Phase IIIB Subcutaneous Missed Dose Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00533897

First received: September 20, 2007

Last updated: June 26, 2012

Last verified: June 2012

History of Changes

Results First Received: January 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Interventions:	Drug: Abatacept Drug: Placebo

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
270 participants were enrolled and 167 participants were treated on study. 103 participants were not treated (10 withdrew consent, 2 lost to follow-up, 91 no longer met study criteria).

Reporting Groups

	Description
Abatacept (ABA) [Lead-In (LI)]	On Day 1 of the LI Period, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78 of the LI Period.
ABA [Double-blind (DBW)]	After receiving ABA in the LI Period, participants received ABA SC injections (fixed dose of 125 mg) in the DBW Period starting on Day 85 and weekly for 12 weeks
Placebo (PLA) [DBW]	After receiving ABA in the LI Period, participants received PLA SC injections in the DBW Period starting on Day 85 and weekly for 12 weeks.
ABA With IV PLA Loading Dose [Re-introduction (RI)]	After receiving ABA in LI Period, and ABA in the DBW Period, participants received a single placebo IV dose on Day 169 and continued with weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg) in the RI Period.
PLA Switched to ABA With ABA IV Loading Dose [RI]	After receiving ABA in the LI Period, and PLA in the DBW Period, participants received a single weight-titered ABA IV loading dose (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
PLA Switched to ABA With PLA IV Loading Dose [RI]	After receiving ABA in the LI Period, and PLA in the DBW Period, participants received a single PLA IV loading dose followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
LI Period Non-responders [Long-term Extension (LTE)]	On Day 1 of the LI Period, participants received a single weight-titered intravenous (IV) ABA loading dose (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following the loading dose, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78 (12 weeks) in the LI Period. After 12 weeks in the LI Period, these participants were found to have no response to ABA upon evaluation. These participants did not complete the ST or receive any DBW or RI treatment, and entered the Long Term Extension Period directly.
ABA in DBW Short Term (ST) Completers [LTE]	Participants who received ABA during the LI Period, ABA during the DBW, continued ABA during the RI Period, and who successfully completed the Short Term of the study, went on to receive weekly open-label SC abatacept (fixed dose of 125 mg) in the LTE.
PLA in DBW Short Term (ST) Completers, [LTE]	Participants who received ABA during the LI Period, PLA during the DBW, switched to ABA in the RI Period (with either ABA or PLA IV loading dose), and who successfully completed the Short Term of the study, went on to receive weekly open-label SC abatacept (fixed dose of 125 mg) in the LTE.

Participant Flow for 4 periods

Period 1: Lead-in (LI) Period

	Abatacept (ABA) [Lead-In (LI)]	ABA [Double-blind (DBW)]	Placebo (PLA) [DBW]	ABA With IV PLA Loading Dose [Re-introduction (RI)]	PLA Switched to ABA With ABA IV Loading Dose [RI]	PLA Switched to ABA With PLA IV Loading Dose [RI]	LI Period Non-responders [Long-term Extension (LTE)]	ABA in DBW Short Term (ST) Completers [LTE]	PLA in DBW Short Term (ST) Completers, [LTE]
STARTED	167	0	0	0	0	0	0	0	0
COMPLETED	157 ^[1]	0	0	0	0	0	0	0	0
NOT COMPLETED	10	0	0	0	0	0	0	0	0
Adverse Event	1	0	0	0	0	0	0	0	0
Participant Withdrew Consent	2	0	0	0	0	0	0	0	0
Lost to Follow-up	1	0	0	0	0	0	0	0	0
Administrative Reason By Sponsor	2	0	0	0	0	0	0	0	0
Lack of Efficacy	3	0	0	0	0	0	0	0	0
Missed 2 Consecutive Doses of Study Drug	1	0	0	0	0	0	0	0	0

[1]	37 participants entered the LTE directly and did not enter the DBW Period nor receive DBW treatment.

Period 2: Double-blind Withdrawal (DBW) Period

	ABA [Double-blind (DBW)]	Placebo (PLA) [DBW]
STARTED	40	80
COMPLETED	39 ^[1]	77 ^[2]
NOT COMPLETED	1	3
Lack of Efficacy	1	2
Poor/Non-Compliance	0	1

[1]	One participant discontinued the DBW Period due to Lack of Efficacy to enter the RI Period early
[2]	Two participants discontinued the DBW Period due to Lack of Efficacy to enter the RI Period early

Period 3: Re-introduction (RI) Period

	ABA With IV PLA Loading Dose [Re-introduction (RI)]	PLA Switched to ABA With ABA IV Loading Dose [RI]	PLA Switched to ABA With PLA IV Loading Dose [RI]
STARTED	40 ^[1]	35 ^[1]	44 ^[1]
COMPLETED	40	35	42
NOT COMPLETED	0	0	2
Participant Withdrew Consent	0	0	1
No Longer Meets Study Criteria	0	0	1

[1]	1 participant discontinued the DBW Period due to Lack of Efficacy to enter RI Period early

Period 4: Open-label-Long Term Extension (LTE)

	LI Period Non-responders [Long-term Extension (LTE)]	ABA in DBW Short Term (ST) Completers [LTE]	PLA in DBW Short Term (ST) Completers, [LTE]
STARTED	37	39	74
PARTICIPANTS ONGOING	30	38	70
COMPLETED	0	0	0
NOT COMPLETED	37	39	74
Participant Withdrew Consent	1	0	2
Death	1	0	0
Lack of Efficacy	2	0	0
Poor/Non-compliance	2	0	0
Response Evaluated Incorrectly	1	0	0
Participant Relocation	0	0	1
Refused Transfer To Other Site	0	1	1
Participant Is Ongoing On Study	30	38	70

Baseline Characteristics

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Reporting Groups

	Description
ABA [DBW]	Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
Placebo (PLA) [DBW]	Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
Total	Total of all reporting groups

Baseline Measures

	ABA [DBW]	Placebo (PLA) [DBW]	Total
Number of Participants [units: participants]	40	80	120
Age [units: years] Mean ± Standard Deviation	48.9 ± 14.2	49.1 ± 12.8	49.0 ± 13.2
Gender [units: participants]
Female	34	67	101
Male	6	13	19

Outcome Measures

Show All Outcome Measures

1. Primary:

Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbant Assay (ELISA) at Day 169 [ Time Frame: Day 169 ]

Show Outcome Measure 1

2. Primary:

Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups [ Time Frame: Day 253 (short term) ]

Show Outcome Measure 2

3. Secondary:

RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group [ Time Frame: Day 253 (short term) ]

Show Outcome Measure 3

4. Secondary:

Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time [ Time Frame: For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug ]

Show Outcome Measure 4

5. Secondary:

LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time [ Time Frame: For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug ]

Show Outcome Measure 5

6. Secondary:

DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time [ Time Frame: Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period ]

Show Outcome Measure 6

7. Secondary:

DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Post Visits [ Time Frame: Day 22 after last dose of drug to Day 85 after last dose of drug ]

Show Outcome Measure 7

8. Secondary:

DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time [ Time Frame: Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period ]

Show Outcome Measure 8

9. Secondary:

DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL At Post Visits [ Time Frame: Day 22 after last dose of drug to Day 85 after last dose of drug ]

Show Outcome Measure 9

10. Secondary:

RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time [ Time Frame: For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug ]

Show Outcome Measure 10

11. Secondary:

RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time [ Time Frame: For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug ]

Show Outcome Measure 11

12. Secondary:

Short Term Period (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups [ Time Frame: For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug ]

Show Outcome Measure 12

13. Secondary:

Short Term Period; Number of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups [ Time Frame: For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug ]

Show Outcome Measure 13

14. Secondary:

Short Term Period; Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups [ Time Frame: Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term period) ]

Show Outcome Measure 14

15. Secondary:

Short Term Period; Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups [ Time Frame: Days 85, 169, and 253 (short term period) ]

Show Outcome Measure 15

16. Secondary:

Short Term Period; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups [ Time Frame: Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term period) ]

Show Outcome Measure 16

17. Secondary:

Short Term Period; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups [ Time Frame: Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term period) ]

Show Outcome Measure 17

18. Secondary:

LI; Mean Change in DAS 28 (CRP) From Baseline Over Time [ Time Frame: Days 1 (Baseline), 15, 29, 57, 78, 85 ]

Show Outcome Measure 18

19. Secondary:

LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time [ Time Frame: Days 15, 29, 57, 78, 85 ]

Show Outcome Measure 19

20. Secondary:

DBW Period; Mean Change in DAS 28 (CRP) From DBW Period Baseline (Day 85) Over Time [ Time Frame: Days 85 (Period II Baseline), 113, 141, and 169 ]

Show Outcome Measure 20

21. Secondary:

DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time [ Time Frame: Days 85, 113, 141, and 169 ]

Show Outcome Measure 21

22. Secondary:

RI Period; Mean Change in DAS 28 (CRP) From RI Period Baseline (Day 169) Over Time [ Time Frame: Days 169 (Period III Baseline), 197, 225, and 253 ]

Show Outcome Measure 22

23. Secondary:

LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

Hide Outcome Measure 23

Measure Type	Secondary
Measure Title	LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation
Measure Description	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Time Frame	From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier
Safety Issue	Yes

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.
Participants who received at least 1 dose of study medication during LI period

Reporting Groups

	Description
ABA [LI]	On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.

Measured Values

	ABA [LI]
Number of Participants Analyzed [units: participants]	167
LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation [units: participants]
Deaths	1
SAEs	3
Related SAEs	0
SAEs Leading to Discontinuation	1
AEs	82
Related AEs	29
AEs Leading to Discontinuation	1

No statistical analysis provided for LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation

24. Secondary:

LI; Number of Participants With AEs of Special Interest [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

Show Outcome Measure 24

25. Secondary:

LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

Show Outcome Measure 25

26. Secondary:

LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

Show Outcome Measure 26

27. Secondary:

LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

Show Outcome Measure 27

28. Secondary:

LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria [ Time Frame: From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier ]

Show Outcome Measure 28

29. Secondary:

LI; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period I [ Time Frame: Days 1, 15, 29, 57, 78, and 85 ]

Show Outcome Measure 29

30. Secondary:

LI; Mean Heart Rate (HR) During Period I [ Time Frame: Days 1, 15, 29, 57, 78, and 85 ]

Show Outcome Measure 30

31. Secondary:

LI; Mean Temperature (T) During Period I [ Time Frame: Days 1, 15, 29, 57, 78, and 85 ]

Show Outcome Measure 31

32. Secondary:

DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

Show Outcome Measure 32

33. Secondary:

DBW; Number of Participants With AEs of Special Interest [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

Show Outcome Measure 33

34. Secondary:

DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

Show Outcome Measure 34

35. Secondary:

DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

Show Outcome Measure 35

36. Secondary:

DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

Show Outcome Measure 36

37. Secondary:

DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria [ Time Frame: From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier ]

Show Outcome Measure 37

38. Secondary:

DBW Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period II [ Time Frame: Days 113, 141, and 169 ]

Show Outcome Measure 38

39. Secondary:

DBW Period; Mean Heart Rate (HR) During Period II [ Time Frame: Days 113, 141, and 169 ]

Show Outcome Measure 39

40. Secondary:

DBW Period; Mean Temperature (T) During Period II [ Time Frame: Days 113, 141, and 169 ]

Show Outcome Measure 40

41. Secondary:

RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

Show Outcome Measure 41

42. Secondary:

RI; Number of Participants With AEs of Special Interest [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

Show Outcome Measure 42

43. Secondary:

RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

Show Outcome Measure 43

44. Secondary:

RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

Show Outcome Measure 44

45. Secondary:

RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

Show Outcome Measure 45

46. Secondary:

RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria [ Time Frame: From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier. ]

Show Outcome Measure 46

47. Secondary:

RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III [ Time Frame: Days 169, 197, 225, and 253 ]

Show Outcome Measure 47

48. Secondary:

RI Period; Mean Heart Rate (HR) During Period III [ Time Frame: Days 169, 197, 225, and 253 ]

Show Outcome Measure 48

49. Secondary:

RI Period; Mean Temperature (T) During Period III [ Time Frame: Days 169, 197, 225, and 253 ]

Show Outcome Measure 49

50. Secondary:

Long Term Extension (LTE); Number of Participants With Death, SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation [ Time Frame: For Period I non-responders: as of Day 85 and up to data cut-off for database lock (15Dec09). For Period II completers: as of Day 253 and up to data cut-off for database lock (15Dec09). Data included up to 56 days post last dose. ]

Show Outcome Measure 50

51. Secondary:

LTE; Number of Participants With AEs of Special Interest [ Time Frame: For Period I non-responders: as of Day 85 and up to data cut-off for database lock (15Dec09). For Period II completers: as of Day 253 and up to data cut-off for database lock (15Dec09). Data included up to 56 days post last dose. ]

Show Outcome Measure 51

52. Secondary:

LTE; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria [ Time Frame: For Period I non-responders: as of Day 85 and up to data cut-off for database lock (15Dec09). For Period II completers: as of Day 253 and up to data cut-off for database lock (15Dec09). Data included up to 56 days post last dose. ]

Show Outcome Measure 52

53. Secondary:

LTE; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria [ Time Frame: For Period I non-responders: as of Day 85 and up to data cut-off for database lock (15Dec09). For Period II completers: as of Day 253 and up to data cut-off for database lock (15Dec09). Data included up to 56 days post last dose. ]

Show Outcome Measure 53

54. Secondary:

LTE; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria [ Time Frame: For Period I non-responders: as of Day 85 and up to data cut-off for database lock (15Dec09). For Period II completers: as of Day 253 and up to data cut-off for database lock (15Dec09). Data included up to 56 days post last dose. ]

Show Outcome Measure 54

55. Secondary:

LTE; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria [ Time Frame: For Period I non-responders: as of Day 85 and up to data cut-off for database lock (15Dec09). For Period II completers: as of Day 253 and up to data cut-off for database lock (15Dec09). Data included up to 56 days post last dose. ]

Show Outcome Measure 55

56. Secondary:

LTE; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period LTE [ Time Frame: Days 337, 365, and 449 ]

Show Outcome Measure 56

57. Secondary:

LTE; Mean Heart Rate (HR) During Period LTE [ Time Frame: Days 337, 365, and 449 ]

Show Outcome Measure 57

58. Secondary:

LTE; Mean Temperature (T) During Period LTE [ Time Frame: Days 337, 365, and 449 ]

Show Outcome Measure 58

59. Secondary:

Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups [ Time Frame: Day 197 through Day 253 ]

Show Outcome Measure 59

60. Secondary:

Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups [ Time Frame: Day 197 through Day 253 ]

Show Outcome Measure 60

61. Secondary:

ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups [ Time Frame: Baseline, Day 253 ]

Show Outcome Measure 61

Serious Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

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:

Kaine J, Gladstein G, Strusberg I, Robles M, Louw I, Gujrathi S, Pappu R, Delaet I, Pans M, Ludivico C. Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase Iiib ALLOW study). Ann Rheum Dis. 2012 Jan;71(1):38-44. Epub 2011 Sep 13.

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00533897 History of Changes
Other Study ID Numbers:	IM101-167
Study First Received:	September 20, 2007
Results First Received:	January 10, 2011
Last Updated:	June 26, 2012
Health Authority:	United States: Food and Drug Administration

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