A Study of Abatacept in Patients With Active Ulcerative Colitis

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00410410

First received: December 11, 2006

Last updated: November 4, 2010

Last verified: November 2010

History of Changes

Results First Received: August 12, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Ulcerative Colitis
Interventions:	Drug: abatacept (ABA) Drug: placebo 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
In this study, a first cohort (Induction Period First Cohort, IP1C) of 490 participants was randomized and used for analysis of the primary endpoint. Following randomization of IP1C, a second cohort (IP2C) of 146 participants was randomized to provide a sufficient number of participants for the Maintenance Period.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Induction Period Cohort 1 (IP1C)-Abatacept (ABA) 30/~10 mg/kg	During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
IP1C-ABA ~10 mg/kg	During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
IP1C-ABA 3 mg/kg	During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
IP1C-Placebo	During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg	During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
IP2C-ABA ~10 mg/kg	During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
ABA ~10 mg/kg, Maintenance Period (MP)	During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
Placebo, MP	During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
ABA ~10 mg/kg, Open-Label Period (OL)	During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.

Participant Flow for 3 periods

Period 1: Induction Period (IP)

	Induction Period Cohort 1 (IP1C)-Abatacept (ABA) 30/~10 mg/kg	IP1C-ABA ~10 mg/kg	IP1C-ABA 3 mg/kg	IP1C-Placebo	IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg	IP2C-ABA ~10 mg/kg
STARTED	141	139	70	140	51	50
COMPLETED	106	104	53	120	19	21
NOT COMPLETED	35	35	17	20	32	29
Death	1	0	0	0	0	0
Adverse Event	3	4	2	4	1	0
Lack of Efficacy	26	24	8	8	7	7
Lost to Follow-up	2	2	2	3	0	1
Withdrawal by Subject	3	5	3	5	2	0
Subject No Longer Meets Study Criteria	0	0	1	0	0	0
Poor/Non-compliance	0	0	0	0	0	0
Pregnancy	0	0	0	0	0	0
Administrative Reason By Sponsor	0	0	0	0	22	21
Other	0	0	1	0	0	0

Period 2: Maintenance Period (MP)

	ABA ~10 mg/kg, Maintenance Period (MP)	Placebo, MP
STARTED	65 ^[1]	66 ^[2]
COMPLETED	15	11
NOT COMPLETED	50	55
Death	1	0
Adverse Event	1	3
Lack of Efficacy	25	24
Lost to Follow-up	1	2
Withdrawal by Subject	1	1
Administrative Reason By Sponsor	21	25

[1]	At end of IP, 65 participants met response criteria and were randomly assigned to abatacept in MP.
[2]	At end of IP, 66 participants met response criteria and were randomly assigned to placebo in MP.

Period 3: Open-Label Period (OL)

	Induction Period Cohort 1 (IP1C)-Abatacept (ABA) 30/~10 mg/kg	IP1C-ABA ~10 mg/kg	IP1C-ABA 3 mg/kg	IP1C-Placebo	IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg	IP2C-ABA ~10 mg/kg	ABA ~10 mg/kg, Maintenance Period (MP)	Placebo, MP	ABA ~10 mg/kg, Open-Label Period (OL)
STARTED	0	0	0	0	0	0	0	0	349 ^[1]
COMPLETED	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	349
Death	0	0	0	0	0	0	0	0	1
Adverse Event	0	0	0	0	0	0	0	0	10
Lack of Efficacy	0	0	0	0	0	0	0	0	161
Lost to Follow-up	0	0	0	0	0	0	0	0	4
Withdrawal by Subject	0	0	0	0	0	0	0	0	20
Pregnancy	0	0	0	0	0	0	0	0	1
Administrative Reason By Sponsor	0	0	0	0	0	0	0	0	145
Other	0	0	0	0	0	0	0	0	7

[1]	349 entered OL (those who completed IP but failed response criteria, or completed/relapsed on MP).

Baseline Characteristics

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Reporting Groups

	Description
Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg	During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
IP1C-ABA ~10 mg/kg	During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
IP1C-ABA 3 mg/kg	During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
IP1C-Placebo	During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg	During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
IP2C-ABA ~10 mg/kg	During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
Total	Total of all reporting groups

Baseline Measures

	Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg	IP1C-ABA ~10 mg/kg	IP1C-ABA 3 mg/kg	IP1C-Placebo	IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg	IP2C-ABA ~10 mg/kg	Total
Number of Participants [units: participants]	141	139	70	140	51	50	591
Age, Customized [units: participants]
<30 years	26	23	18	34	12	4	117
30-50 years	70	84	35	73	30	32	324
>50 years	45	32	17	33	9	14	150
Gender [units: participants]
Female	57	52	26	66	21	26	248
Male	84	87	44	74	30	24	343
Region of Enrollment [units: participants]
United States	43	42	22	55	20	13	195
Ireland	1	0	0	1	0	1	3
Italy	7	6	2	3	2	1	21
Switzerland	1	1	1	2	1	0	6
United Kingdom	0	0	0	3	2	4	9
India	12	12	10	10	5	2	51
France	7	12	6	6	1	5	37
Czech Republic	0	1	0	0	0	0	1
Mexico	20	14	10	8	7	9	68
Puerto Rico	0	1	0	1	0	0	2
Canada	9	12	2	13	1	3	40
Brazil	10	5	5	11	4	6	41
Poland	2	2	0	1	1	0	6
Belgium	4	6	1	5	0	1	17
Australia	8	7	4	13	1	1	34
South Africa	9	8	5	3	2	0	27
Germany	2	2	0	1	2	2	9
Netherlands	2	5	1	2	2	1	13
Korea, Republic of	4	3	1	2	0	1	11
Participants with Inadequate Response/Intolerance to Prior Anti-Tumor (TNF) Therapy (Infliximab) ^[1] [units: participants]
Inadequate Response/Intolerant to prior Infliximab	45	46	24	45	21	21	202
No Inadequate Response/Intolerance to Infliximab	96	93	46	95	30	29	389

[1]	Prior to this study, participants had an inadequate response and/or intolerance to an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Inadequate response was assessed by the treating physician and was primarily due to lack of efficacy. Because the treating physician determined prior inadequate response, there was no standard definition for this and criteria for determination may have varied between institutions. Intolerance was defined a an inability to achieve doses or treatment durations because of dose limiting side effects.

[1]

Prior to this study, participants had an inadequate response and/or intolerance to an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Inadequate response was assessed by the treating physician and was primarily due to lack of efficacy. Because the treating physician determined prior inadequate response, there was no standard definition for this and criteria for determination may have varied between institutions. Intolerance was defined a an inability to achieve doses or treatment durations because of dose limiting side effects.

Outcome Measures

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1. Primary:

Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) [ Time Frame: Week 12 (Day IP-85) ]

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2. Primary:

Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12 [ Time Frame: Month 12 (Day MP-365) ]

Show Outcome Measure 2

3. Primary:

Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation [ Time Frame: Day OL-1 through the end of the OL ]

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4. Primary:

OL; Number of Participants With AEs of Special Interest [ Time Frame: Day OL-1 through Day OL-729 ]

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5. Primary:

OL; Number of Participants With Physical Examination Findings [ Time Frame: Day OL-1 through Day OL-729 ]

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6. Primary:

OL; Number of Participants With Marked Hematology Laboratory Abnormalities [ Time Frame: Day OL-1 through Day OL-729 ]

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7. Primary:

OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities [ Time Frame: Day OL-1 through Day OL-729 ]

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8. Primary:

OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities [ Time Frame: Day OL-1 through Day OL-729 ]

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9. Secondary:

IP; Baseline Mayo Score: IP1C [ Time Frame: Baseline ]

Show Outcome Measure 9

10. Secondary:

IP; Number of Participants in Clinical Remission (Per Mayo Score) at Week 12: IP1C [ Time Frame: Week 12 (Day IP-85) ]

Show Outcome Measure 10

11. Secondary:

IP; Number of Participants in Mucosal Healing (Per Mayo Score) at Week 12: IP1C [ Time Frame: Week 12 (Day IP-85) ]

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12. Secondary:

IP; Number of Participants With Clinical Response (Per Mayo Score) at Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C [ Time Frame: Week 12 (Day IP-85) ]

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13. Secondary:

IP; Baseline Inflammatory Bowel Disease Questionnaire (IBDQ) Score: IP1C [ Time Frame: Baseline ]

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14. Secondary:

IP; Mean Change From Baseline To Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ): IP1C [ Time Frame: Baseline (Day IP-1), Day IP-85 (Week 12) ]

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15. Secondary:

IP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C [ Time Frame: Day IP-85 (Week 12) ]

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16. Secondary:

IP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C [ Time Frame: Day IP-85 (Week 12) ]

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17. Secondary:

IP; Number of Participants With Mayo Physician Global Assessment (PGA) Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C [ Time Frame: Day IP-85 (Week 12) ]

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18. Secondary:

IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With Clinical Response At Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C [ Time Frame: Week 12 (Day IP-85) ]

Show Outcome Measure 18

19. Secondary:

IP; Number of Participants With Clinical Response At Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C [ Time Frame: Week 12 (Day IP-85) ]

Show Outcome Measure 19

20. Secondary:

IP; Number of Participants in Clinical Remission at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C [ Time Frame: Week 12 (Day IP-85) ]

Show Outcome Measure 20

21. Secondary:

IP; Number of Participants in Mucosal Healing at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C [ Time Frame: Week 12 (Day IP-85) ]

Show Outcome Measure 21

22. Secondary:

IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation: IP1C + IP2C [ Time Frame: Day IP-1 through Day IP-85 ]

Show Outcome Measure 22

23. Secondary:

IP; Number of Participants With AEs Of Special Interest: IP1C + IP2C [ Time Frame: Day IP-1 through Day IP-85 ]

Show Outcome Measure 23

24. Secondary:

IP; Number of Participants With Physical Examination Findings: IP1C + IP2C [ Time Frame: Day IP-1 through Day IP-85 ]

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25. Secondary:

IP; Number of Participants With Marked Hematology Laboratory Abnormalities: IP1C [ Time Frame: Day IP-1 through Day IP-85 ]

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26. Secondary:

IP; Number of Participants With Marked Liver and Kidney Function and Electrolyte Laboratory Abnormalities: IP1C [ Time Frame: Day IP-1 through Day IP-85 ]

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27. Secondary:

IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP1C [ Time Frame: Day IP-1 through Day IP-85 ]

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28. Secondary:

IP; Number of Participants With Marked Hematology, Liver and Kidney Function, and Electrolyte Laboratory Abnormalities: IP2C [ Time Frame: Day IP-1 through Day IP-85 ]

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29. Secondary:

IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP2C [ Time Frame: Day IP-1 through Day IP-85 ]

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30. Secondary:

IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C [ Time Frame: For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85). For participants treated in OL directly after IP: Day IP-1 to Day OL-1. For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits) ]

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Measure Type	Secondary
Measure Title	IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C
Measure Description	A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.
Time Frame	For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85). For participants treated in OL directly after IP: Day IP-1 to Day OL-1. For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)
Safety Issue	No

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.
All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. "Positive" was defined as "positive post-baseline IP-1" and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed "negative" at baseline.

Reporting Groups

	Description
IP1C+IP2C: ABA 30/~10 mg/kg	During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
IP1C+IP2C: ABA ~10 mg/kg	During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
IP1C-ABA 3 mg/kg	During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.

Measured Values

	IP1C+IP2C: ABA 30/~10 mg/kg	IP1C+IP2C: ABA ~10 mg/kg	IP1C-ABA 3 mg/kg
Number of Participants Analyzed [units: participants]	189	185	66
IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C [units: participants]
Total	6	19	4
CTLA4/Possibly Ig	2	17	4
Ig and/or Ig Junction	4	3	0

No statistical analysis provided for IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C

31. Secondary:

MP; Number of Participants in Clinical Remission at Month 12 [ Time Frame: Month 12 (Day MP-365) ]

Show Outcome Measure 31

32. Secondary:

MP; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) at Month 12 [ Time Frame: Month 12 (Day MP-365) ]

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33. Secondary:

MP; Number of Participants in Clinical Remission at Both Month 6 and Month 12 [ Time Frame: Month 6 (Day MP-169), Month 12 (Day MP-365) ]

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34. Secondary:

MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids and Achieved Clinical Remission by Month 12 [ Time Frame: Day MP-365 (Month 12) ]

Show Outcome Measure 34

35. Secondary:

MP; Mean Change From Baseline to Month 12 in IBDQ [ Time Frame: Day MP-365 ]

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36. Secondary:

MP; Mean Change From Baseline to Month 12 in Short Form-36 (SF-36) [ Time Frame: Day MP-365 ]

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37. Secondary:

MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids for 90 Consecutive Days and Achieved Clinical Remission by Month 12 [ Time Frame: Day MP-365 (Month 12) ]

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38. Secondary:

MP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Month 12 [ Time Frame: Day MP-365 (Month 12) ]

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39. Secondary:

MP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Month 12 [ Time Frame: Day MP-365 (Month 12) ]

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40. Secondary:

MP; Number of Participants With Mayo PGA Subscores Indicating Mild Disease (≤1 Point) at Month 12 [ Time Frame: Day MP-365 (Month 12) ]

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41. Secondary:

MP; Number of Participants With Clinical Response at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) [ Time Frame: Month 12 (Day MP-365) ]

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42. Secondary:

MP; Number of Participants With Clinical Remission at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) [ Time Frame: Month 12 (Day MP-365) ]

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43. Secondary:

MP; Number of Participants With Clinical Mucosal Healing at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) [ Time Frame: Month 12 (Day MP-365) ]

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44. Secondary:

MP; Number of Participants With Abatacept-Induced Antibodies [ Time Frame: For participants not entering OL: All measurements starting after Day MP-1 (including follow-up visits). For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1). ]

Show Outcome Measure 44

45. Secondary:

MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation [ Time Frame: Day MP-1 through Day MP-365 ]

Show Outcome Measure 45

46. Secondary:

MP; Number of Participants With AEs of Special Interest [ Time Frame: Day MP-1 through Day MP-365 ]

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47. Secondary:

MP; Number of Participants With Physical Examination Findings [ Time Frame: Day IP-85 through Day MP-365 ]

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48. Secondary:

MP; Number of Participants With Marked Hematology Laboratory Abnormalities [ Time Frame: Day IP-85 through Day MP-365 ]

Show Outcome Measure 48

49. Secondary:

MP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities [ Time Frame: Day IP-85 through Day MP-365 ]

Show Outcome Measure 49

50. Secondary:

OL; Number of Participants With Clinical Response Over Time [ Time Frame: Day OL-1 through Day OL-729 ]

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51. Secondary:

OL; Number of Participants With Clinical Remission Over Time [ Time Frame: Day OL-1 through Day OL-729 ]

Show Outcome Measure 51

52. Secondary:

OL; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) During OL [ Time Frame: Open-Label Period (Day OL-1 through Day OL-729) ]

Show Outcome Measure 52

53. Secondary:

OL; Number of Participants With Clinical Response or Clinical Remission Upon Retreatment With Abatacept Among Those Who Received Abatacept in the IP or MP Period [ Time Frame: Last Study Visit (Day OL-729) ]

Show Outcome Measure 53

54. Secondary:

OL; Number of Participants With Abatacept-Induced Antibodies [ Time Frame: For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose) ]

Show Outcome Measure 54

55. Secondary:

OL; Number of Participants Using Corticosteroids During OL [ Time Frame: Day OL-1 through Day OL-729 ]

Show Outcome Measure 55

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:

	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
This study was terminated after review of the IP1C results due to lack of efficacy. Enrollment for the MP and for IP2C was not completed. Participants in MP, IP2C, and OL were early terminated at the time of study termination.

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:

Sandborn WJ, Colombel JF, Sands BE, Rutgeerts P, Targan SR, Panaccione R, Bressler B, Geboes K, Schreiber S, Aranda R, Gujrathi S, Luo A, Peng Y, Salter-Cid L, Hanauer SB. Abatacept for Crohn's disease and ulcerative colitis. Gastroenterology. 2012 Jul;143(1):62-69.e4. Epub 2012 Apr 12.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00410410 History of Changes
Other Study ID Numbers:	IM101-108
Study First Received:	December 11, 2006
Results First Received:	August 12, 2010
Last Updated:	November 4, 2010
Health Authority:	United States: Food and Drug Administration

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