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Study Results
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Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
This study has been completed.
Study NCT00095147   Information provided by Bristol-Myers Squibb

First Received on November 1, 2004.   Last Updated on December 21, 2010   History of Changes
Results First Received: October 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)
Drug: Infliximab (INF) + MTX, DB
Drug: Placebo (PLA) + MTX, DB
Drug: PLA + MTX switched to ABA+ MTX, DB
Drug: ABA, open-label (OL)

  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
748 participants enrolled in this study; 317 participants were not randomized or treated. 384 participants completed the double-blind period; 12 participants did not enter the open-label period.

Reporting Groups
  Description
Abatacept (ABA) + Methotrexate (MTX) [Double-blind (DB)] Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
Infliximab (INF) + MTX [DB] Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
Placebo (PLA) + MTX [DB] Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
PLA Switched to ABA + MTX [DB] Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
ABA + MTX [Open-label (OL)] All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).

Participant Flow for 3 periods

 Period 1:   Double-blind Period 1 (Days 1-197)
    Abatacept (ABA) + Methotrexate (MTX) [Double-blind (DB)]     Infliximab (INF) + MTX [DB]     Placebo (PLA) + MTX [DB]     PLA Switched to ABA + MTX [DB]     ABA + MTX [Open-label (OL)]  
STARTED     156     165     110     0     0  
COMPLETED     147     152     107     0     0  
NOT COMPLETED     9     13     3     0     0  
Death                 1                 0                 0                 0                 0  
Adverse Event                 2                 8                 1                 0                 0  
Lack of Efficacy                 2                 2                 1                 0                 0  
Lost to Follow-up                 2                 2                 0                 0                 0  
Withdrawal of consent                 1                 0                 1                 0                 0  
Pregnancy                 1                 1                 0                 0                 0  

Period 2:   Double-blind Period 2 (Days 198-365)
    Abatacept (ABA) + Methotrexate (MTX) [Double-blind (DB)]     Infliximab (INF) + MTX [DB]     Placebo (PLA) + MTX [DB]     PLA Switched to ABA + MTX [DB]     ABA + MTX [Open-label (OL)]  
STARTED     147     152     0     107     0  
COMPLETED     139     141     0     104     0  
NOT COMPLETED     8     11     0     3     0  
Death                 0                 1                 0                 1                 0  
Adverse Event                 2                 4                 0                 0                 0  
Lack of Efficacy                 2                 4                 0                 1                 0  
Withdrawal of consent                 3                 2                 0                 0                 0  
Participant relocation                 1                 0                 0                 1                 0  

Period 3:   Long-term Extension Period
    Abatacept (ABA) + Methotrexate (MTX) [Double-blind (DB)]     Infliximab (INF) + MTX [DB]     Placebo (PLA) + MTX [DB]     PLA Switched to ABA + MTX [DB]     ABA + MTX [Open-label (OL)]  
STARTED     0     0     0     0     372  
COMPLETED     0     0     0     0     327  
NOT COMPLETED     0     0     0     0     45  
Death                 0                 0                 0                 0                 3  
Adverse Event                 0                 0                 0                 0                 11  
Lack of Efficacy                 0                 0                 0                 0                 9  
Lost to Follow-up                 0                 0                 0                 0                 6  
Withdrawal of consent                 0                 0                 0                 0                 12  
Pregnancy                 0                 0                 0                 0                 1  
No longer meets study criteria                 0                 0                 0                 0                 1  
Participant chose to use Revellex                 0                 0                 0                 0                 1  
Leaving country                 0                 0                 0                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
ABA + MTX [DB] Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
INF + MTX [DB] Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
PLA + MTX [DB] Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)

Baseline Measures
    ABA + MTX [DB]     INF + MTX [DB]     PLA + MTX [DB]     Total  
Number of Participants  
[units: participants]
 		  156     165     110     431  
Age  
[units: years]
Mean ± Standard Deviation 		  49.0  ± 12.5     49.1  ± 12.0     49.4  ± 11.5     49.1  ± 12.0  
Gender  
[units: participants]
 		       
Female     130     136     96     362  
Male     26     29     14     69  
Baseline Disease Activity Score (DAS) 28 (Erythrocyte Sedimentation Rate [ESR]) [1]
[units: units on a scale]
Mean ± Standard Deviation 		  6.9  ± 1.0     6.8  ± 0.9     6.8  ± 1.0     6.8  ± 1.0  
[1] The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or C-reactive protein (CRP), and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   DB; Adjusted Mean Change From Baseline to Day 197 in Disease Activity Score (DAS) 28 Score (Erythrocyte Sedimentation Rate [ESR]) For ABA Versus PLA (Last Observation Carried Forward [LOCF] Analysis)   [ Time Frame: Baseline (Day 1), 6 months (Day 197) ]
  Show Outcome Measure 1

2.  Primary:   OL; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, and AEs Leading to Discontinuation   [ Time Frame: From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months) ]
  Show Outcome Measure 2

3.  Primary:   OL; Number of Participants With AEs of Special Interest   [ Time Frame: From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months) ]
  Show Outcome Measure 3

4.  Primary:   OL; Number of Participants With Select Hematologic Laboratory Abnormalities   [ Time Frame: From Day 366 through end of OL (range from 1.9 months to 42.3 months) ]
  Show Outcome Measure 4

5.  Primary:   OL; Number of Participants With Select Blood Chemistry Laboratory Abnormalities   [ Time Frame: From Day 366 through end of OL (range from 1.9 months to 42.3 months) ]
  Show Outcome Measure 5

6.  Primary:   OL; Mean Change From Baseline to Day 365 in Hemoglobin, Total Protein, and Albumin   [ Time Frame: Baseline (Day 1), Day 365 ]
  Show Outcome Measure 6

7.  Primary:   OL; Mean Change From Baseline to Day 365 in Platelets   [ Time Frame: Baseline (Day 1), Day 365 ]
  Show Outcome Measure 7

8.  Primary:   OL; Mean Change From Baseline to Day 365 in Hematocrit   [ Time Frame: Baseline (Day 1), Day 365 ]
  Show Outcome Measure 8

9.  Primary:   OL; Mean Change From Baseline to Day 365 in White Blood Cells   [ Time Frame: Baseline (Day 1), Day 365 ]
  Show Outcome Measure 9

10.  Primary:   OL; Mean Change From Baseline to Day 365 in Erythrocytes   [ Time Frame: Baseline (Day 1), Day 365 ]
  Show Outcome Measure 10

11.  Primary:   OL; Mean Change From Baseline to Day 365 in Electrolytes   [ Time Frame: Baseline (Day 1), Day 365 ]
  Show Outcome Measure 11

12.  Primary:   OL; Mean Change From Baseline to Day 365 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid   [ Time Frame: Baseline (Day 1), Day 365 ]
  Show Outcome Measure 12

13.  Primary:   OL; Mean Change From Baseline to Day 365 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase   [ Time Frame: Baseline (Day 1), Day 365 ]
  Show Outcome Measure 13

14.  Primary:   OL; Mean Change From Baseline to Day 729 in Hemoglobin, Total Protein, and Albumin   [ Time Frame: Baseline (Day 1), Day 729 ]
  Show Outcome Measure 14

15.  Primary:   OL; Mean Change From Baseline to Day 729 in Platelets   [ Time Frame: Baseline (Day 1), Day 729 ]
  Show Outcome Measure 15

16.  Primary:   OL; Mean Change From Baseline to Day 729 in Hematocrit   [ Time Frame: Baseline (Day 1), Day 729 ]
  Show Outcome Measure 16

17.  Primary:   OL; Mean Change From Baseline to Day 729 in White Blood Cells   [ Time Frame: Baseline (Day 1), Day 729 ]
  Show Outcome Measure 17

18.  Primary:   OL; Mean Change From Baseline to Day 729 in Erythrocytes   [ Time Frame: Baseline (Day 1), Day 729 ]
  Show Outcome Measure 18

19.  Primary:   OL; Mean Change From Baseline to Day 729 in Electrolytes   [ Time Frame: Baseline (Day 1), Day 729 ]
  Show Outcome Measure 19

20.  Primary:   OL; Mean Change From Baseline to Day 729 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid   [ Time Frame: Baseline (Day 1), Day 729 ]
  Show Outcome Measure 20

21.  Primary:   OL; Mean Change From Baseline to Day 729 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase   [ Time Frame: Baseline (Day 1), Day 729 ]
  Show Outcome Measure 21

22.  Primary:   OL; Mean Change From Baseline to Day 1121 in Hemoglobin, Total Protein, and Albumin   [ Time Frame: Baseline (Day 1), Day 1121 ]
  Show Outcome Measure 22

23.  Primary:   OL; Mean Change From Baseline to Day 1121 in Platelets   [ Time Frame: Baseline (Day 1), Day 1121 ]
  Show Outcome Measure 23

24.  Primary:   OL; Mean Change From Baseline to Day 1121 in Hematocrit   [ Time Frame: Baseline (Day 1), Day 1121 ]
  Show Outcome Measure 24

25.  Primary:   OL; Mean Change From Baseline to Day 1121 in White Blood Cells   [ Time Frame: Baseline (Day 1), Day 1121 ]
  Show Outcome Measure 25

26.  Primary:   OL; Mean Change From Baseline to Day 1121 in Erythrocytes   [ Time Frame: Baseline (Day 1), Day 1121 ]
  Show Outcome Measure 26

27.  Primary:   OL; Mean Change From Baseline to Day 1121 in Electrolytes   [ Time Frame: Baseline (Day 1), Day 1121 ]
  Show Outcome Measure 27

28.  Primary:   OL; Mean Change From Baseline to Day 1121 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid   [ Time Frame: Baseline (Day 1), Day 1121 ]
  Show Outcome Measure 28

29.  Primary:   OL; Mean Change From Baseline to Day 1121 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase   [ Time Frame: Baseline (Day 1), Day 1121 ]
  Show Outcome Measure 29

30.  Primary:   OL; Mean Change From Baseline to Day 1513 in Hemoglobin, Total Protein, and Albumin   [ Time Frame: Baseline (Day 1), Day 1513 ]
  Show Outcome Measure 30

31.  Primary:   OL; Mean Change From Baseline to Day 1513 in Platelets   [ Time Frame: Baseline (Day 1), Day 1513 ]
  Show Outcome Measure 31

32.  Primary:   OL; Mean Change From Baseline to Day 1513 in Hematocrit   [ Time Frame: Baseline (Day 1), Day 1513 ]
  Show Outcome Measure 32

33.  Primary:   OL; Mean Change From Baseline to Day 1513 in White Blood Cells   [ Time Frame: Baseline (Day 1), Day 1513 ]
  Show Outcome Measure 33

34.  Primary:   OL; Mean Change From Baseline to Day 1513 in Erythrocytes   [ Time Frame: Baseline (Day 1), Day 1513 ]
  Show Outcome Measure 34

35.  Primary:   OL; Mean Change From Baseline to Day 1513 in Electrolytes   [ Time Frame: Baseline (Day 1), Day 1513 ]
  Show Outcome Measure 35

36.  Primary:   OL; Mean Change From Baseline to Day 1513 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid   [ Time Frame: Baseline (Day 1), Day 1513 ]
  Show Outcome Measure 36

37.  Primary:   OL; Mean Change From Baseline to Day 1513 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase   [ Time Frame: Baseline (Day 1), Day 1513 ]
  Show Outcome Measure 37

38.  Primary:   OL; Mean Systolic (SBP) and Diastolic (DBP) Blood Pressure During Open Label Period   [ Time Frame: Days 365, 729, 1121, and 1513 ]
  Show Outcome Measure 38

39.  Primary:   OL; Mean Heart Rate (HR) During Open Label Period   [ Time Frame: Days 365, 729, 1121, and 1513 ]
  Show Outcome Measure 39

40.  Primary:   OL; Mean Temperature (T) During Open Label Period   [ Time Frame: Days 365, 729, 1121, and 1513 ]
  Show Outcome Measure 40

41.  Secondary:   DB; Adjusted Mean Change From Baseline to Day 197 in DAS 28 Score (ESR) For INF Versus PLA (LOCF Analysis)   [ Time Frame: Baseline (Day 1), 6 months (Day 197) ]
  Show Outcome Measure 41

42.  Secondary:   DB; DAS 28 (ESR) Area Under The Curve (AUC) Over 12 Months For ABA Versus INF   [ Time Frame: From Day 1 through Day 365 (12 months) ]
  Show Outcome Measure 42

43.  Secondary:   DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 197   [ Time Frame: DB Day 197 ]
  Show Outcome Measure 43

44.  Secondary:   DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 365   [ Time Frame: DB Day 365 ]
  Show Outcome Measure 44

45.  Secondary:   DB; Adjusted Mean Change From Baseline to Day 197 in HAQ-DI (LOCF Analysis)   [ Time Frame: Baseline (Day 1), 6 months (Day 197) ]
  Show Outcome Measure 45

46.  Secondary:   DB; Adjusted Mean Change From Baseline to Day 365 in HAQ-DI (LOCF Analysis)   [ Time Frame: Baseline (Day 1), 12 months (Day 365) ]
  Show Outcome Measure 46

47.  Secondary:   DB; Adjusted Mean Change From Baseline to Day 197 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)   [ Time Frame: Baseline (Day 1), 6 months (Day 197) ]
  Show Outcome Measure 47

48.  Secondary:   DB; Adjusted Mean Change From Baseline to Day 365 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)   [ Time Frame: Baseline (Day 1), 12 months (Day 365) ]
  Show Outcome Measure 48

49.  Secondary:   DB; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) at Day 365   [ Time Frame: DB Day 365 ]
  Show Outcome Measure 49

50.  Secondary:   DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 197   [ Time Frame: DB Day 197 ]
  Show Outcome Measure 50

51.  Secondary:   DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 365   [ Time Frame: DB Day 365 ]
  Show Outcome Measure 51

52.  Secondary:   DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 197   [ Time Frame: From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study ]
  Show Outcome Measure 52

53.  Secondary:   DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 197   [ Time Frame: From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study ]
  Show Outcome Measure 53

54.  Secondary:   DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 365   [ Time Frame: From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study ]
  Show Outcome Measure 54

55.  Secondary:   DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept   [ Time Frame: From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study ]
  Show Outcome Measure 55

56.  Secondary:   DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 365   [ Time Frame: From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study ]
  Show Outcome Measure 56

57.  Secondary:   DB; Number of Participants With AEs of Special Interest From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept   [ Time Frame: From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study ]
  Show Outcome Measure 57

58.  Secondary:   DB; Number of Participants With Significant Changes in Mean Systolic and Diastolic Blood Pressure During Days 1 Through 197 and Days 1 Through 365   [ Time Frame: From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study ]
  Show Outcome Measure 58

59.  Secondary:   DB; Number of Participants With Significant Changes in Mean Heart Rate During Days 1 Through 197 and Days 1 Through 365   [ Time Frame: From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study ]
  Show Outcome Measure 59

60.  Secondary:   DB; Number of Participants With Significant Changes in Mean Temperature During Days 1 Through 197 and Days 1 Through 365   [ Time Frame: From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study ]
  Show Outcome Measure 60

61.  Secondary:   DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 197   [ Time Frame: From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study ]
  Show Outcome Measure 61

62.  Secondary:   DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 365   [ Time Frame: From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study ]
  Show Outcome Measure 62

63.  Secondary:   DB; Number of Participants With Anti-Abatacept Antibodies From Day 1 Through Day 365 (Electrochemiluminescent [ECL] Immunoassay)   [ Time Frame: Day 1 through day 365 ]
  Show Outcome Measure 63

64.  Secondary:   DB; Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA]) From Day 1 Through Day 365   [ Time Frame: Day 1 through day 365 ]
  Show Outcome Measure 64

65.  Secondary:   OL; Mean Change From Baseline Over Time in DAS 28 (ESR) Score   [ Time Frame: Baseline (Day 1), Day 365, Day 533, Day 729 ]
  Show Outcome Measure 65

66.  Secondary:   OL; Percentage of Participants With DAS28 (ESR) Remission and Low Disease Activity (LDAS) Over Time   [ Time Frame: Baseline (Day 1), Day 365, Day 533, Day 729 ]
  Show Outcome Measure 66

67.  Secondary:   OL; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Over Time   [ Time Frame: DB Days 365, 533, and 729 ]
  Show Outcome Measure 67

68.  Secondary:   OL; Percentage of Participants With American College of Rheumatology (ACR) Responses Over Time   [ Time Frame: DB Day 197, Day 365, Day 533, Day 729 ]
  Show Outcome Measure 68

69.  Secondary:   OL; Percentage of Participants Who Achieved Major Clinical Response   [ Time Frame: Defined from the date of achieving ACR 70 response to 6 months post response ]
  Show Outcome Measure 69

70.  Secondary:   OL; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Over Time   [ Time Frame: OL Days 197, 253, 281, 309, 337, 365, 449, 533, 617, and 729 ]
  Show Outcome Measure 70

71.  Secondary:   OL; Adjusted Mean Change From Baseline to Day 729 in HAQ-DI   [ Time Frame: Day 1 (Baseline), Day 729 ]
  Show Outcome Measure 71


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  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: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:
Schiff M, Keiserman M, Codding C, Songcharoen S, Berman A, Nayiager S, Saldate C, Li T, Aranda R, Becker JC, Lin C, Cornet PL, Dougados M. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2008 Aug;67(8):1096-103. Epub 2007 Nov 29.


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00095147     History of Changes
Other Study ID Numbers: IM101-043
Study First Received: November 1, 2004
Results First Received: October 26, 2010
Last Updated: December 21, 2010
Health Authority: United States: Food and Drug Administration





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