted: April 1, 2011
Results First Posted: May 3, 2011
Last Update Posted: November 24, 2011